Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2008-05-31

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.

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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.

Conditions

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Tobacco Dependence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active medication

300mg bupropion HCL

Group Type ACTIVE_COMPARATOR

Bupropion

Intervention Type DRUG

During treatment phase, participants will take 300 mg bupropion or placebo daily.

Placebo

Placebo pill

Group Type PLACEBO_COMPARATOR

Bupropion

Intervention Type DRUG

During treatment phase, participants will take 300 mg bupropion or placebo daily.

Interventions

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Bupropion

During treatment phase, participants will take 300 mg bupropion or placebo daily.

Intervention Type DRUG

Other Intervention Names

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Wellbutrin Zyban

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

Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes