Progesterone and Brain Imaging Study
Sponsor
University of Pennsylvania (Other)
Overall Status
Completed
CT.gov ID
NCT01954966
Collaborator
National Institute on Drug Abuse (NIDA) (NIH)
81
1
2
133
0.6
Study Details
Study Description
Brief Summary
Male and female smokers were recruited to undergo 2 phases of smoking cessation. Each phase was 4 days long and involved 3 brain-imaging scans, blood draws and an intervention involving progesterone or a matched placebo.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The purpose of this study is to learn whether a sex hormone called progesterone is helpful in reducing cigarette smoking and craving for cigarettes. This study also includes brain imaging to measure possible effects of progesterone on certain neurochemicals. These neurochemicals are called gamma-aminobutyric acid (or GABA for short) and glutamate. Both nicotine and progesterone affect these brain chemicals.
Individuals wishing to participate in this study must be medically healthy men or women who smoke at least 10 cigarettes per day or greater. Participants must not suffer from a mental illness or use drugs other than nicotine and marijuana. Participants cannot have any implanted metallic devices such as pacemakers, orthodontic braces, or shrapnel. Participants must not have peanut allergies and must never have had a reaction to progesterone. Finally, participants cannot be taking any medications for anxiety, depression or insomnia.
Study Design
Study Type:
Interventional
Actual Enrollment
:
81 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Multimodal Imaging of Progesterone/Neurosteroid Effects in Nicotine Addiction
Actual Study Start Date
:
Nov 1, 2010
Actual Primary Completion Date
:
Dec 1, 2021
Actual Study Completion Date
:
Dec 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Progesterone 200 mg capsules Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. |
Drug: Progesterone
Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
Other Names:
|
| Placebo Comparator: Progesterone 200 mg look-alike capsules Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. |
Drug: Placebo
Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
|
Outcome Measures
Primary Outcome Measures
- GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) [Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.]
GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex [DACC]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.
- GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]) [Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months.]
GABA concentrations (collected in the Dorsolateral Pre-Frontal Cortex [DLPFC]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA.
Secondary Outcome Measures
- Symptoms During Nicotine Abstinence (NWSC) [Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Withdrawal symptoms will be measured using the Nicotine Withdrawal Symptoms Checklist (NWSC). The scale ranges from a minimum of 0 to a maximum of 28, with higher scores indicating greater withdrawal (more withdrawal symptoms, higher intensity/severity of withdrawal).
- Brief Questionnaire on Smoking Urges (BQSU) [Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Craving will be assessed using the Brief Questionnaire on Smoking Urges (BQSU). It ranges from 7-70 with higher levels indicating higher levels of nicotine craving.
- Tiffany Questionnaire on Smoking Urges (TQSU) [Day 1 (pre smoking session, day 3 (PM), day 4 (PM), day 5 (pre smoking session)]
Craving will also be assessed using the Tiffany Questionnaire for Smoking Urges. It ranges from 32 to 224 with higher scores indicated higher levels of smoking urges/craving.
- Profile of Mood States (POMS) Subscale: Tension-Anxiety [Day 2 (pre and post scan), Day 5 (pre smoking session)]
Profile of Mood States (POMS) Subscale: Tension-Anxiety. This subscale ranges from 0-28 with higher levels indicating greater tension/anxiety.
- Profile of Mood States (POMS) Subscale: Depression-Dejection [Day 2 (pre and post scan), Day 5 (pre smoking session)]
Profile of Mood States (POMS) Subscale: Depression-Dejection. This subscale ranges from 0-60 with higher levels indicating greater depression/dejection.
- Profile of Mood States (POMS) Subscale: Anger-Hostility [Day 2 (pre and post scan), Day 5 (pre smoking session)]
Profile of Mood States (POMS) Subscale: Anger-Hostility. This scale ranges from 0 to 48 with higher levels indicating higher levels of anger/hostility.
- Profile of Mood States (POMS) Subscale: Fatigue [Day 2 (pre and post scan), Day 5 (pre smoking session)]
Profile of Mood States (POMS) Subscale: Fatigue. This subscale ranges from 0 to 28 with higher scores indicating higher levels of fatigue.
- Profile of Mood State (POMS) Subscale: Vigor [Day 2 (pre and post scan), Day 5 (pre smoking session)]
Profile of Mood State (POMS) Subscale: Vigor. Subscale ranges from 0 to 32, with higher levels indicating higher levels of vigor.
- Profile of Mood States (POMS) Subscale: Confusion-Bewilderment [Day 2 (pre and post scan), Day 5 (pre smoking session)]
Profile of Mood States (POMS) Subscale: Confusion-Bewilderment. Ranges from 0 to 28 with higher levels indicating higher levels of confusion/bewilderment.
- Visual Analog Scale (VAS) Question: Headache [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Hunger [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Hunger. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Nauseous [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Nauseous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Heartburn. [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Heartburn. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Tired [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Tired. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Irritable [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Irritable. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Energetic [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Energetic. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Relaxed [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Relaxed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Talkative [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Happy [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Happy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Nervous [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Nervous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Sad [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Sad. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Calm [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Calm. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Depressed [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Depressed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Drowsy [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Drowsy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Visual Analog Scale (VAS) Question: Anxious [Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Visual Analog Scale (VAS) question: Anxious. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling.
- Positive and Negative Affect Schedule (PANAS) Negative Affect [Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Positive and Negative Affect Schedule (PANAS) Negative Affect Score. Ranges from 10-50 with higher scores representing higher levels of negative affect.
