Effectiveness of Bupropion for Treating Nicotine Dependence in Young People
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|ClinicalTrials.gov Identifier: NCT00129272|
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : April 18, 2017
Last Update Posted : May 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Cessation Tobacco Use Disorder||Drug: Bupropion-SR Other: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Stress Response and Smoking Cessation in Depressed Youth|
|Study Start Date :||May 2004|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||January 2011|
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
- 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
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): 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|