Trial Outcomes & Findings for Combination Nicotine Patch / Lorcaserin for Smoking Cessation (NCT NCT02906644)
NCT ID: NCT02906644
Last Updated: 2019-05-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
97 participants
Primary outcome timeframe
Week 2 pre quit day
Results posted on
2019-05-07
Participant Flow
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.
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 enrolled, 36 were withdrawn by study staff or withdrew voluntarily from further participation prior to the 1st study visit (V1): 14 did not meet inclusion criteria, 16 met exclusion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.
Participant milestones
| Measure |
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.
lorcaserin
nicotine patch
|
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
|
|---|---|---|
|
First 2 Weeks
STARTED
|
31
|
30
|
|
First 2 Weeks
COMPLETED
|
30
|
27
|
|
First 2 Weeks
NOT COMPLETED
|
1
|
3
|
|
Weeks 3 to 14
STARTED
|
30
|
27
|
|
Weeks 3 to 14
Final Study Visit
|
17
|
20
|
|
Weeks 3 to 14
Follow-up (6 Months Post Quit Day)
|
14
|
16
|
|
Weeks 3 to 14
COMPLETED
|
14
|
16
|
|
Weeks 3 to 14
NOT COMPLETED
|
16
|
11
|
Reasons for withdrawal
| Measure |
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.
lorcaserin
nicotine patch
|
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
|
|---|---|---|
|
First 2 Weeks
Withdrawal by Subject
|
0
|
2
|
|
First 2 Weeks
Physician Decision
|
1
|
1
|
|
Weeks 3 to 14
Withdrawal by Subject
|
13
|
7
|
|
Weeks 3 to 14
Lost to Follow-up
|
3
|
4
|
Baseline Characteristics
Combination Nicotine Patch / Lorcaserin for Smoking Cessation
Baseline characteristics by cohort
| Measure |
Lorcaserin + Patch
n=31 Participants
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
|
Patch
n=30 Participants
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
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
n=5 Participants
|
50 years
n=7 Participants
|
49 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 2 pre quit dayPopulation: 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.
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.
Outcome measures
| Measure |
Lorcaserin + Patch
n=29 Participants
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
|
Patch
n=25 Participants
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
|
|---|---|---|
|
Time-to-lapse
|
51.97 Minutes
Standard Deviation 18.331
|
56.44 Minutes
Standard Deviation 12.490
|
PRIMARY outcome
Timeframe: Week 2 pre quit dayPopulation: 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.
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.
Outcome measures
| Measure |
Lorcaserin + Patch
n=28 Participants
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
|
Patch
n=25 Participants
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
|
|---|---|---|
|
Smoking Withdrawal
Craving
|
2.81 score on a scale
Standard Deviation 1.271
|
2.91 score on a scale
Standard Deviation 1.219
|
|
Smoking Withdrawal
Negative Affect
|
2.15 score on a scale
Standard Deviation 0.788
|
2.21 score on a scale
Standard Deviation 0.937
|
|
Smoking Withdrawal
Arousal
|
4.73 score on a scale
Standard Deviation 1.014
|
4.72 score on a scale
Standard Deviation 1.251
|
|
Smoking Withdrawal
Appetite
|
3.11 score on a scale
Standard Deviation 1.685
|
2.80 score on a scale
Standard Deviation 1.607
|
SECONDARY outcome
Timeframe: Weeks 7-10 post quit dayNumber of participants who reported continuous four-week abstinence from smoking (weeks 7-10 post target quit date), confirmed by expired air carbon monoxide (CO).
Outcome measures
| Measure |
Lorcaserin + Patch
n=31 Participants
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
|
Patch
n=30 Participants
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
|
|---|---|---|
|
Number of Participants Reporting Smoking Abstinence
|
9 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Two Weeks pre and 10 weeks post quit dayPopulation: 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.
Tolerability of the lorcaserin + nicotine patch treatment will be assessed by tabulating the number of participants rating side effects \> "moderate".
