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

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

Tracking Information
First Submitted Date  ICMJE May 20, 2002
First Posted Date  ICMJE May 21, 2002
Last Update Posted Date May 21, 2014
Study Start Date  ICMJE September 2002
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Heart Diseases
  • Obesity
Intervention  ICMJE
  • 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  ICMJE
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2006)
436
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE August 2008
Actual Primary Completion Date August 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • In good general health
  • Body mass index greater than or equal to 25
  • Currently smoke cigarettes
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00037752
Other Study ID Numbers  ICMJE 1176
R01HL068049 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Tennessee
Study Sponsor  ICMJE University of Tennessee
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Karen C. Johnson, MD, MPH University of Tennessee Health Science Center
PRS Account University of Tennessee
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP