Effectiveness of Bupropion for Treating Nicotine Dependence in Young People
|Tobacco Use Cessation Tobacco Use Disorder||Drug: Bupropion-SR Other: Placebo||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
|Official Title:||Stress Response and Smoking Cessation in Depressed Youth|
- Smoking Behavior [ Time Frame: Nine weeks ]Number of cigarettes smoked daily in the previous week
- Withdrawal Symptoms [ Time Frame: Nine weeks ]Hughes-Hatsukami Withdrawal Scale
|Study Start Date:||May 2004|
|Study Completion Date:||January 2011|
|Primary Completion Date:||January 2011 (Final data collection date for primary outcome measure)|
Active Comparator: Bupropion (Wellbutrin-SR)
Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
150mg tablets taken orally twice daily for 9 weeks.
Other Name: Wellbutrin-SR
Placebo Comparator: Matching Placebo
Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
Matching placebo (to Buproion-SR) twice daily for 9 weeks.
Other Name: Placebo match for Bupropion (Wellbutrin) SR
Cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the United States. Most smokers begin smoking during adolescence, and though they seem motivated to quit smoking, they frequently fail. Although behavioral treatments are available, they have not been very successful in past studies.
Depressed adults may have more difficulty quitting smoking than non depressed adults; this finding may also apply to depressed youth. The purpose of this study is to determine the effectiveness of bupropion in combination with standard behavioral treatment in helping young smokers quit, as compared to behavioral treatment alone. Finally, the study examines whether hormonal response to stress measured prior to treatment initiation predicts whether individuals respond well to treatment with bupropion.
Participants in this double-blind study will be randomly assigned to receive either bupropion or placebo. Both groups will receive behavioral treatment. The trial will last for 9 weeks, with weekly study visits. Study visits will last 30 minutes to 1 hour and will include medication monitoring, self-reported and biological measures of smoking, and behavioral treatment. Participants will have follow-up visits six months after completion of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00129272
|United States, Texas|
|University of Texas Southwestern Medical Center|
|Dallas, Texas, United States, 75390 9101|
|Principal Investigator:||Uma Rao, MD||University of Texas Medical Center|