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Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
This study is currently recruiting participants.
Verified by National Institute on Drug Abuse (NIDA), November 2005
First Received: November 1, 2005   No Changes Posted
Sponsored by: 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, 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

Resource links provided by NLM:


Further study details as provided by National Institute on Drug Abuse (NIDA):

Estimated Enrollment: 157
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

Ages Eligible for Study:   13 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00248118

Locations
United States, Maryland
Teen Tobacco Addiction Research Clinic, NIDA Intramural Research Program Recruiting
Baltimore, Maryland, United States, 21224
Contact: NOVA Research     800-667-7653        
Contact     410-550-1615        
Sub-Investigator: 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.            
Sponsors and Collaborators
Investigators
Principal Investigator: Eric T. Moolchan, M.D. National Institute on Drug Abuse, Intramural Research Program
  More Information

No publications provided

Study ID Numbers: NIDA-IRP-382
Study First Received: November 1, 2005
Last Updated: November 1, 2005
ClinicalTrials.gov Identifier: NCT00248118     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Drug Abuse (NIDA):
Randomized
Double-blind
Placebo-controlled

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Tobacco Use Disorder
Psychotropic Drugs
Disorders of Environmental Origin
Smoking
Dopamine
Mental Disorders
Bupropion
Substance-Related Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on July 02, 2009