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| Sponsor: | National Institute on Drug Abuse (NIDA) |
|---|---|
| Information provided by: | National Institute on Drug Abuse (NIDA) |
| ClinicalTrials.gov Identifier: | NCT00248118 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Dependence |
Drug: Bupropion |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Neurocognitive and Affective Correlates of Tobacco Dependence in Adolescent Smokers and Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking |
| Enrollment: | 72 |
| Study Start Date: | January 2005 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active medication: Active Comparator
300mg bupropion HCL
|
Drug: Bupropion
During treatment phase, participants will take 300 mg bupropion or placebo daily.
|
|
Placebo: Placebo Comparator
Placebo pill
|
Drug: Bupropion
During treatment phase, participants will take 300 mg bupropion or placebo daily.
|
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| Ages Eligible for Study: | 13 Years to 17 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Maryland | |
| Teen Tobacco Addiction Research Clinic, NIDA Intramural Research Program | |
| Baltimore, Maryland, United States, 21224 | |
| Principal Investigator: | Eric T. Moolchan, M.D. | National Institute on Drug Abuse, Intramural Research Program |
More Information
| Responsible Party: | NIDA IRP ( Stephen Heishman, PhD ) |
| Study ID Numbers: | NIDA-IRP-382 |
| Study First Received: | November 1, 2005 |
| Last Updated: | September 9, 2009 |
| ClinicalTrials.gov Identifier: | NCT00248118 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Randomized Double-blind Placebo-controlled |
|
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Tobacco Use Disorder Physiological Effects of Drugs Psychotropic Drugs Disorders of Environmental Origin Pharmacologic Actions |
Mental Disorders Therapeutic Uses Bupropion Substance-Related Disorders Dopamine Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |
