Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates
SUCCESS
Use of Sibutramine in Smoking Cessation
2 other identifiers
interventional
436
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Sep 2002
Longer than P75 for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2002
CompletedFirst Posted
Study publicly available on registry
May 21, 2002
CompletedStudy Start
First participant enrolled
September 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2008
CompletedMay 21, 2014
May 1, 2014
5.9 years
May 20, 2002
May 20, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Post-cessation weight change
Measured at 1 year follow-up
Smoking cessation
Measured at 1 year follow-up
Study Arms (2)
1
ACTIVE COMPARATORSibutramine plus a behavioral smoking cessation program
2
ACTIVE COMPARATORPlacebo sibutramine plus a behavioral smoking cessation program
Interventions
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.
Both groups of participants will take part in a behavioral smoking cessation program.
Eligibility Criteria
You may qualify if:
- In good general health
- Body mass index greater than or equal to 25
- Currently smoke cigarettes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Tennessee Health Science Center
Memphis, Tennessee, 38163, United States
Related Publications (1)
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.
RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen C. Johnson, MD, MPH
University of Tennessee
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2002
First Posted
May 21, 2002
Study Start
September 1, 2002
Primary Completion
August 1, 2008
Study Completion
August 1, 2008
Last Updated
May 21, 2014
Record last verified: 2014-05