Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00037752
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2002-05-20
Brief Title:
Sibutramine to Reduce Weight Gain and Improve Smoking Cessation Rates
Sponsor:
University of Tennessee
Organization:
University of Tennessee
Study Overview
Official Title:
Use of Sibutramine in Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUCCESS
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HL068049 | NIH | None | httpsreporternihgovquickSearchR01HL068049 |