Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

National Institutes of Health (NIH)

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Tobacco Dependence

Treatments: Drug: Bupropion

Study type: Interventional

Funder types: NIH

Identifiers

NCT00248118

999903382

03-DA-N382

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 13 to 17 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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72 participants in 2 patient groups, including a placebo group

Active medication

Active Comparator group

Description:

300mg bupropion HCL

Treatment:

Drug: Bupropion

Placebo

Placebo Comparator group

Description:

Placebo pill

Treatment:

Drug: Bupropion