Outcome measures
| Measure |
Lorcaserin + Patch
n=49 Participants
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
|
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
|
|---|---|---|
|
Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment
|
26 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 10 post quit dayPopulation: 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).
Among smoking-abstinent participants, weight gain relative to baseline will be assessed.
Outcome measures
| Measure |
Lorcaserin + Patch
n=19 Participants
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
|
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
|
|---|---|---|
|
Weight Gain Following Continuous Four-week Abstinence From Smoking
|
-0.35 weight gain (in lbs)
Standard Deviation 7.203
|
—
|
SECONDARY outcome
Timeframe: 6 months post Quit DayPopulation: 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).
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).
Outcome measures
| Measure |
Lorcaserin + Patch
n=61 Participants
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
|
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
|
|---|---|---|
|
Number of Participants Reporting 6-month Smoking Abstinence
|
9 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 2 pre quit dayPopulation: 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.
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.
Outcome measures
| Measure |
Lorcaserin + Patch
n=22 Participants
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
|
Patch
n=22 Participants
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
|
|---|---|---|
|
Percentage of Change in Ad Libitum Smoking at End of Week 2
|
-35.58 percentage of change
Standard Deviation 0.396
|
-47.13 percentage of change
Standard Deviation 0.482
|
SECONDARY outcome
Timeframe: Two Weeks pre and 10 weeks post quit dayPopulation: 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.
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.
Outcome measures
| Measure |
Lorcaserin + Patch
n=47 Participants
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
|
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
|
|---|---|---|
|
Adherence to Lorcaserin + Nicotine Patch Treatment as Indicator of Tolerability
|
72.15 percentage of days using study drugs
Standard Deviation 0.339
|
—
|
Adverse Events
Lorcaserin + Patch
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Patch (1st 2 Weeks)
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lorcaserin + Patch
n=56 participants at risk
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
|
Patch (1st 2 Weeks)
n=27 participants at risk
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
|
|---|---|---|
|
General disorders
Somnambulism
|
0.00%
0/56 • 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.
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).
|
3.7%
1/27 • Number of events 1 • 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.
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).
|
Other adverse events
| Measure |
Lorcaserin + Patch
n=56 participants at risk
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
|
Patch (1st 2 Weeks)
n=27 participants at risk
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
|
|---|---|---|
|
General disorders
Fatigue
|
21.4%
12/56 • Number of events 14 • 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.
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).
|
7.4%
2/27 • Number of events 2 • 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.
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).
|
|
General disorders
Dizziness/Lightheadedness
|
5.4%
3/56 • Number of events 3 • 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.
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).
|
0.00%
0/27 • 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.
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).
|
|
General disorders
Insomnia
|
7.1%
4/56 • Number of events 5 • 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.
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).
|
3.7%
1/27 • Number of events 1 • 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.
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).
|
|
General disorders
Vivid Dreams
|
35.7%
20/56 • Number of events 27 • 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.
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).
|
33.3%
9/27 • Number of events 9 • 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.
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).
|
|
General disorders
Dry Mouth
|
12.5%
7/56 • Number of events 13 • 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.
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).
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0.00%
0/27 • 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.
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).
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General disorders
Coughing
|
8.9%
5/56 • Number of events 8 • 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.
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).
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7.4%
2/27 • Number of events 2 • 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.
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).
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Gastrointestinal disorders
Nausea
|
5.4%
3/56 • Number of events 3 • 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.
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).
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0.00%
0/27 • 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.
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).
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Gastrointestinal disorders
Constipation
|
8.9%
5/56 • Number of events 9 • 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.
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).
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0.00%
0/27 • 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.
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).
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Skin and subcutaneous tissue disorders
Itching at Patch Site
|
23.2%
13/56 • Number of events 25 • 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.
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).
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14.8%
4/27 • Number of events 4 • 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.
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).
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Skin and subcutaneous tissue disorders
Rash at Patch Site
|
8.9%
5/56 • Number of events 11 • 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.
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).
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0.00%
0/27 • 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.
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).
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place