Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates (SUCCESS)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00037752 |
|
Recruitment Status :
Completed
First Posted : May 21, 2002
Last Update Posted : May 21, 2014
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Cardiovascular Diseases Heart Diseases Obesity | Drug: Sibutramine Behavioral: Behavioral Smoking Cessation Program | Not Applicable |
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 (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 |
| 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. |
- Post-cessation weight change [ Time Frame: Measured at 1 year follow-up ]
- Smoking cessation [ Time Frame: Measured at 1 year follow-up ]
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- In good general health
- Body mass index greater than or equal to 25
- Currently smoke cigarettes
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00037752
| United States, Tennessee | |
| University of Tennessee Health Science Center | |
| Memphis, Tennessee, United States, 38163 | |
| Principal Investigator: | Karen C. Johnson, MD, MPH | University of Tennessee Health Science Center |
Publications of Results:
| 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 Key Record Dates |
| 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 |