ConNicBrain: Mechanistic Evaluations of Pre-Cessation Therapies for Smoking Cessation
Study Details
Study Description
Brief Summary
The purpose of this study is to look at brain function in order to understand how different treatments work to help people quit smoking. In this study, the investigators will look at the effects of nicotine patches, Chantix alone or Chantix paired with Zyban.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: varenicline For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches. |
Drug: Varenicline
Other Names:
Drug: Nicotine patches
Other Names:
Other: Placebo bupropion
Other: Placebo patch
|
| Active Comparator: NRT (nicotine patches only) 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. |
Drug: Nicotine patches
Other Names:
Other: Placebo varenicline
Other: Placebo bupropion
|
| Active Comparator: varenicline + bupropion For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches. |
Drug: Varenicline
Other Names:
Drug: Bupropion
Other Names:
Drug: Nicotine patches
Other Names:
Other: Placebo patch
|
| Placebo Comparator: Post-quit NRT Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. |
Drug: Nicotine patches
Other Names:
Other: Placebo varenicline
Other: Placebo bupropion
Other: Placebo patch
|
Outcome Measures
Primary Outcome Measures
- The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences [change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) images collected during a cue-reactivity task following 2 weeks of pre-quit treatment]
Mean blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) cue-reactivity signal following 2 week pre-quit treatment, controlling for baseline cue-reactivity.
Secondary Outcome Measures
- Days to First Cigarette Following Quitting Smoking [Up to 11 weeks post quit day.]
Days to first cigarette (i.e. lapse) will be measured via self-report.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Are generally healthy;
-
Are 18-50 years old;
-
Smoke an average of at least 10 cigarettes per day for at least three cumulative years;
-
Have an afternoon expired air carbon monoxide (CO) reading of at least 10ppm;
-
Are right-handed as measured by a two-item scale used in our laboratory;
-
Express a desire to quit smoking in the next thirty days.
-
Potential subjects must agree to use acceptable contraception during their participation in this study.
Potential subjects must agree to avoid the following during their participation in this study:
-
participation in any other nicotine-related modification strategy outside of this protocol;
-
use of tobacco products other than cigarettes, including pipe tobacco, cigars, e-cigarettes, snuff, and chewing tobacco;
-
use of experimental (investigational) drugs or devices;
-
use of illegal drugs;
-
use of opiate medications.
Exclusion Criteria:
-
Inability to attend all required experimental sessions;
-
Presence of conditions that would make MRI unsafe (e.g. pacemaker);
-
Hypertension (systolic >140 mm Hg, diastolic >100 mm Hg, coupled with a history of hypertension); subjects with no previous diagnosis of hypertension may have a screening blood pressure up to 160/100.
-
Hypotension with symptoms (systolic <90 mm Hg, diastolic <60 mm Hg).
-
Coronary heart disease;
-
Lifetime history of heart attack;
-
Cardiac rhythm disorder (irregular heart rhythm);
-
Chest pains (unless history, exam, and ECG clearly indicate a non-cardiac source);
-
Cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
-
History of skin allergy;
-
Active skin disorder (e.g., psoriasis) within the last five years, except minor skin conditions (including but not limited to facial acne, minor localized infections, and superficial minor wounds);
-
Liver or kidney disorder (except kidney stones, gallstones);
-
Gastrointestinal problems or disease other than gastroesophageal reflux or heartburn;
-
Active ulcers in the past 30 days;
-
Lung disorder (including but not limited to Chronic obstructive pulmonary disease (COPD), emphysema, and asthma);
-
Brain abnormality (including but not limited to stroke, brain tumor, and seizure disorder);
-
Migraine headaches that occur more frequently than once per week;
-
Recent, unexplained fainting spells;
-
Problems giving blood samples;
-
Diabetes;
-
Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
-
Other major medical condition;
-
Current psychiatric disease (with the exception of anxiety disorders, Obsessive-compulsive disorder (OCD) and Attention deficit hyperactivity disorder (ADHD));
-
Bulimia or anorexia;
-
Suicidal ideation (within the past 10 years) or lifetime occurrence of attempted suicide;
-
Current depression;
-
Pregnant or nursing mothers;
-
Alcohol abuse;
-
Significant adverse reaction to nicotine patch, bupropion/Wellbutrin/Zyban or Chantix/Varenicline in the past.
