Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates

Not Applicable

Completed

• Conditions: Heart Diseases; Cardiovascular Diseases; Obesity
• Interventions: Drug: Sibutramine; Behavioral: Behavioral Smoking Cessation Program

• Registration Number: NCT00037752
• Lead Sponsor: University of Tennessee

Brief Summary

The purpose of this study is to determine if sibutramine will decrease post-cessation weight gain and cigarette smoking in overweight and obese smokers who quit smoking.

Detailed Description

BACKGROUND:

Cigarette smoking poses a serious but preventable health risk. Behavioral smoking cessation programs have been shown to help individuals quit smoking. However, concerns about post-cessation weight gain have been reported as a significant barrier to quitting for many smokers. Recently, sibutramine, a new serotonin and norepinephrine reuptake inhibitor drug, has received FDA approval to help people lose weight. Since sibutramine affects neurotransmitters that are important in regulating body weight, it is reasonable to hypothesize that it may decrease post-cessation weight gain in overweight and obese smokers who quit smoking. To date, there have been no studies that compare sibutramine to a placebo, as a way to reduce post-cessation weight gain among overweight and obese smokers who take part in a behavioral smoking cessation program. Therefore, whether sibutramine is effective at reducing post-cessation weight gain in these smokers is unknown. Further, given the neuropharmacologic effects of sibutramine, it is reasonable to speculate that this medication could also be effective in helping individuals quit smoking both initially and in the long term. It is possible that the use of sibutramine, as compared to placebo, may result in a decrease in post-cessation weight gain in overweight and obese individuals who quit smoking. The use of sibutramine may also result in an increase in smoking cessation rates.

DESIGN NARRATIVE:

This study tests the hypothesis that the use of sibutramine, as compared to placebo, will result in a decrease in post-cessation weight gain in overweight and obese individuals who quit smoking, and result in an increase in smoking cessation rates. Participants will be randomly assigned to one of the following two groups: 1) sibutramine plus a behavioral smoking cessation program; or 2) placebo sibutramine plus a behavioral smoking cessation program. Assessments will include post-cessation weight change and smoking cessation rates measured during the study and 9 months following the end of the study.

Study Timeline

• Study First Submitted: 2002-05-20
• Study First Submitted QC: 2002-05-20
• Study First Posted: 2002-05-21
• Study Start: 2002-09
• Primary Completion: 2008-08
• Study Completion: 2008-08
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-20
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

• In good general health
• Body mass index greater than or equal to 25
• Currently smoke cigarettes

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Sibutramine	Sibutramine plus a behavioral smoking cessation program
1	Behavioral Smoking Cessation Program	Sibutramine plus a behavioral smoking cessation program
2	Behavioral Smoking Cessation Program	Placebo sibutramine plus a behavioral smoking cessation program

Primary Outcome Measures

Name	Time	Method
Post-cessation weight change	Measured at 1 year follow-up
Smoking cessation	Measured at 1 year follow-up

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States