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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases; Heart Diseases; Obesity	Drug: Sibutramine; Behavioral: Behavioral Smoking Cessation Program	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	436 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Use of Sibutramine in Smoking Cessation
Study Start Date :	September 2002
Actual Primary Completion Date :	August 2008
Actual Study Completion Date :	August 2008

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Outcome Measures

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Primary Outcome Measures :

1. Post-cessation weight change [ Time Frame: Measured at 1 year follow-up ]
2. Smoking cessation [ Time Frame: Measured at 1 year follow-up ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

University of Tennessee

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:	Karen C. Johnson, MD, MPH	University of Tennessee Health Science Center

More Information

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Publications of Results:

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.

Responsible Party:	University of Tennessee
ClinicalTrials.gov Identifier:	NCT00037752 History of Changes
Other Study ID Numbers:	1176; R01HL068049 ( U.S. NIH Grant/Contract )
First Posted:	May 21, 2002
Last Update Posted:	May 21, 2014
Last Verified:	May 2014

Additional relevant MeSH terms:

Cardiovascular Diseases; Heart Diseases; Sibutramine; Antidepressive Agents	Psychotropic Drugs; Appetite Depressants; Anti-Obesity Agents