-
Use (within the past 30 days) of:
-
Illegal drugs (or if the urine drug screen is positive);
-
Experimental (investigational) drugs;
-
Psychiatric medications including antidepressants, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
-
Smokeless tobacco (chewing tobacco, snuff), cigars or pipes;
-
Nicotine replacement therapy or any other smoking cessation aid.
-
Use (within the past 14 days) of:
-
Opiate medications for pain or sleep (non-opiate medication for pain or sleep will be allowed).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke Center for Nicotine and Smoking Cessation Research | Durham | North Carolina | United States | 27705 |
| 2 | Duke Center for Nicotine and Smoking Cessation Research | Raleigh | North Carolina | United States | 27609 |
Sponsors and Collaborators
- Duke University
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: F. Joseph McClernon, Ph.D., Duke University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00028331
- 1P50DA027840-01A1
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail | Of the 282 participants who were consented and screened, 191 were screen fails, 2 withdrew voluntarily before being assigned to a study arm, and 13 were lost to contact between screening and the first study visit. Therefore, only 76 participants were randomized and started the study. |
| Arm/Group Title | Varenicline | NRT (Nicotine Patches Only) | Varenicline + Bupropion | Post-quit NRT |
|---|---|---|---|---|
| Arm/Group Description | For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches. Varenicline Nicotine patches Placebo bupropion Placebo patch | 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. Nicotine patches Placebo varenicline Placebo bupropion | For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches. Varenicline Bupropion Nicotine patches Placebo patch | Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. Nicotine patches Placebo varenicline Placebo bupropion Placebo patch |
| Period Title: Overall Study | ||||
| STARTED | 18 | 19 | 20 | 19 |
| COMPLETED | 6 | 7 | 2 | 3 |
| NOT COMPLETED | 12 | 12 | 18 | 16 |
Baseline Characteristics
| Arm/Group Title | Varenicline | NRT (Nicotine Patches Only) | Varenicline + Bupropion | Post-quit NRT | Total |
|---|---|---|---|---|---|
| Arm/Group Description | For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches. Varenicline Nicotine patches Placebo bupropion Placebo patch | 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. Nicotine patches Placebo varenicline Placebo bupropion | For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches. Varenicline Bupropion Nicotine patches Placebo patch | Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. Nicotine patches Placebo varenicline Placebo bupropion Placebo patch | Total of all reporting groups |
| Overall Participants | 18 | 19 | 20 | 19 | 76 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
18
100%
|
18
94.7%
|
20
100%
|
19
100%
|
75
98.7%
|
| >=65 years |
0
0%
|
1
5.3%
|
0
0%
|
0
0%
|
1
1.3%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
37.56
(10.68)
|
41.89
(12.22)
|
38.35
(11.42)
|
37.16
(10.59)
|
38.75
(11.19)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
11
61.1%
|
11
57.9%
|
8
40%
|
10
52.6%
|
40
52.6%
|
| Male |
7
38.9%
|
8
42.1%
|
12
60%
|
9
47.4%
|
36
47.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
2
11.1%
|
1
5.3%
|
2
10%
|
0
0%
|
5
6.6%
|
| Not Hispanic or Latino |
16
88.9%
|
18
94.7%
|
18
90%
|
19
100%
|
71
93.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
1
5.3%
|
0
0%
|
0
0%
|
1
1.3%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
12
66.7%
|
6
31.6%
|
9
45%
|
7
36.8%
|
34
44.7%
|
| White |
5
27.8%
|
11
57.9%
|
10
50%
|
12
63.2%
|
38
50%
|
| More than one race |
1
5.6%
|
1
5.3%
|
1
5%
|
0
0%
|
3
3.9%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (participants) [Number] | |||||
| United States |
18
100%
|
19
100%
|
20
100%
|
19
100%
|
76
100%
