Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
- Registration Number
- NCT00248118
- Lead Sponsor
- National Institute on Drug Abuse (NIDA)
- Brief Summary
The purpose of this study is to determine: 1) the short-term clinical efficacy and safety of bupropion for helping adolescent tobacco smokers quit, and 2) The role of withdrawal symptoms in the maintenance of smoking in adolescents.
- Detailed Description
This 10-week study consists of an unassisted (pretrial) acute tobacco withdrawal (AW) phase and a 7-week randomized double-blind placebo-controlled trial of bupropion (300 mg/day) for tobacco dependence. Neuropsychological examinations will be conducted at baseline, during acute withdrawal, and during treatment (incl. early withdrawal) with bupropion. We expect smoking cessation in approximately 25% of the active medication group and significant overall smoking reduction. We postulate that bupropion will also reduce the irritability, depressed mood and anxiety symptoms that typically occur during tobacco withdrawal. We expect to observe optimal cognitive performance, (i.e., attention, memory), and affective state during satiety, impairment during pre-treatment abstinence, and intermediate level cognitive performance in the abstinent active-treatment group. Because limited data are available on cognitive tasks in adolescent smokers, a non-smoking group will be included in order to establish the validity and appropriateness of our paradigm with a normative sample.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 72
- More than 100 lbs
- IQ greater than 80
- General good health
- Not pregnant
- Non-Smoker: No cigarettes in last 6 months, less than 5 in lifetime
- Smokers: Smoke more than 6 cigarettes per day for at least 6 months
- Cardiac, Central Nervous System (CNS) or severe psychiatric disorder
- Psychoactive medications (including nicotine replacement)
- Substance use disorder
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Bupropion Placebo pill Active medication Bupropion 300mg bupropion HCL
- Primary Outcome Measures
Name Time Method Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure 7 weeks
- Secondary Outcome Measures
Name Time Method Reduction of smoking-related urges and cravings. 7 weeks
Trial Locations
- Locations (1)
Teen Tobacco Addiction Research Clinic, NIDA Intramural Research Program
🇺🇸Baltimore, Maryland, United States