LorNic: Combination Nicotine Patch / Lorcaserin for Smoking Cessation
Study Details
Study Description
Brief Summary
This study plans to compare the efficacy of the nicotine patch / lorcaserin combination treatment vs. the nicotine patch alone in terms of leading to a reduction in smoking behavior and withdrawal symptoms.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
This study proposes to investigate the potential efficacy of a combination of two FDA-approved agents, nicotine patch and lorcaserin, for smoking cessation treatment. The nicotine patch which provides a sustained low dose of nicotine is a nicotine receptor agonist. Lorcaserin, a serotonin 5-hydroxytryptamine receptor 2C (5-HT2C) agonist, is a drug that is FDA-approved for weight loss, and has also recently been shown to be efficacious for smoking cessation. Given that these drugs act through distinct mechanisms it is hoped that the combination will prove more efficacious than either drug alone. It is also hypothesized that the combination will reduce weight gain commonly seen after smoking cessation.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Lorcaserin + Patch Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. |
Drug: lorcaserin
Other Names:
Drug: nicotine patch
Other Names:
|
| Experimental: Patch Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. |
Drug: lorcaserin
Other Names:
Drug: nicotine patch
Other Names:
Drug: placebo lorcaserin
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Time-to-lapse [Week 2 pre quit day]
Two weeks after treatment is initiated, with nicotine patch + lorcaserin or nicotine patch alone, but still two weeks prior to the quit day, subjects will be evaluated in a modified version of the McKee Smoking Lapse Task. In this task smokers, who have been abstinent for 2 hours will be provided with the option to smoke at any time, but paid by the minute for remaining abstinent with progressively decreasing payments over an hour.
- Smoking Withdrawal [Week 2 pre quit day]
At the study visit above (two week post treatment initiation but 2 weeks prior to quit day), withdrawal symptoms will be assessed after 2 hours of smoking abstinence using the Shiffman-Jarvik (short form) questionnaire, which consists of 9 items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 9 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, and Arousal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
Secondary Outcome Measures
- Number of Participants Reporting Smoking Abstinence [Weeks 7-10 post quit day]
Number of participants who reported continuous four-week abstinence from smoking (weeks 7-10 post target quit date), confirmed by expired air carbon monoxide (CO).
- Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment [Two Weeks pre and 10 weeks post quit day]
Tolerability of the lorcaserin + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > "moderate".
- Weight Gain Following Continuous Four-week Abstinence From Smoking [Week 10 post quit day]
Among smoking-abstinent participants, weight gain relative to baseline will be assessed.
- Number of Participants Reporting 6-month Smoking Abstinence [6 months post Quit Day]
Number of participants who reported not smoking for the previous seven days when called for 6-month follow-up, confirmed by expired air carbon monoxide (CO).
- Percentage of Change in Ad Libitum Smoking at End of Week 2 [Week 2 pre quit day]
To evaluate the effects of lorcaserin on ad libitum (ad lib) smoking, the percent change in reported number of cigarettes smoked from baseline to the end of week 2 (the day prior to the 2nd study visit) will be calculated.
- Adherence to Lorcaserin + Nicotine Patch Treatment as Indicator of Tolerability [Two Weeks pre and 10 weeks post quit day]
Tolerability of the lorcaserin + nicotine patch treatment will be assessed by calculating adherence scores based on the percentage of days on which the study drugs were taken between visits as reported by participants on diaries.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
18-65 years old;
-
Smoke an average of at least 10 cigarettes per day;
-
Have smoked at least one cumulative year;
-
Have an expired air CO reading of at least 10ppm;
-
Body weight of >50 kg (110 lbs.)
-
Able to read and understand English;
-
Express a desire to quit smoking in the next thirty days.
Exclusion Criteria:
-
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).
-
Participants with a history of hypertension may, however, be allowed to participate in the study if the study physician or physician assistant determines that the condition is stable, controlled by medication, and in no way jeopardizes the individual's safety.