- Positive and Negative Affect Schedule (PANAS) Positive Affect [Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session)]
Positive and Negative Affect Schedule (PANAS) Positive Affect Score. Ranges from 10-50 with higher scores representing higher levels of positive affect.
- Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine [Day 1 (pre smoking session), Day 5 (post smoking session)]
Nicotine Effects Questionnaire (NEQ) question: feels strength of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling stronger effects of nicotine after smoking.
- Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine [Day 1 (pre smoking session), Day 5 (post smoking session)]
NEQ question: feels good effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more good effects of nicotine after smoking.
- Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine [Day 1 (pre smoking session), Day 5 (post smoking session)]
Nicotine Effects Questionnaire (NEQ) question: feels bad effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more bad effects of nicotine after smoking.
- Nicotine Effects Questionnaire (NEQ) Question: Head Rush [Day 1 (pre smoking session), Day 5 (post smoking session)]
Nicotine Effects Questionnaire (NEQ) question: feels head rush. Score ranges from 0 to 100 with higher levels indicating feeling stronger/more intense head rush after smoking.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Female and male smokers, aged 18 to 50 years;
-
History of smoking greater than or equal to 10 cigarettes daily for the past year, as per self-report (periods of smoking abstinence within the last year will be exclusionary at PI discretion);
-
Not seeking treatment at the time of the study for nicotine dependence;
-
Have a Fagerstrom Test for Nicotine Dependence (FTND) score of at least 3 and a Carbon Monoxide (CO) level greater than or equal to 11 ppm;
-
Clean urine drug screen (marijuana is permissible);
-
In good health as verified by medical history;
-
For women, not pregnant as determined by pregnancy screening, nor breast feeding.
Exclusion Criteria:
-
History of major medical illness: including liver diseases, abnormal vaginal bleeding, suspected or known malignancy; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; history of stroke or other medical conditions that the physician investigator deems as contraindicated for the patient to be in the study;
-
Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent (within previous year) psychiatric diagnosis and treatment for Axis I disorders including major depression, bipolar affective disorder, generalized anxiety disorder, post-traumatic stress disorder and panic disorder;
-
Lifetime history of schizophrenia or other psychotic disorder;
-
Lifetime substance dependence disorder, excepting nicotine, alcohol and marijuana, as per SCID interview
-
Substance use disorders within the previous 2 years, excepting nicotine, as per SCID interview
-
Regular use of any other tobacco products than cigarettes, including smokeless tobacco and nicotine products;
-
Known allergy to progesterone or peanuts (vehicle for micronized progesterone).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Penn Center for Women's Behavioral Wellness | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Cynthia N Epperson, M.D., Associate Professor of Psychiatry, University of Pennsylvania
Study Documents (Full-Text)
More Information
Additional Information:
Publications
- Cai K, Nanga RP, Lamprou L, Schinstine C, Elliott M, Hariharan H, Reddy R, Epperson CN. The impact of gabapentin administration on brain GABA and glutamate concentrations: a 7T ¹H-MRS study. Neuropsychopharmacology. 2012 Dec;37(13):2764-71. doi: 10.1038/npp.2012.142. Epub 2012 Aug 8.
- Cosgrove KP, Mitsis EM, Bois F, Frohlich E, Tamagnan GD, Krantzler E, Perry E, Maciejewski PK, Epperson CN, Allen S, O'malley S, Mazure CM, Seibyl JP, van Dyck CH, Staley JK. 123I-5-IA-85380 SPECT imaging of nicotinic acetylcholine receptor availability in nonsmokers: effects of sex and menstrual phase. J Nucl Med. 2007 Oct;48(10):1633-40. Epub 2007 Sep 14.
- Epperson CN, O'Malley S, Czarkowski KA, Gueorguieva R, Jatlow P, Sanacora G, Rothman DL, Krystal JH, Mason GF. Sex, GABA, and nicotine: the impact of smoking on cortical GABA levels across the menstrual cycle as measured with proton magnetic resonance spectroscopy. Biol Psychiatry. 2005 Jan 1;57(1):44-8.
- Epperson CN, Toll B, Wu R, Amin Z, Czarkowski KA, Jatlow P, Mazure CM, O'Malley SS. Exploring the impact of gender and reproductive status on outcomes in a randomized clinical trial of naltrexone augmentation of nicotine patch. Drug Alcohol Depend. 2010 Nov 1;112(1-2):1-8. doi: 10.1016/j.drugalcdep.2010.04.021. Epub 2010 Jun 19.
