Combination Nicotine Patch / Lorcaserin for Smoking Cessation (LorNic)
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|ClinicalTrials.gov Identifier: NCT02906644|
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : November 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Nicotine Dependence||Drug: lorcaserin Drug: nicotine patch Drug: placebo lorcaserin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Combination Nicotine Patch / Lorcaserin for Smoking Cessation|
|Actual Study Start Date :||November 8, 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
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.
Other Name: BelviqDrug: nicotine patch
Other Name: Nicoderm
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.
Other Name: BelviqDrug: nicotine patch
Other Name: NicodermDrug: placebo lorcaserin
Other Name: placebo Belviq
- Time-to-lapse [ Time Frame: 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 [ Time Frame: 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 questionnaire, which consists of 33-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 33 items are grouped into 8 subscales: Craving, Negative Affect, Appetite, Arousal, Somatic - Anxiety, Somatic - G.I., Somatic - Respiratory Tract, and Habit Withdrawal. The range of scores for each subscale will be 1-7, with higher scores indicating more of the withdrawal symptom having been experienced.
- Smoking Abstinence [ Time Frame: 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).
- Tolerability [ Time Frame: Weeks 1-10 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 [ Time Frame: Week 10 post quit day ]Among smoking-abstinent participants, weight gain relative to baseline will be assessed.
- 6-month Smoking Abstinence [ Time Frame: 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 [ Time Frame: Week 2 pre quit day ]To evaluate the effects of lorcaserin on ad libitum (ad lib) smoking, the percent decrease 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 [ Time Frame: Weeks 1-10 post quit day ]Tolerability of the lorcaserin + nicotine patch treatment will be assessed by calculating adherence scores based on the number of days on which the study drugs were taken as directed between visits as reported by participants on diaries.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02906644
|Contact: Al Salleyfirstname.lastname@example.org|
|Contact: Susan Claerhout, P.A.-Cemail@example.com|
|United States, North Carolina|
|Duke Center for Smoking Cessation||Recruiting|
|Durham, North Carolina, United States, 27705|
|Contact: Jed Rose, Ph.D. 919-668-5055|
|Principal Investigator:||Jed E. Rose, Ph.D.||Duke University|