Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
Information source: National Institute on Drug Abuse (NIDA)
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Tobacco Dependence
Intervention: Bupropion (Drug)
Phase: Phase 2/Phase 3
Status: Recruiting
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: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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; Recruiting
NOVA Research, Phone: 800-667-7653
Phone: 410-550-1615
Maria J. Gasior, M.D., Ph.D., Sub-Investigator
Michelle K. Leff, M.D., Sub-Investigator
Stephen J. Heishman, Ph.D., Sub-Investigator
Marilyn A. Huestis, Ph.D., Sub-Investigator
Additional Information
Last updated: November 1, 2005
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