Tobacco Use Disorder Clinical Trial
Official title:
Stress Response and Smoking Cessation in Depressed Youth
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.
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 and at yearly intervals for up to 4 years.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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