-
Coronary heart disease, diagnosed by coronary angiogram;
-
Lifetime history of heart attack;
-
Cardiac rhythm disorder (irregular heart rhythm);
-
Chest pain in the last month (unless history, exam, and ECG clearly indicate a non-cardiac source);
-
Symptomatic cardiac (heart) disorder (including but not limited to valvular heart disease, heart murmur, heart failure);
-
Diagnosis of liver disease or kidney disorder (except kidney stones, gallstones);
-
Gastrointestinal problems (e.g. Celiac disease, Crohn's dx Ulcerative Colitis) or disease other than gastroesophageal reflux or heartburn;
-
Active ulcers in the past 30 days;
-
Currently symptomatic lung disorder/disease (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 (unless controlled by diet and exercise alone and screening glucose is less than 180mg/dcl and HbA1c is less than 7%);
-
Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
-
HIV, Hepatitis B, or Hepatitis C
-
History of tuberculosis or recent positive purified protein derivative (PPD) test
-
Other major medical condition;
-
Current psychiatric disease (with the exception of anxiety disorders, obsessive compulsive disorder (OCD) and ADHD);
-
Suicidal ideating (thinking about ways to commit suicide) (within the past 10 years) or lifetime occurrence of attempted suicide;
-
Current depression - The Patient Health Questionnaire (PHQ-9) for Depression will be used to screen for current (within 2 weeks) depression. Potential subjects who score
9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
-
Bulimia or anorexia;
-
BMI of < 18.5 kg/m2;
-
Prior use of fenfluramine or dexfenfluramine
-
Use (within the past 30 days) of:
-
Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (PCP), Benzodiazepines, or Barbiturates), Unless recent use of prescription Opiates, Benzodiazepines for management of acute symptoms.
-
Experimental (investigational) drugs;
-
Psychiatric medications including antidepressants (selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), St. John's Wort), lithium, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
-
Phentermine, triptans, tryptophan, linezolid, dextromethorphan, opiates, tramadol, or dopamine agonists;
-
Any agents that have documented correlation with increased incidence of valvulopathy and/or pulmonary hypertension (e.g., cyproheptadine, trazodone, nefazodone, amoxapine, tricyclic antidepressants, mirtazapine, pergolide, ergotamine, methysergide) (or anticipated use during the study);
-
Smokeless tobacco (chewing tobacco, snuff), pipes or e-cigarettes;
-
Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy or any other smoking cessation aid.
-
Concurrent use of a serotonergic agent/combination associated with severe serotonin syndrome (within the past 30 days);
-
Use of cigar, cigarillos, pipe, Hookah, dissolvable nicotine, snuff, chewing tobacco more than once per month.
-
Use of e-cigarettes once per month or more.
-
Self-report of consuming 4 or more alcoholic drinks on 1 or more days per week;
-
Significant adverse reaction to lorcaserin or nicotine patch in the past.
-
Current participation or recent participation (in the past 30 days) in another smoking study at the investigators Center or another research facility.
-
Current participation in another research study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Duke Center for Smoking Cessation | Durham | North Carolina | United States | 27705 |
Sponsors and Collaborators
- Duke University
- National Institute on Drug Abuse (NIDA)
Investigators
- Principal Investigator: Jed E. Rose, Ph.D., Duke University
Study Documents (Full-Text)
More Information
Publications
None provided.- Pro00074741
- P50DA027840-06
Study Results
Participant Flow
| Recruitment Details | Recruitment began on 11/8/2016 and ended on 2/20/2018. Of the 97 subjects (subjs.) consented during this period, 61 subjects met all study criteria, attended the first study visit, were randomized and received study intervention. |
|---|---|
| Pre-assignment Detail | Of the 97 subjs. enrolled, 36 were withdrawn by study staff or withdrew voluntarily from further participation prior to the 1st study visit (V1): 14 did not meet inclusion criteria, 16 met exclusion criteria, 3 were unable to meet study requirements, 2 were excluded due to laboratory values, and 1 was excluded by the medical staff. |