- Mason GF, Petrakis IL, de Graaf RA, Gueorguieva R, Guidone E, Coric V, Epperson CN, Rothman DL, Krystal JH. Cortical gamma-aminobutyric acid levels and the recovery from ethanol dependence: preliminary evidence of modification by cigarette smoking. Biol Psychiatry. 2006 Jan 1;59(1):85-93. Epub 2005 Nov 14.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01954966
Other Study ID Numbers:
- 811940
- K24DA030301
First Posted:
Oct 7, 2013
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | There were 81 participants who were enrolled in the study, but N = 15 were lost to early follow-up before they could be randomized. Therefore, only N = 66 participants were randomized (N = 34 randomized to receive placebo first, N = 32 randomized to receive progesterone first). |
| Arm/Group Title | Placebo First, Progesterone Second | Progesterone First, Placebo Second |
|---|---|---|
| Arm/Group Description | This group was randomized to receive placebo during phase 1 of the crossover trial and progesterone during phase 2 of the crossover trial. | This group was randomized to receive progesterone during phase 1 of the crossover trial and placebo during phase 2 of the crossover trial. |
| Period Title: Overall Study | ||
| STARTED | 34 | 32 |
| Completed Week 1 of Intervention (Drug Assigned to Receive First) | 30 | 30 |
| Started Phase 2 After Washout Period (1-2 Week for Males, 1-3 Month for Females) | 30 | 30 |
| Completed Week 2 of Intervention (Drug Assigned to Receive Second) | 24 | 28 |
| COMPLETED | 24 | 28 |
| NOT COMPLETED | 10 | 4 |
Baseline Characteristics
| Arm/Group Title | Placebo First, Progesterone Second | Progesterone First, Placebo Second | Total |
|---|---|---|---|
| Arm/Group Description | This group was randomized to receive placebo during phase 1 of the crossover trial and progesterone during phase 2 of the crossover trial. | This group was randomized to receive progesterone during phase 1 of the crossover trial and placebo during phase 2 of the crossover trial. | Total of all reporting groups |
| Overall Participants | 34 | 32 | 66 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
35.5
(9.0)
|
37.7
(7.6)
|
36.6
(8.4)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
16
47.1%
|
17
53.1%
|
33
50%
|
| Male |
18
52.9%
|
15
46.9%
|
33
50%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
2
5.9%
|
3
9.4%
|
5
7.6%
|
| Not Hispanic or Latino |
31
91.2%
|
27
84.4%
|
58
87.9%
|
| Unknown or Not Reported |
1
2.9%
|
2
6.3%
|
3
4.5%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
1
3.1%
|
1
1.5%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
22
64.7%
|
22
68.8%
|
44
66.7%
|
| White |
8
23.5%
|
5
15.6%
|
13
19.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
4
11.8%
|
4
12.5%
|
8
12.1%
|
Outcome Measures
| Title | GABA Pre and Post Progesterone Administration (Dorsal Anterior Cingulate Cortex [DACC]) |
|---|---|
| Description | GABA concentrations (collected in the Dorsal Anterior Cingulate Cortex [DACC]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA. |
| Time Frame | Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some values were missing due to visits for these individuals scheduled after there were issues with the 7T scanner, so data could not be collected for other participants. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 10 | 12 |
| Test day 2 (baseline, pre-scan) |
1.23
(0.05)
|
1.17
(0.04)
|
| Test day 2 (post-scan) |
1.28
(0.05)
|
1.24
(0.04)
|
| Test day 5 (pre-smoking) |
1.21
(0.05)
|
1.17
(0.05)
|
| Title | GABA Pre and Post Progesterone Administration (Dorsolateral Pre-Frontal Cortex [DLPFC]) |
|---|---|
| Description | GABA concentrations (collected in the Dorsolateral Pre-Frontal Cortex [DLPFC]) will be obtained using the non-invasive neuroimaging method of proton magnetic resonance spectroscopy (1H-MRS) both before and after placebo administration and smoking abstinence. In total subjects will undergo 6 1H-MRS scans. The 6 1H-MRS scans take place over a period of approximately 1-2 months. Each paradigm (placebo/progesterone) takes approximately one week, with an approximately two-week wash in between paradigms for men and an approximately 1-month wash in between paradigms for women. The subject will undergo a smoking session on Test Day #1 and Test Day #5, MRS scans are conducted on Test Day #2 (2 scans) and Test Day #5 (1 scan). Minimal data is available for the primary outcome due to substantial issues with the 7T scanner. All subsequent scans were conducted on a 3T scanner which does not have the capacity to collect data on GABA. |
