Some individuals smoke with the perception that smoking helps control body weight. Smokers gain an average of as much as 10 pounds in the months following smoking abstinence, with heavier and more-dependent smokers gaining more weight. T The Mayo Clinic Nicotine Research Program will randomize 100 nondiabetic, overweight or obese adult smokers to active lorcaserin or placebo for 24 weeks; all of the subjects will receive open-label varenicline for 12 weeks. The purpose of this study is to assess the efficacy of a 24-week course of lorcaserin for decreasing weight gain after stopping smoking.
This will be a randomized, placebo-controlled, parallel-group clinical trial. Nondiabetic, overweight and obese adult smokers will be randomized to one of three arms: * lorcaserin for 24 weeks in combination with varenicline for 12 weeks; * placebo for 24 weeks in combination with varenicline for 12 weeks; We will assess the following: * changes in weight and Weight Concern * 7-day point-prevalence smoking abstinence weekly through week 24 and prolonged smoking abstinence at 24 and 52 weeks. Subjects will have a target quit date 8 days after starting medication.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
84
lorcaserin is an FDA-approved weight loss medication for overweight and obese patients
Chantix is an FDA approved medication for smoking cessation
Placebo for lorcaserin
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Post Cessation Weight Gain (kg)
weight (kg) change from baseline to week 24 among subjects who meet criteria for prolonged smoking abstinence at week 24
Time frame: 24 weeks
BMI
BMI change from baseline to week 24
Time frame: 24 weeks
Smoking Abstinence
Lorcaserin combined with open label varenicline will be evaluated for improved smoking abstinence compared to placebo
Time frame: 24 weeks
Waist Circumference
Waist Circumference change from baseline to week 24
Time frame: 24 weeks
Fat Mass
Body Fat difference from baseline to week 24.
Time frame: 24 weeks
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