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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Tennessee
ClinicalTrials.gov Identifier:
NCT00037752
First received: May 20, 2002
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

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 Intervention
Cardiovascular Diseases
Heart Diseases
Obesity
Drug: Sibutramine
Behavioral: Behavioral Smoking Cessation Program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Sibutramine in Smoking Cessation

Resource links provided by NLM:


Further study details as provided by University of Tennessee:

Primary Outcome Measures:
  • Post-cessation weight change [ Time Frame: Measured at 1 year follow-up ] [ Designated as safety issue: No ]
  • Smoking cessation [ Time Frame: Measured at 1 year follow-up ] [ Designated as safety issue: No ]

Enrollment: 436
Study Start Date: September 2002
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00037752

Locations
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Tennessee
Investigators
Principal Investigator: Karen C. Johnson, MD, MPH University of Tennessee Health Science Center
  More Information

No publications provided

Responsible Party: University of Tennessee
ClinicalTrials.gov Identifier: NCT00037752     History of Changes
Other Study ID Numbers: 1176, R01HL068049, R01 HL68049
Study First Received: May 20, 2002
Last Updated: May 20, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Sibutramine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Appetite Depressants
Anti-Obesity Agents

ClinicalTrials.gov processed this record on August 27, 2014