| Time Frame | Test Day #2 and Test Day #5 - 6 total scans over the period of 2-3 months. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data was not collected for participants due to issues with the 7T. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 10 | 12 |
| Day 2- pre scan |
1.18
(0.13)
|
1.20
(0.11)
|
| Day 2- post scan |
1.05
(0.13)
|
0.98
(0.12)
|
| Day 5- after scan, pre smoking |
1.06
(0.11)
|
1.11
(0.16)
|
| Title | Symptoms During Nicotine Abstinence (NWSC) |
|---|---|
| Description | Withdrawal symptoms will be measured using the Nicotine Withdrawal Symptoms Checklist (NWSC). The scale ranges from a minimum of 0 to a maximum of 28, with higher scores indicating greater withdrawal (more withdrawal symptoms, higher intensity/severity of withdrawal). |
| Time Frame | Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some secondary outcome data is missing because missed visits and dropouts occurred due to the number of visits required for the study. The study team attempted to limit missing data with payment at each visit for contingency management and allowing participants to continue in the study if individual visits were missed. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Nicotine withdrawal symptoms checklist (NWSC); day 1 pre 1st smoking session |
6.00
(0.59)
|
6.15
(0.58)
|
| Nicotine withdrawal symptoms checklist (NWSC); day 1 post 1st smoking session |
4.84
(0.60)
|
4.48
(0.59)
|
| Nicotine withdrawal symptoms checklist (NWSC); day 2 pre-scan |
5.67
(0.59)
|
4.92
(0.59)
|
| Nicotine withdrawal symptoms checklist (NWSC); day 2 post-scan |
5.37
(0.60)
|
5.25
(0.60)
|
| Nicotine withdrawal symptoms checklist (NWSC); day 3 abstinence AM |
7.07
(0.60)
|
7.62
(0.60)
|
| Nicotine withdrawal symptoms checklist (NWSC); day 3 abstinence PM |
6.99
(0.60)
|
7.88
(0.60)
|
| Nicotine withdrawal symptoms checklist (NWSC); day 4 abstinence AM |
7.33
(0.60)
|
7.66
(0.60)
|
| Nicotine withdrawal symptoms checklist (NWSC); day 4 abstinence PM |
7.19
(0.60)
|
7.32
(0.61)
|
| Nicotine withdrawal symptoms checklist (NWSC); day 5 pre-smoking |
7.01
(0.60)
|
7.34
(0.62)
|
| Nicotine withdrawal symptoms checklist (NWSC); day 5 post-smoking |
4.60
(0.60)
|
4.82
(0.65)
|
| Title | Brief Questionnaire on Smoking Urges (BQSU) |
|---|---|
| Description | Craving will be assessed using the Brief Questionnaire on Smoking Urges (BQSU). It ranges from 7-70 with higher levels indicating higher levels of nicotine craving. |
| Time Frame | Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 1; pre-1st smoking session |
40.89
(2.23)
|
41.94
(2.16)
|
| Day 1; post-1st smoking session |
30.45
(2.33)
|
25.77
(2.22)
|
| Day 2; pre-1st scan |
38.47
(2.28)
|
34.34
(2.19)
|
| Day 2; post-2nd scan |
38.81
(2.31)
|
37.98
(2.26)
|
| Day 3; abstinence AM |
41.91
(2.28)
|
41.82
(2.26)
|
| Day 3; abstinence PM |
40.84
(2.28)
|
42.03
(2.25)
|
| Day 4; abstinence AM |
40.90
(2.30)
|
40.29
(2.26)
|
| Day 4; abstinence PM |
39.23
(2.28)
|
37.68
(2.30)
|
| Day 5; after scan, pre-smoking |
41.95
(2.26)
|
42.38
(2.35)
|
| Day 5; after smoking |
27.64
(2.29)
|
28.22
(2.42)
|
| Title | Tiffany Questionnaire on Smoking Urges (TQSU) |
|---|---|
| Description | Craving will also be assessed using the Tiffany Questionnaire for Smoking Urges. It ranges from 32 to 224 with higher scores indicated higher levels of smoking urges/craving. |
| Time Frame | Day 1 (pre smoking session, day 3 (PM), day 4 (PM), day 5 (pre smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 1; pre-1st smoking session |
143.45
(5.13)
|
140.31
(5.00)
|
| Day 3; abstinence PM |
138.46
(5.23)
|
140.77
(5.29)
|
| Day 4; abstinence PM |
139.11
(5.17)
|
135.88
(5.36)
|
| Day 5; after scan, pre-smoking |
146.22
(5.11)
|
141.08
(5.36)
|
| Title | Profile of Mood States (POMS) Subscale: Tension-Anxiety |
|---|---|
| Description | Profile of Mood States (POMS) Subscale: Tension-Anxiety. This subscale ranges from 0-28 with higher levels indicating greater tension/anxiety. |
| Time Frame | Day 2 (pre and post scan), Day 5 (pre smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
2.88
(0.46)
|
2.57
(0.46)
|
| Day 2; post- 2nd scan |
3.55
(0.47)
|
3.11
(0.47)
|
| Day 5; after scan, pre-smoking |
4.85
(0.47)
|
3.70
(0.50)
|
| Title | Profile of Mood States (POMS) Subscale: Depression-Dejection |
|---|---|
| Description | Profile of Mood States (POMS) Subscale: Depression-Dejection. This subscale ranges from 0-60 with higher levels indicating greater depression/dejection. |
| Time Frame | Day 2 (pre and post scan), Day 5 (pre smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
1.09
(0.34)
|
0.64
(0.34)
|
| Day 2; post-2nd scan |
1.30
(0.35)
|
0.88
(0.35)
|
| Day 5; after scan, pre-smoking |
1.66
(0.35)
|
1.81
(0.37)