| Arm/Group Title | Lorcaserin + Patch | Patch |
|---|---|---|
| Arm/Group Description | Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch | Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch placebo lorcaserin |
| Period Title: First 2 Weeks | ||
| STARTED | 31 | 30 |
| COMPLETED | 30 | 27 |
| NOT COMPLETED | 1 | 3 |
| Period Title: First 2 Weeks | ||
| STARTED | 30 | 27 |
| Final Study Visit | 17 | 20 |
| Follow-up (6 Months Post Quit Day) | 14 | 16 |
| COMPLETED | 14 | 16 |
| NOT COMPLETED | 16 | 11 |
Baseline Characteristics
| Arm/Group Title | Lorcaserin + Patch | Patch | Total |
|---|---|---|---|
| Arm/Group Description | Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch | Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch placebo lorcaserin | Total of all reporting groups |
| Overall Participants | 31 | 30 | 61 |
| Age (years) [Mean (Full Range) ] | |||
| Mean (Full Range) [years] |
47
|
50
|
49
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
24
77.4%
|
22
73.3%
|
46
75.4%
|
| Male |
7
22.6%
|
8
26.7%
|
15
24.6%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
12
38.7%
|
8
26.7%
|
20
32.8%
|
| White |
19
61.3%
|
21
70%
|
40
65.6%
|
| More than one race |
0
0%
|
1
3.3%
|
1
1.6%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||
| United States |
31
100%
|
30
100%
|
61
100%
|
Outcome Measures
| Title | Time-to-lapse |
|---|---|
| Description | Two weeks after treatment is initiated, with nicotine patch + lorcaserin or nicotine patch alone, but still two weeks prior to the quit day, subjects will be evaluated in a modified version of the McKee Smoking Lapse Task. In this task smokers, who have been abstinent for 2 hours will be provided with the option to smoke at any time, but paid by the minute for remaining abstinent with progressively decreasing payments over an hour. |
| Time Frame | Week 2 pre quit day |
Outcome Measure Data
| Analysis Population Description |
|---|
| Four participants dropped out of the study and 3 more reported having already quit smoking before the Smoking Lapse Task occurred; therefore, we have lapse data for only 54 participants rather than 61. |
| Arm/Group Title | Lorcaserin + Patch | Patch |
|---|---|---|
| Arm/Group Description | Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch | Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch placebo lorcaserin |
| Measure Participants | 29 | 25 |
| Mean (Standard Deviation) [Minutes] |
51.97
(18.331)
|
56.44
(12.490)
|
| Title | Smoking Withdrawal |
|---|---|
| Description | At the study visit above (two week post treatment initiation but 2 weeks prior to quit day), withdrawal symptoms will be assessed after 2 hours of smoking abstinence using the Shiffman-Jarvik (short form) questionnaire, which consists of 9 items rated from 1 to 7, where 1= not at all, 2= very little, 3= a little, 4= moderately, 5= a lot, 6= quite a lot, and 7= extremely. The 9 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, and Arousal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced. |
| Time Frame | Week 2 pre quit day |
Outcome Measure Data
| Analysis Population Description |
|---|
| Four participants dropped out of the study, 3 more reported having already quit smoking before the Smoking Lapse Task occurred, and 1 did not complete the withdrawal questionnaire; therefore, we have lapse data for only 53 participants rather than 61. |
| Arm/Group Title | Lorcaserin + Patch | Patch |
|---|---|---|
| Arm/Group Description | Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch | Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch placebo lorcaserin |
| Measure Participants | 28 | 25 |
| Craving |
2.81
(1.271)
|
2.91
(1.219)
|
| Negative Affect |
2.15
(0.788)
|
2.21
(0.937)
|
| Arousal |
4.73
(1.014)
|
4.72
(1.251)
|
| Appetite |
3.11
(1.685)
|
2.80
(1.607)
|
| Title | Number of Participants Reporting Smoking Abstinence |
|---|---|
| Description | Number of participants who reported continuous four-week abstinence from smoking (weeks 7-10 post target quit date), confirmed by expired air carbon monoxide (CO). |
| Time Frame | Weeks 7-10 post quit day |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Lorcaserin + Patch | Patch |
