Addressing Post Cessation Weight Gain

Obesity Clinical Trial

Official title: Varenicline and Lorcaserin for Smoking Cessation and Weight Gain Prevention

Status Terminated

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Obesity
• Smoking Cessation
• Weight Gain

• NCT number: NCT02412631
• Study type: Interventional
• Source: Mayo Clinic
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: June 15, 2016
• Completion date: April 17, 2020