|
| Title | Profile of Mood States (POMS) Subscale: Anger-Hostility |
|---|---|
| Description | Profile of Mood States (POMS) Subscale: Anger-Hostility. This scale ranges from 0 to 48 with higher levels indicating higher levels of anger/hostility. |
| Time Frame | Day 2 (pre and post scan), Day 5 (pre smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
0.94
(0.36)
|
0.83
(0.36)
|
| Day 2; post-2nd scan |
1.55
(0.37)
|
1.41
(0.37)
|
| Day 5; after scan, pre-smoking |
2.70
(0.37)
|
2.36
(0.39)
|
| Title | Profile of Mood States (POMS) Subscale: Fatigue |
|---|---|
| Description | Profile of Mood States (POMS) Subscale: Fatigue. This subscale ranges from 0 to 28 with higher scores indicating higher levels of fatigue. |
| Time Frame | Day 2 (pre and post scan), Day 5 (pre smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
2.17
(0.48)
|
1.77
(0.49)
|
| Day 2; post-2nd scan |
2.84
(0.50)
|
3.63
(0.49)
|
| Day 5; after scan, pre-smoking |
3.66
(0.50)
|
3.10
(0.53)
|
| Title | Profile of Mood State (POMS) Subscale: Vigor |
|---|---|
| Description | Profile of Mood State (POMS) Subscale: Vigor. Subscale ranges from 0 to 32, with higher levels indicating higher levels of vigor. |
| Time Frame | Day 2 (pre and post scan), Day 5 (pre smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
18.71
(0.94)
|
18.71
(0.95)
|
| Day 2; post-2nd scan |
16.74
(0.96)
|
16.73
(0.96)
|
| Day 5; after scan, pre-smoking |
16.71
(0.96)
|
16.39
(0.98)
|
| Title | Profile of Mood States (POMS) Subscale: Confusion-Bewilderment |
|---|---|
| Description | Profile of Mood States (POMS) Subscale: Confusion-Bewilderment. Ranges from 0 to 28 with higher levels indicating higher levels of confusion/bewilderment. |
| Time Frame | Day 2 (pre and post scan), Day 5 (pre smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
2.47
(0.35)
|
2.31
(0.35)
|
| Day 2; post-2nd scan |
2.95
(0.36)
|
2.98
(0.35)
|
| Day 5; after scan, pre-smoking |
3.46
(0.36)
|
2.80
(0.37)
|
| Title | Visual Analog Scale (VAS) Question: Headache |
|---|---|
| Description | Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
6.50
(2.55)
|
7.59
(2.54)
|
| Day 2; post-2nd scan |
5.74
(2.55)
|
9.39
(2.57)
|
| Day 3; abstinence AM |
9.15
(2.65)
|
14.71
(2.65)
|
| Day 3; abstinence PM |
8.86
(2.67)
|
10.93
(2.65)
|
| Day 4; abstinence AM |
10.88
(2.65)
|
7.70
(2.67)
|
| Day 4; abstinence PM |
11.83
(2.65)
|
12.78
(2.71)
|
| Day 5; after scan, pre-smoking |
9.05
(2.59)
|
13.36
(2.71)
|
| Day 5; after smoking |
11.93
(2.59)
|
11.67
(2.75)
|
| Title | Visual Analog Scale (VAS) Question: Hunger |
|---|---|
| Description | Visual Analog Scale (VAS) question: Hunger. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
34.60
(3.73)
|
40.23
(3.70)
|
| Day 2; post-2nd scan |
28.63
(3.75)
|
22.20
(3.73)
|
| Day 3; abstinence AM |
24.88
(3.85)
|
33.40
(3.85)
|
| Day 3; abstinence PM |
27.72
(3.87)
|
31.95
(3.85)
|
| Day 4; abstinence AM |
27.94
(3.85)
|
34.64
(3.88)
|
| Day 4; abstinence PM |
25.57
(3.85)
|
29.27
(3.93)
|
| Day 5; after scan, pre-smoking |
28.22
(3.78)
|
35.22
(3.93)
|
| Day 5; after smoking |
28.63
(3.78)
|
32.61
(3.99)
|
| Title | Visual Analog Scale (VAS) Question: Nauseous |
|---|---|
| Description | Visual Analog Scale (VAS) question: Nauseous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
5.52
(2.07)
|
4.92
(2.06)
|
| Day 2; post-2nd scan |
6.31
(2.07)
|
5.43
(2.08)
|
| Day 3; abstinence AM |
6.01
(2.14)
|
10.44
(2.14)
|
| Day 3; abstinence PM |
8.07
(2.15)
|
9.85
(2.14)
|
| Day 4; abstinence AM |
6.07
(2.14)
|
8.22
(2.15)
|
| Day 4; abstinence PM |
6.60
(2.18)
|
10.29
(2.18)
|
| Day 5; after scan, pre-smoking |
6.51
(2.10)
|
10.34
(2.18)
|
| Day 5; after smoking |
8.00
(2.10)
|
11.41
(2.22)
|
| Title | Visual Analog Scale (VAS) Question: Heartburn. |
|---|---|
| Description | Visual Analog Scale (VAS) question: Heartburn. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
3.11
(1.70)
|
2.35
(1.69)
|
| Day 2; post-2nd scan |
4.30
(1.70)
|
4.06
(1.71)
|
| Day 3; abstinence AM |
5.46
(1.76)
|
3.27
(1.76)
|
| Day 3; abstinence PM |
6.00
(1.78)
|
4.55
(1.76)
|
| Day 4; abstinence AM |
7.31
(1.76)
|
6.50
(1.78)
|
| Day 4; abstinence PM |
5.51
(1.76)
|
5.56
(1.80)
|
| Day 5; after scan, pre-smoking |
4.33
(1.73)
|
5.30
(1.80)
|
| Day 5; after smoking |
4.56
(1.73)
|
6.37
(1.83)
|
| Title | Visual Analog Scale (VAS) Question: Tired |
|---|---|
| Description | Visual Analog Scale (VAS) question: Tired. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
24.15
(3.76)
|
18.62
(3.74)
|
| Day 2; post-2nd scan |
29.67
(3.76)
|
40.92
(3.79)
|
| Day 3; abstinence AM |
21.64
(3.89)
|
27.24
(3.89)
|
| Day 3; abstinence PM |
30.82
(3.91)
