Viewing Study NCT00006170



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Last Modification Date: 2024-10-26 @ 9:05 AM
Study NCT ID: NCT00006170
Status: COMPLETED
Last Update Posted: 2016-07-21
First Post: 2000-08-09

Brief Title: Bupropion and Weight Control for Smoking Cessation - 1
Sponsor: University of Pittsburgh
Organization: University of Pittsburgh

Study Overview

Official Title: Bupropion and Weight Control for Smoking Cessation
Status: COMPLETED
Status Verified Date: 2016-06
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: None
Brief Summary: The purpose of this study is to determine whether the addition of bupropion Zyban to cognitive behavioral therapy CBT will enhance longer-term tobacco abstinence in women
Detailed Description: Although rates of smoking have declined the decrease in prevalence has been much less pronounced in women than in men and women are particularly vulnerable to ongoing smoking-related morbidity and mortality One important reason for gender differences in smoking cessation is concern about cessation-related weight gain among women which is associated with poorer cessation outcome We previously documented that cognitive behavior therapy to minimize weight concerns CBT was effective in promoting cessation and controlling weight gain among weight concerned women smokers The current study is a randomized double-blind controlled trial to determine whether the addition of bupropion Zyban to CBT 12 sessions over 14 weeks with 6 booster sessions will enhance longer-term abstinence Bupropion was the clear medication of choice for this trial because it is efficacious in promoting smoking cessation attenuates cessation-related weight gain particularly in women and relieves negative mood which appears more common in weight-concerned women Four hundred fifty weight concerned women smokers will be randomized to either CBT for weight concerns plus standard cessation or standard smoking cessation only and six months of either bupropion Zyban or placebo 2 x 2 design Primary outcome will be rates of smoking abstinence at 1 year and time to relapse across the four treatment conditions In addition we will determine the effects of these treatments on tobacco withdrawal mood and weight Results of this investigation will provide information on the relative efficacy of the CBT intervention and bupropion alone and in combination and the utility of drug and counseling strategies that are specifically tailored for a high-risk population

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
R01DA004174 NIH None httpsreporternihgovquickSearchR01DA004174