NCT00129272

Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

Stress Response and Smoking Cessation in Depressed Youth

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 172 (actual)
• Sponsor: National Institute on Drug Abuse (NIDA) · NIH
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Not accepted

Summary

Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.

Detailed description

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.

Conditions

• Tobacco Use Cessation
• Tobacco Use Disorder

Interventions

Type	Name	Description
DRUG	Bupropion-SR	150mg tablets taken orally twice daily for 9 weeks.
OTHER	Placebo	Matching placebo (to Buproion-SR) twice daily for 9 weeks.

Timeline

• Start date: 2004-05-01
• Primary completion: 2011-01-01
• Completion: 2011-01-01
• First posted: 2005-08-11
• Last updated: 2017-05-22
• Results posted: 2017-04-18

Locations

1 site across 1 country: United States