|
35.53
(3.89)
|
| Day 4; abstinence AM |
31.73
(3.89)
|
27.99
(3.92)
|
| Day 4; abstinence PM |
30.69
(3.89)
|
28.51
(3.97)
|
| Day 5; after scan, pre-smoking |
33.94
(3.82)
|
32.06
(3.97)
|
| Day 5; after smoking |
31.22
(3.82)
|
34.79
(4.03)
|
| Title | Visual Analog Scale (VAS) Question: Irritable |
|---|---|
| Description | Visual Analog Scale (VAS) question: Irritable. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
7.50
(3.42)
|
5.71
(3.40)
|
| Day 2; post-2nd scan |
13.20
(3.42)
|
13.01
(3.44)
|
| Day 3; abstinence AM |
24.80
(3.54)
|
24.56
(3.54)
|
| Day 3; abstinence PM |
23.97
(3.56)
|
25.49
(3.54)
|
| Day 4; abstinence AM |
30.79
(3.54)
|
29.58
(3.56)
|
| Day 4; abstinence PM |
26.50
(3.54)
|
30.11
(3.61)
|
| Day 5; after scan, pre-smoking |
23.23
(3.47)
|
22.96
(3.61)
|
| Day 5; after smoking |
13.45
(3.47)
|
15.52
(3.66)
|
| Title | Visual Analog Scale (VAS) Question: Energetic |
|---|---|
| Description | Visual Analog Scale (VAS) question: Energetic. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
54.86
(3.68)
|
67.01
(3.66)
|
| Day 2; post-2nd scan |
55.18
(3.68)
|
21.03
(3.69)
|
| Day 3; abstinence AM |
56.14
(3.77)
|
58.11
(3.77)
|
| Day 3; abstinence PM |
56.13
(3.79)
|
50.12
(3.77)
|
| Day 4; abstinence AM |
55.62
(3.77)
|
54.89
(3.79)
|
| Day 4; abstinence PM |
53.45
(3.77)
|
56.77
(3.83)
|
| Day 5; after scan, pre-smoking |
51.47
(3.72)
|
56.64
(3.83)
|
| Day 5; after smoking |
54.79
(3.72)
|
54.70
(3.87)
|
| Title | Visual Analog Scale (VAS) Question: Relaxed |
|---|---|
| Description | Visual Analog Scale (VAS) question: Relaxed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
72.66
(3.64)
|
73.87
(3.64)
|
| Day 2; post-2nd scan |
67.77
(3.64)
|
63.65
(3.67)
|
| Day 3; abstinence AM |
63.87
(3.75)
|
55.85
(3.77)
|
| Day 3; abstinence PM |
57.69
(3.77)
|
54.08
(3.77)
|
| Day 4; abstinence AM |
57.83
(3.75)
|
55.37
(3.79)
|
| Day 4; abstinence PM |
63.46
(3.75)
|
63.45
(3.84)
|
| Day 5; after scan, pre-smoking |
62.45
(3.68)
|
67.65
(3.81)
|
| Day 5; after smoking |
67.99
(3.86)
|
67.55
(3.68)
|
| Title | Visual Analog Scale (VAS) Question: Talkative |
|---|---|
| Description | Visual Analog Scale (VAS) question: Headache. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
54.17
(3.76)
|
57.46
(3.75)
|
| Day 2; post-2nd scan |
50.61
(3.76)
|
51.46
(3.78)
|
| Day 3; abstinence AM |
51.43
(3.84)
|
50.34
(3.84)
|
| Day 3; abstinence PM |
48.14
(3.86)
|
47.04
(3.84)
|
| Day 4; abstinence AM |
49.67
(3.84)
|
50.71
(3.86)
|
| Day 4; abstinence PM |
50.48
(3.84)
|
49.27
(3.90)
|
| Day 5; after scan, pre-smoking |
52.74
(3.80)
|
56.19
(3.90)
|
| Day 5; after smoking |
54.26
(3.80)
|
53.12
(3.93)
|
| Title | Visual Analog Scale (VAS) Question: Happy |
|---|---|
| Description | Visual Analog Scale (VAS) question: Happy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
76.62
(3.39)
|
79.70
(3.37)
|
| Day 2; post-2nd scan |
70.98
(3.39)
|
71.34
(3.40)
|
| Day 3; abstinence AM |
66.22
(3.47)
|
64.04
(3.47)
|
| Day 3; abstinence PM |
65.10
(3.49)
|
61.30
(3.47)
|
| Day 4; abstinence AM |
62.76
(3.47)
|
60.58
(3.49)
|
| Day 4; abstinence PM |
61.99
(3.47)
|
63.95
(3.52)
|
| Day 5; after scan, pre-smoking |
66.59
(3.42)
|
63.46
(3.52)
|
| Day 5; after smoking |
70.07
(3.42)
|
67.87
(3.56)
|
| Title | Visual Analog Scale (VAS) Question: Nervous |
|---|---|
| Description | Visual Analog Scale (VAS) question: Nervous. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
13.24
(2.50)
|
10.26
(2.49)
|
| Day 2; post-2nd scan |
10.91
(2.50)
|
8.46
(2.52)
|
| Day 3; abstinence AM |
7.19
(2.57)
|
8.22
(2.57)
|
| Day 3; abstinence PM |
9.56
(2.59)
|
9.24
(2.57)
|
| Day 4; abstinence AM |
9.36
(2.57)
|
11.37
(2.59)
|
| Day 4; abstinence PM |
10.83
(2.57)
|
10.66
(2.62)
|
| Day 5; after scan, pre-smoking |
10.79
(2.53)
|
12.15
(2.62)
|
| Day 5; after smoking |
7.64
(2.53)
|
11.94
(2.65)
|
| Title | Visual Analog Scale (VAS) Question: Sad |
|---|---|
| Description | Visual Analog Scale (VAS) question: Sad. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
3.95
(1.87)
|
2.09
(1.85)
|
| Day 2; post-2nd scan |
6.77
(1.87)
|
4.48
(1.88)
|
| Day 3; abstinence AM |
5.67
(1.93)
|
10.51
(1.93)
|
| Day 3; abstinence PM |
4.36
(1.95)
|
9.07
(1.93)
|
| Day 4; abstinence AM |
8.54
(1.93)
|
8.47
(1.95)
|
| Day 4; abstinence PM |
7.32
(1.93)
|
8.65
(1.98)
|
| Day 5; after scan, pre-smoking |
3.87
(1.89)
|
12.47
(1.98)
|
| Day 5; after smoking |
2.95
(1.89)
|
5.92
(2.01)
|
| Title | Visual Analog Scale (VAS) Question: Calm |
|---|---|
| Description | Visual Analog Scale (VAS) question: Calm. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
74.35
(3.60)
|
76.52
(3.58)
|
