Addressing Post Cessation Weight Gain

Summary

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.

Timeline

Start

2016-06-15

Primary completion

2020-04-17

Completion

2020-04-17

Outcome

Missed primary endpoint

Stopped: “Lorcaserin removed from market”

paper No significant treatment effect was observed at 12 weeks with lorcaserin compared with placebo PMID 36160639 ↗

paper No significant treatment effect was observed between lorcaserin at 24 weeks compared with placebo PMID 36160639 ↗

Publications

• Hurt RT, Croghan IT, Schroeder DR, Choi DS, Fischer K, Fokken S, Ebbert JO. Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention: A Randomized Clinical Trial. Mayo Clin Proc Innov Qual Outcomes. 2022 Sep 21;6(5):465-474. doi: 10.1016/j.mayocpiqo.2022.01.004. eCollection 2022 Oct.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lorcaserin	Small molecule	—	—
Background	Varenicline	Small molecule	—	—

Indications