Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

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

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00248118

Enrollment

Registered

2005-11-03

Start date

2005-01-31

Completion date

2008-05-31

Last updated

2016-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Dependence

Keywords

Randomized, Double-blind, Placebo-controlled

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.

Interventions

DRUGBupropion

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

13 Years to 17 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure	7 weeks

Secondary

Measure	Time frame
Reduction of smoking-related urges and cravings.	7 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026