Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial

OBJECTIVE: To evaluate the safety and effectiveness of combination varenicline with lorcaserin in preventing post-cessation weight gain. PARTICIPANTS AND METHODS: We conducted a randomized (varenicline for 12 weeks + lorcaserin for 24 weeks vs varenicline for 12 weeks + placebo for 24 weeks) phase II clinical study to obtain preliminary data on the safety and effectiveness of combination varenicline and lorcaserin in preventing post-cessation weight gain in overweight and obese smokers. Eighty-four overweight and obese (body mass index [BMI], 27-40 kg/m(2)) cigarette smokers were randomized before study termination (lorcaserin: n=40; placebo: n=44). The primary outcomes were weight and waist circumference (WC) changes at 12 and 24 weeks in smokers meeting criteria for prolonged smoking abstinence. RESULTS: Thirty-nine participants met criteria for prolonged smoking abstinence at 12 weeks (46%) and 21 at 24 weeks (25%). No significant treatment effect was observed at 12 weeks with lorcaserin compared with placebo (weight difference, −0.7 kg; 90% CI, −2.6 to 1.1 kg; P=.51; WC difference, −1.9 cm; 90% CI, −4.2 to 0.5 cm; P=.18; or BMI difference, −0.4 kg/m(2); 90% CI, −1.1 to 0.3 kg/m(2); P=.33). No significant treatment effect was observed between lorcaserin at 24 weeks compared with placebo (weight, 1.4 kg; 90% CI, −3.8 to 6.7 kg; P=.65; WC, −0.9 cm; 90% CI, −5.8 to 4.0 cm; P=.75; or BMI 0.29 kg/m(2); 90% CI, −1.5 to 2.12 kg/m(2); P=.79). CONCLUSION: Weight gain and WC increases after prolonged smoking abstinence were not reduced using combination varenicline and lorcaserin. The results do not support further research in the obese and weight-concerned smoking population using lorcaserin or similar drugs. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02412631