|
Outcome Measures
| Title | The Amygdala, Anterior Insula, and Medial Prefrontal Cortex Scans Will be Compared to Evaluate Significant Differences |
|---|---|
| Description | Mean blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) cue-reactivity signal following 2 week pre-quit treatment, controlling for baseline cue-reactivity. |
| Time Frame | change from baseline in whole brain blood-oxygen-level dependent (BOLD) contrast sensitive functional magnetic resonance imaging (fMRI) images collected during a cue-reactivity task following 2 weeks of pre-quit treatment |
Outcome Measure Data
| Analysis Population Description |
|---|
| Only participants who completed both scanning sessions and provided useable data were included in imaging analysis. |
| Arm/Group Title | Varenicline | NRT (Nicotine Patches Only) | Varenicline + Bupropion | Post-quit NRT |
|---|---|---|---|---|
| Arm/Group Description | For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches. Varenicline Nicotine patches Placebo bupropion Placebo patch | 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. Nicotine patches Placebo varenicline Placebo bupropion | For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches. Varenicline Bupropion Nicotine patches Placebo patch | Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. Nicotine patches Placebo varenicline Placebo bupropion Placebo patch |
| Measure Participants | 10 | 13 | 8 | 8 |
| left amygdala |
0.057
(0.285)
|
.007
(.186)
|
.160
(.258)
|
.129
(.278)
|
| right amydala |
.051
(.337)
|
-.014
(.190)
|
.134
(.266)
|
.020
(.249)
|
| left anterior insula |
.094
(.196)
|
.013
(.244)
|
-.015
(.160)
|
.179
(.288)
|
| right anterior insula |
-.008
(.224)
|
.065
(.305)
|
.019
(.188)
|
.082
(.333)
|
| left medial prefrontal cortex |
.129
(.162)
|
.026
(.294)
|
-.120
(.562)
|
.009
(.200)
|
| right medial prefrtonal cortex |
.058
(.171)
|
-.010
(.277)
|
-.176
(.641)
|
-.017
(.178)
|
| Title | Days to First Cigarette Following Quitting Smoking |
|---|---|
| Description | Days to first cigarette (i.e. lapse) will be measured via self-report. |
| Time Frame | Up to 11 weeks post quit day. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Twenty-eight subjects dropped from the study prior to their scheduled quit day, so they were not included in these analyses. |
| Arm/Group Title | Varenicline | NRT (Nicotine Patches Only) | Varenicline + Bupropion | Post-quit NRT |
|---|---|---|---|---|
| Arm/Group Description | For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches. Varenicline Nicotine patches Placebo bupropion Placebo patch | 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. Nicotine patches Placebo varenicline Placebo bupropion | For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches. Varenicline Bupropion Nicotine patches Placebo patch | Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. Nicotine patches Placebo varenicline Placebo bupropion Placebo patch |
| Measure Participants | 13 | 14 | 10 | 11 |
| Mean (Standard Deviation) [days] |
9.15
(22.143)
|
15.21
(26.066)
|
9.90
(23.960)
|
5.73
(18.666)
|
Adverse Events
| Time Frame | Subjects were receiving study drugs for 13 weeks. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | At each study session during this period subjects completed a questionnaire about side effects. Subjects were also told to contact us between study sessions if side effects were bothersome. | |||||||
| Arm/Group Title | Varenicline | NRT (Nicotine Patches Only) | Varenicline + Bupropion | Post-quit NRT | ||||
