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Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

Information source: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Tobacco Dependence

Intervention: Bupropion (Drug)

Phase: Phase 2/Phase 3

Status: Terminated

Sponsored by: National Institute on Drug Abuse (NIDA)

Official(s) and/or principal investigator(s):
Eric T. Moolchan, M.D., Principal Investigator, Affiliation: National Institute on Drug Abuse, Intramural Research Program

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure

Secondary outcome: Reduction of smoking-related urges and cravings.

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.

Eligibility

Minimum age: 13 Years. Maximum age: 17 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Teen Tobacco Addiction Research Clinic, NIDA Intramural Research Program, Baltimore, Maryland 21224, United States
Additional Information

Starting date: January 2005
Last updated: April 4, 2011

Page last updated: August 23, 2015

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