|---|---|---|
| Arm/Group Description | Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch | Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch placebo lorcaserin |
| Measure Participants | 31 | 30 |
| Count of Participants [Participants] |
9
29%
|
10
33.3%
|
| Title | Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment |
|---|---|
| Description | Tolerability of the lorcaserin + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects > "moderate". |
| Time Frame | Two Weeks pre and 10 weeks post quit day |
Outcome Measure Data
| Analysis Population Description |
|---|
| Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Twelve participants dropped out of the study prior to the next study visit, therefore side effects data from 2 weeks pre-quit to the end of the study are only available for 49 participants. |
| Arm/Group Title | Lorcaserin + Nicotine Patch |
|---|---|
| Arm/Group Description | All participants received active lorcaserin plus nicotine patches starting at Study Visit 2 (two weeks from baseline and two weeks prior to their quit day) after 2 weeks of receiving either active or placebo lorcaserin along with the nicotine patches. |
| Measure Participants | 49 |
| Count of Participants [Participants] |
26
83.9%
|
| Title | Weight Gain Following Continuous Four-week Abstinence From Smoking |
|---|---|
| Description | Among smoking-abstinent participants, weight gain relative to baseline will be assessed. |
| Time Frame | Week 10 post quit day |
Outcome Measure Data
| Analysis Population Description |
|---|
| Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Nineteen participants reported continuous four-week abstinence from smoking (weeks 7-10 post target quit date), confirmed by expired air carbon monoxide (CO). |
| Arm/Group Title | Lorcaserin + Nicotine Patch |
|---|---|
| Arm/Group Description | All participants received active lorcaserin plus nicotine patches starting at Study Visit 2 (two weeks from baseline and two weeks prior to their quit day) after 2 weeks of receiving either active or placebo lorcaserin along with the nicotine patches. |
| Measure Participants | 19 |
| Mean (Standard Deviation) [weight gain (in lbs)] |
-0.35
(7.203)
|
| Title | Number of Participants Reporting 6-month Smoking Abstinence |
|---|---|
| Description | Number of participants who reported not smoking for the previous seven days when called for 6-month follow-up, confirmed by expired air carbon monoxide (CO). |
| Time Frame | 6 months post Quit Day |
Outcome Measure Data
| Analysis Population Description |
|---|
| Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Nine participants reported continuous 7-day abstinence from smoking 6 months post quit-day, confirmed by expired air carbon monoxide (CO). |
| Arm/Group Title | Lorcaserin + Nicotine Patch |
|---|---|
| Arm/Group Description | All participants received active lorcaserin plus nicotine patches starting at Study Visit 2 (two weeks from baseline and two weeks prior to their quit day) after 2 weeks of receiving either active or placebo lorcaserin along with the nicotine patches. |
| Measure Participants | 61 |
| Count of Participants [Participants] |
9
29%
|
| Title | Percentage of Change in Ad Libitum Smoking at End of Week 2 |
|---|---|
| Description | To evaluate the effects of lorcaserin on ad libitum (ad lib) smoking, the percent change in reported number of cigarettes smoked from baseline to the end of week 2 (the day prior to the 2nd study visit) will be calculated. |
| Time Frame | Week 2 pre quit day |
Outcome Measure Data
| Analysis Population Description |
|---|
| There are insufficient data for 9 participants in the Lorcaserin + Patch group and for 8 participants in the Patch only group (due to participant dropout or incomplete or unreturned diaries) so this analysis excluded those individuals. |
| Arm/Group Title | Lorcaserin + Patch | Patch |
|---|---|---|
| Arm/Group Description | Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch | Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch placebo lorcaserin |
| Measure Participants | 22 | 22 |
| Mean (Standard Deviation) [percentage of change] |
-35.58
(0.396)
|
-47.13
(0.482)
|
| Title | Adherence to Lorcaserin + Nicotine Patch Treatment as Indicator of Tolerability |