| Day 2; post-2nd scan |
73.15
(3.60)
|
69.23
(3.62)
|
| Day 3; abstinence AM |
65.65
(3.71)
|
61.15
(3.71)
|
| Day 3; abstinence PM |
58.92
(3.73)
|
52.44
(3.71)
|
| Day 4; abstinence AM |
60.23
(3.71)
|
57.97
(3.73)
|
| Day 4; abstinence PM |
65.47
(3.71)
|
62.48
(3.78)
|
| Day 5; after scan, pre-smoking |
67.60
(3.78)
|
61.02
(3.65)
|
| Day 5; after smoking |
69.27
(3.65)
|
70.52
(3.83)
|
| Title | Visual Analog Scale (VAS) Question: Depressed |
|---|---|
| Description | Visual Analog Scale (VAS) question: Depressed. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
3.97
(1.52)
|
2.87
(1.52)
|
| Day 2; post-2nd scan |
4.99
(1.52)
|
5.55
(1.53)
|
| Day 3; abstinence AM |
6.43
(1.57)
|
6.85
(1.57)
|
| Day 3; abstinence PM |
4.61
(1.58)
|
4.58
(1.57)
|
| Day 4; abstinence AM |
5.51
(1.57)
|
5.17
(1.58)
|
| Day 4; abstinence PM |
5.67
(1.57)
|
5.73
(1.60)
|
| Day 5; after scan, pre-smoking |
2.64
(1.54)
|
5.26
(1.60)
|
| Day 5; after smoking |
2.53
(1.54)
|
4.89
(1.63)
|
| Title | Visual Analog Scale (VAS) Question: Drowsy |
|---|---|
| Description | Visual Analog Scale (VAS) question: Drowsy. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
16.63
(3.53)
|
14.29
(3.51)
|
| Day 2; post-2nd scan |
24.25
(3.53)
|
30.17
(3.55)
|
| Day 3; abstinence AM |
17.14
(3.65)
|
15.43
(3.65)
|
| Day 3; abstinence PM |
24.71
(3.67)
|
24.36
(3.65)
|
| Day 4; abstinence AM |
19.56
(3.65)
|
18.32
(3.67)
|
| Day 4; abstinence PM |
19.84
(3.65)
|
20.50
(3.72)
|
| Day 5; after scan, pre-smoking |
23.01
(3.58)
|
21.01
(3.72)
|
| Day 5; after smoking |
20.45
(3.58)
|
21.45
(3.78)
|
| Title | Visual Analog Scale (VAS) Question: Anxious |
|---|---|
| Description | Visual Analog Scale (VAS) question: Anxious. Scale ranges from 0 to 100 with higher levels indicating greater intensity of symptom/feeling. |
| Time Frame | Day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 2; pre-1st scan |
16.69
(3.30)
|
15.62
(3.28)
|
| Day 2; post-2nd scan |
15.02
(3.30)
|
12.65
(3.31)
|
| Day 3; abstinence AM |
20.20
(3.38)
|
17.38
(3.38)
|
| Day 3; abstinence PM |
16.38
(3.40)
|
20.23
(3.38)
|
| Day 4; abstinence AM |
18.46
(3.38)
|
15.08
(3.40)
|
| Day 4; abstinence PM |
15.88
(3.38)
|
15.63
(3.44)
|
| Day 5; after scan, pre-smoking |
17.81
(3.33)
|
19.05
(3.44)
|
| Day 5; after smoking |
16.26
(3.33)
|
15.30
(3.48)
|
| Title | Positive and Negative Affect Schedule (PANAS) Negative Affect |
|---|---|
| Description | Positive and Negative Affect Schedule (PANAS) Negative Affect Score. Ranges from 10-50 with higher scores representing higher levels of negative affect. |
| Time Frame | Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 1; pre-1st smoking session |
11.94
(0.45)
|
11.43
(0.44)
|
| Day 1; post-1st smoking session |
10.64
(0.46)
|
10.57
(0.45)
|
| Day 2; pre-1st scan |
11.25
(0.45)
|
11.03
(0.44)
|
| Day 2; post-2nd scan |
11.59
(0.46)
|
11.49
(0.45)
|
| Day 3; abstinence AM |
12.31
(0.46)
|
13.01
(0.46)
|
| Day 3; abstinence PM |
13.07
(0.45)
|
12.89
(0.45)
|
| Day 4; abstinence AM |
12.51
(0.45)
|
13.06
(0.46)
|
| Day 4; abstinence PM |
12.90
(0.45)
|
13.16
(0.46)
|
| Day 5; after scan, pre-smoking |
12.55
(0.45)
|
12.18
(0.47)
|
| Day 5; after smoking |
11.41
(0.47)
|
11.94
(0.48)
|
| Title | Positive and Negative Affect Schedule (PANAS) Positive Affect |
|---|---|
| Description | Positive and Negative Affect Schedule (PANAS) Positive Affect Score. Ranges from 10-50 with higher scores representing higher levels of positive affect. |
| Time Frame | Day 1 (pre and post smoking session, day 2 (pre and post scan), day 3 (AM and PM), day 4 (AM and PM), day 5 (pre and post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 1; pre-1st smoking session |
37.10
(1.24)
|
37.23
(1.23)
|
| Day 1; post-1st smoking session |
35.72
(1.25)
|
36.11
(1.24)
|
| Day 2; pre-1st scan |
36.08
(1.24)
|
36.55
(1.23)
|
| Day 2; post-2nd scan |
33.51
(1.25)
|
34.17
(1.25)
|
| Day 3; abstinence AM |
32.57
(1.25)
|
33.30
(1.25)
|
| Day 3; abstinence PM |
32.34
(1.25)
|
32.81
(1.25)
|
| Day 4; abstinence AM |
32.56
(1.25)
|
32.03
(1.25)
|
| Day 4; abstinence PM |
33.25
(1.25)
|
32.61
(1.26)
|
| Day 5; after scan, pre-smoking |
33.45
(1.25)
|
32.53
(1.27)
|
| Day 5; after smoking |
33.10
(1.25)
|
33.76
(1.27)
|
| Title | Nicotine Effects Questionnaire (NEQ) Question: Feels Strength of Nicotine |
|---|---|
| Description | Nicotine Effects Questionnaire (NEQ) question: feels strength of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling stronger effects of nicotine after smoking. |
| Time Frame | Day 1 (pre smoking session), Day 5 (post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 1; pre-1st smoking session |
