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 behavorial 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.

Condition	Intervention	Phase
Tobacco Use Cessation Tobacco Use Disorder	Drug: Bupropion	Phase II

Further Study Details: 

Primary Outcomes: Smoking Behavior
Secondary Outcomes: Withdrawal symptoms
Expected Total Enrollment:  150

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.

Ages Eligible for Study:  12 Years   -   25 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Has smoked at least 10 cigarettes each day for 3 or more months
• Weighs at least 90 lbs
• Motivated to quit smoking and has had at least one previous failed attempt
• Speaks, reads, and writes English
• Either diagnosed as depressed OR no history of a psychiatric disorder

Exclusion Criteria:

• History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, autism, or nonnicotine substance use disorder in the 6 months prior to study entry
• Currently suicidal or with a history of a sucide attempt in the 6 months prior to study entry
• Psychotic symptoms
• Use of psychotropic medication(s)
• Serious medical condition
• Prior use of bupropion for smoking cessation
• Currently using other smoking cessation treatments

Please refer to this study by ClinicalTrials.gov identifier  NCT00129272

Kimberly Warren, B.A.      (214)645-8177    kimberly.warren@utsouthwestern.edu

Texas
      University of Texas Southwestern Medical Center, Dallas,  Texas,  75390 9101,  United States; Recruiting

Study chairs or principal investigators

Uma Rao, M.D.,  Principal Investigator,  UNIVERSITY OF TEXAS SW MED CTR/DALLAS   

Study ID Numbers:  NIDA-15131-1; R01-15131-1
Last Updated:  August 16, 2005
Record first received:  August 4, 2005
ClinicalTrials.gov Identifier:  NCT00129272
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23