|---|---|
| Description | Tolerability of the lorcaserin + nicotine patch treatment will be assessed by calculating adherence scores based on the percentage of days on which the study drugs were taken between visits as reported by participants on diaries. |
| Time Frame | Two Weeks pre and 10 weeks post quit day |
Outcome Measure Data
| Analysis Population Description |
|---|
| Two weeks pre-quit day, all study subjects were switched to taking active lorcaserin for the duration of the study. Fourteen subjects either dropped out prior to Visit 3 (the first visit after all subjects were on combined treatment) or had missing or incomplete diaries, so data are only available for 47 subjects during this phase of the study. |
| Arm/Group Title | Lorcaserin + Nicotine Patch |
|---|---|
| Arm/Group Description | All participants received active lorcaserin plus nicotine patches starting at Study Visit 2 (two weeks from baseline and two weeks prior to their quit day) after 2 weeks of receiving either active or placebo lorcaserin along with the nicotine patches. |
| Measure Participants | 47 |
| Mean (Standard Deviation) [percentage of days using study drugs] |
72.15
(0.339)
|
Adverse Events
| Time Frame | Subjects (subjs.) received (rcvd.) study drugs for 16 weeks. At each study session during this period subjs. completed a questionnaire (quest) about side effects (SE). Subjs. were also told to contact study staff between study sessions if SE were bothersome. | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | Serious Adverse Events (AE) and other AEs were evaluated for all subjs. who rcvd. nicotine patches and lorcaserin (31) or nicotine patches and placebo (30) at Visit (V) 1, & for all subjs. receiving nicotine patches and lorcaserin at V2 and subsequent visits (56) who completed side effects (SE) quest. Systematic evaluation of SE began at V2 after 2 weeks of study drug use (30 subjs. who had rcvd. nicotine patches and lorcaserin and 27 who had rcvd. nicotine patches and placebo). | |||
| Arm/Group Title | Lorcaserin + Patch | Patch (1st 2 Weeks) | ||
| Arm/Group Description | Participants will receive lorcaserin (10mg twice a day) and nicotine patches (21mg/24hr) for 14 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. Group 1 will receive this combined treatment throughout the study; Group 2 will receive the combined treatment after the first 2 weeks of receiving the nicotine patch only (with placebo lorcaserin). lorcaserin nicotine patch | Participants will receive nicotine patches (21mg/24hr) and placebo lorcaserin for 2 weeks; after 2 weeks participants will begin to receive active lorcaserin (10mg twice a day) along with the nicotine patches for 12 weeks, at which point the nicotine patch dosage will be reduced to 14mg/24hr for 1 week, followed by 7mg/24hr for 1 week. lorcaserin nicotine patch placebo lorcaserin | ||
All Cause Mortality |
||||
| Lorcaserin + Patch | Patch (1st 2 Weeks) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/56 (0%) | 0/27 (0%) | ||
Serious Adverse Events |
||||
| Lorcaserin + Patch | Patch (1st 2 Weeks) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/56 (0%) | 1/27 (3.7%) | ||
| General disorders | ||||
| Somnambulism | 0/56 (0%) | 0 | 1/27 (3.7%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| Lorcaserin + Patch | Patch (1st 2 Weeks) | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 35/56 (62.5%) | 12/27 (44.4%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 3/56 (5.4%) | 3 | 0/27 (0%) | 0 |
| Constipation | 5/56 (8.9%) | 9 | 0/27 (0%) | 0 |
| General disorders | ||||
| Fatigue | 12/56 (21.4%) | 14 | 2/27 (7.4%) | 2 |
| Dizziness/Lightheadedness | 3/56 (5.4%) | 3 | 0/27 (0%) | 0 |
| Insomnia | 4/56 (7.1%) | 5 | 1/27 (3.7%) | 1 |
| Vivid Dreams | 20/56 (35.7%) | 27 | 9/27 (33.3%) | 9 |
| Dry Mouth | 7/56 (12.5%) | 13 | 0/27 (0%) | 0 |
| Coughing | 5/56 (8.9%) | 8 | 2/27 (7.4%) | 2 |
| Skin and subcutaneous tissue disorders | ||||
| Itching at Patch Site | 13/56 (23.2%) | 25 | 4/27 (14.8%) | 4 |
| Rash at Patch Site | 5/56 (8.9%) | 11 | 0/27 (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 | Clinical Research Coordinator |
|---|---|
| Organization | Duke University |
| Phone | (919) 668-5055 |
| al.salley@duke.edu |
- Pro00074741
- P50DA027840-06