| Arm/Group Description | For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline, smokers in this group will also receive placebo bupropion and placebo patches. Varenicline Nicotine patches Placebo bupropion Placebo patch | 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. Nicotine patches Placebo varenicline Placebo bupropion | For the first 3 days after being switched from Nicotine Replacement Therapy (NRT) occurring at one week before the target quit date, smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus bupropion at a dose of 150mg once per day. Subsequently, the dose of varenicline will be 1 mg twice per day and the dose of bupropion will be 150 mg twice per day, and will remain at that dose for the remainder of the 12 weeks. During the time they receive varenicline and bupropion, smokers in this group will also receive placebo patches. Varenicline Bupropion Nicotine patches Placebo patch | Nicotine patches at 21 mg/24 h for 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks. After the 1st week, smokers in this group will also receive placebo bupropion and placebo varenicline. Nicotine patches Placebo varenicline Placebo bupropion Placebo patch | ||||
All Cause Mortality |
||||||||
| Varenicline | NRT (Nicotine Patches Only) | Varenicline + Bupropion | Post-quit NRT | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| Varenicline | NRT (Nicotine Patches Only) | Varenicline + Bupropion | Post-quit NRT | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/18 (0%) | 0/19 (0%) | 0/20 (0%) | 0/19 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Varenicline | NRT (Nicotine Patches Only) | Varenicline + Bupropion | Post-quit NRT | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/18 (16.7%) | 6/19 (31.6%) | 6/20 (30%) | 4/19 (21.1%) | ||||
| Gastrointestinal disorders | ||||||||
| Heartburn | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/20 (0%) | 0 | 0/19 (0%) | 0 |
| Nausea | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/20 (0%) | 0 | 1/19 (5.3%) | 1 |
| Constipation | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/20 (0%) | 0 | 0/19 (0%) | 0 |
| Upset Stomach | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 0/20 (0%) | 0 | 0/19 (0%) | 0 |
| General disorders | ||||||||
| Dry Mouth | 0/18 (0%) | 0 | 2/19 (10.5%) | 7 | 1/20 (5%) | 1 | 2/19 (10.5%) | 3 |
| Thirst | 0/18 (0%) | 0 | 2/19 (10.5%) | 7 | 0/20 (0%) | 0 | 3/19 (15.8%) | 5 |
| Hiccups | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/20 (0%) | 0 | 0/19 (0%) | 0 |
| Decreased Libido | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 1/20 (5%) | 1 | 0/19 (0%) | 0 |
| Mouth/Throat Irritation | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/20 (0%) | 0 | 1/19 (5.3%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||||
| Joint/Muscle Pain | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/20 (0%) | 0 | 3/19 (15.8%) | 7 |
| Nervous system disorders | ||||||||
| Headache | 1/18 (5.6%) | 1 | 0/19 (0%) | 0 | 2/20 (10%) | 2 | 2/19 (10.5%) | 3 |
| Excessive Sweating | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/20 (0%) | 0 | 0/19 (0%) | 0 |
| Irritability | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 3/20 (15%) | 3 | 1/19 (5.3%) | 1 |
| Nightmares | 0/18 (0%) | 0 | 0/19 (0%) | 0 | 0/20 (0%) | 0 | 1/19 (5.3%) | 3 |
| Vivid Dreams | 2/18 (11.1%) | 3 | 1/19 (5.3%) | 1 | 3/20 (15%) | 6 | 3/19 (15.8%) | 6 |
| Insomnia | 1/18 (5.6%) | 2 | 1/19 (5.3%) | 1 | 0/20 (0%) | 0 | 3/19 (15.8%) | 9 |
| Psychiatric disorders | ||||||||
| Depression | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/20 (0%) | 0 | 0/19 (0%) | 0 |
| Anxiety | 0/18 (0%) | 0 | 1/19 (5.3%) | 1 | 0/20 (0%) | 0 | 0/19 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Coughing | 2/18 (11.1%) | 4 | 2/19 (10.5%) | 2 | 3/20 (15%) | 3 | 1/19 (5.3%) | 2 |
| Skin and subcutaneous tissue disorders | ||||||||
| Itching/Burning at Patch Site | 1/18 (5.6%) | 1 | 1/19 (5.3%) | 2 | 0/20 (0%) | 0 | 0/19 (0%) | 0 |
| Rash at Patch Site | 0/18 (0%) | 0 | 1/19 (5.3%) | 2 | 0/20 (0%) | 0 | 0/19 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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 | Principal Investigator |
|---|---|
| Organization | Duke University Medical Center |
| Phone | 919-668-3987 |
| francis.mcclernon@duke.edu |
- Pro00028331
- 1P50DA027840-01A1