71.45
(3.55)
|
71.01
(3.51)
|
| Day 5; after smoking |
74.87
(3.60)
|
75.25
(3.79)
|
| Title | Nicotine Effects Questionnaire (NEQ) Question: Feels Good Effects of Nicotine |
|---|---|
| Description | NEQ question: feels good effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more good effects of nicotine after smoking. |
| Time Frame | Day 1 (pre smoking session), Day 5 (post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 1; pre-1st smoking session |
67.72
(3.75)
|
67.84
(3.71)
|
| Day 5; after smoking |
67.84
(3.80)
|
64.72
(3.99)
|
| Title | Nicotine Effects Questionnaire (NEQ) Question: Feels Bad Effects of Nicotine |
|---|---|
| Description | Nicotine Effects Questionnaire (NEQ) question: feels bad effects of nicotine. Score ranges from 0 to 100 with higher levels indicating feeling more bad effects of nicotine after smoking. |
| Time Frame | Day 1 (pre smoking session), Day 5 (post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 1; pre-1st smoking session |
26.25
(3.91)
|
25.92
(3.86)
|
| Day 5; after smoking |
25.39
(3.96)
|
28.70
(4.19)
|
| Title | Nicotine Effects Questionnaire (NEQ) Question: Head Rush |
|---|---|
| Description | Nicotine Effects Questionnaire (NEQ) question: feels head rush. Score ranges from 0 to 100 with higher levels indicating feeling stronger/more intense head rush after smoking. |
| Time Frame | Day 1 (pre smoking session), Day 5 (post smoking session) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Some data is missing due to participants missing/skipping visits or from withdrawing or being withdrawn from the study. |
| Arm/Group Title | Progesterone 200 mg Capsules | Progesterone 200 mg Look-alike Capsules |
|---|---|---|
| Arm/Group Description | Subjects will be prescribed progesterone 200 mg capsules by the study Principal Investigator. Subjects will take 200 mg of progesterone daily for four days. Progesterone: Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone. | Subjects will be prescribed progesterone 200 mg look-alike placebo capsules by the study Principal Investigator. Subjects will take look-alike placebo capsules daily for four days. Placebo: Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo. |
| Measure Participants | 66 | 66 |
| Day 1; pre-1st smoking session |
30.58
(4.65)
|
29.38
(4.59)
|
| Day 5; after smoking |
40.23
(4.71)
|
42.48
(5.01)
|
Adverse Events
| Time Frame | Adverse event data was collected during the duration of the study (2-3 months from first visit in phase 1 to final visit in phase 2 of crossover design) | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | Progesterone 200 mg Look-alike Capsules | Progesterone 200 mg Capsules | ||
| Arm/Group Description | This arm includes all phases when participants were received placebo (phase 1/week 1 for participants randomized to receive placebo first; phase 2/week 2 for participants randomized to receive placebo second) | This arm includes all phases when participants were received progesterone (phase 1/week 1 for participants randomized to receive progesterone first; phase 2/week 2 for participants randomized to receive progesterone second) | ||
All Cause Mortality |
||||
| Progesterone 200 mg Look-alike Capsules | Progesterone 200 mg Capsules | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/66 (0%) | 0/66 (0%) | ||
Serious Adverse Events |
||||
| Progesterone 200 mg Look-alike Capsules | Progesterone 200 mg Capsules | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/66 (0%) | 0/66 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| Progesterone 200 mg Look-alike Capsules | Progesterone 200 mg Capsules | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 54/66 (81.8%) | 56/66 (84.8%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 7/66 (10.6%) | 7 | 6/66 (9.1%) | 6 |
| General disorders | ||||
| Other adverse event | 47/66 (71.2%) | 117 | 47/66 (71.2%) | 107 |
| Nervous system disorders | ||||
| Headache | 16/66 (24.2%) | 18 | 12/66 (18.2%) | 13 |
| Dizziness | 4/66 (6.1%) | 4 | 3/66 (4.5%) | 3 |
| Lightheadedness | 2/66 (3%) | 2 | 1/66 (1.5%) | 1 |
| Psychiatric disorders | ||||
| Irritability | 30/66 (45.5%) | 39 | 27/66 (40.9%) | 37 |
| Insomnia | 8/66 (12.1%) | 10 | 3/66 (4.5%) | 3 |
| Hypersomnia | 3/66 (4.5%) | 3 | 5/66 (7.6%) | 9 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Claudia Iannelli |
|---|---|
| Organization | University of Pennsylvania |
| Phone | 6104424426 |
| Claudia.iannelli@pennmedicine.upenn.edu |
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01954966
Other Study ID Numbers:
- 811940
- K24DA030301
First Posted:
Oct 7, 2013
Last Update Posted:
Jul 5, 2022
Last Verified:
Jun 1, 2022