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

• ClinicalTrials.gov Identifier: NCT00037752
• Recruitment Status: Completed
• First Posted: May 21, 2002
• Last Update Posted: May 21, 2014
• Sponsor: University of Tennessee
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Information provided by (Responsible Party): University of Tennessee

Tracking Information

• First Submitted Date: May 20, 2002
• First Posted Date: May 21, 2002
• Last Update Posted Date: May 21, 2014
• Study Start Date: September 2002
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 11, 2007)

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

• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates
• Official Title: Use of Sibutramine in Smoking Cessation
• 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• Cardiovascular Diseases
• Heart Diseases
• Obesity

Intervention

• 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.

Study Arms

• Active Comparator: 1
  Sibutramine plus a behavioral smoking cessation program
  Interventions:

  • Drug: Sibutramine
  • Behavioral: Behavioral Smoking Cessation Program
• Active Comparator: 2
  Placebo sibutramine plus a behavioral smoking cessation program
  Intervention: Behavioral: Behavioral Smoking Cessation Program

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 21, 2006): 436
• Original Enrollment: Not Provided
• Actual Study Completion Date: August 2008
• Actual Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00037752
• Other Study ID Numbers: 1176; R01HL068049 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Tennessee
• Study 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

• PRS Account: University of Tennessee
• Verification Date: May 2014