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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
97
Duke Center for Smoking Cessation
Durham, North Carolina, United States
Time-to-lapse
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
Smoking Withdrawal
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
Number of Participants Reporting Smoking Abstinence
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
Number of Participants Reporting Tolerability Issues With Lorcaserin + Nicotine Patch Treatment
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
Weight Gain Following Continuous Four-week Abstinence From Smoking
Among smoking-abstinent participants, weight gain relative to baseline will be assessed.
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Time frame: Week 10 post quit day
Number of Participants Reporting 6-month Smoking Abstinence
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
Percentage of Change in Ad Libitum Smoking at End of Week 2
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
Adherence to Lorcaserin + Nicotine Patch Treatment as Indicator of Tolerability
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