Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates (SUCCESS)

Use of Sibutramine in Smoking Cessation

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.

Study Overview

• Status: Completed
• Conditions: Heart Diseases; Cardiovascular Diseases; Obesity
• Intervention / Treatment: Drug: Sibutramine; Behavioral: Behavioral Smoking Cessation Program

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 Type: Interventional
• Enrollment (Actual): 436
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; Sibutramine plus a behavioral smoking cessation program	Drug: Sibutramine; At the baseline study visit, participants in Group 1 will be given a one month supply of 5 mg/d of sibutramine and a 1-month follow-up visit will be scheduled. After a safety evaluation at the 1-month follow-up visit, participants will have their dose of sibutramine titrated to 10 mg/d, a 1 month supply of the medication will be given to participants, and a 2-month follow-up visit will be scheduled. After a safety evaluation at the 2-month follow-up visit, participants will receive a 1 month supply of sibutramine 10 mg/d and a 3-month follow-up visit will be scheduled. At the 3-month follow-up visit, the sibutramine will be discontinued and participants will be scheduled for 4- and 5-month follow-up visits.; Behavioral: Behavioral Smoking Cessation Program; Both groups of participants will take part in a behavioral smoking cessation program.
Active Comparator: 2; Placebo sibutramine plus a behavioral smoking cessation program	Behavioral: Behavioral Smoking Cessation Program; Both groups of participants will take part in a behavioral smoking cessation program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Post-cessation weight change	Measured at 1 year follow-up
Smoking cessation	Measured at 1 year follow-up

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Karen C. Johnson, MD, MPH, University of Tennessee Health Science Center

Publications and helpful links

General Publications

• DeBon M, Johnson KC, Bush A, and Klesges RC. (2008, March). The efficacy of sibutramine to prevent or decrease post cessation weight gain in overweight and obese smokers. Paper presented at the 29th annual meeting of the Society of Behavioral Medicine, San Diego, CA. March 2008.

Study record dates

Study Major Dates

• Study Start: September 1, 2002
• Primary Completion (Actual): August 1, 2008
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: May 20, 2002
• First Submitted That Met QC Criteria: May 20, 2002
• First Posted (Estimate): May 21, 2002

Study Record Updates

• Last Update Posted (Estimate): May 21, 2014
• Last Update Submitted That Met QC Criteria: May 20, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Psychotropic Drugs; Antidepressive Agents; Appetite Depressants; Anti-Obesity Agents; Sibutramine
• Other Study ID Numbers: 1176; R01HL068049 (U.S. NIH Grant/Contract)