Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

Study Overview
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Brief Summary
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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
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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.

Official Title
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Neurocognitive and Affective Correlates of Tobacco Dependence in Adolescent Smokers and Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Drug: Bupropion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Cardiac, Central Nervous System (CNS) or severe psychiatric disorder Psychoactive medications (including nicotine replacement) Substance use disorder

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active medication<br>300mg bupropion HCL | Drug: Bupropion<br>* During treatment phase, participants will take 300 mg bupropion or placebo daily.<br>* Other names: Zyban;|
| Placebo Comparator: Placebo<br>Placebo pill | Drug: Bupropion<br>* During treatment phase, participants will take 300 mg bupropion or placebo daily.<br>* Other names: Zyban;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of smoking-related urges and cravings. |  | 7 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized, Double-blind, Placebo-controlled