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Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

This study has been terminated.
(PI left NIH)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00248118
First received: November 1, 2005
Last updated: April 4, 2011
Last verified: September 2009
History of Changes
  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 2
Phase 3

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

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Reduction of smoking-related urges and cravings. [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]

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 Comparator: Active medication
300mg bupropion HCL
 Drug: Bupropion
During treatment phase, participants will take 300 mg bupropion or placebo daily.
Other Names:
  • Wellbutrin
  • Zyban
Placebo Comparator: Placebo
Placebo pill
 Drug: Bupropion
During treatment phase, participants will take 300 mg bupropion or placebo daily.
Other Names:
  • Wellbutrin
  • Zyban

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
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Eric T. Moolchan, M.D. National Institute on Drug Abuse, Intramural Research Program
  More Information

No publications provided

Responsible Party: Stephen Heishman, PhD, NIDA IRP
ClinicalTrials.gov Identifier: NCT00248118     History of Changes
Other Study ID Numbers: 999903382, 03-DA-N382
Study First Received: November 1, 2005
Last Updated: April 4, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institutes of Health Clinical Center (CC):
Randomized
Double-blind
Placebo-controlled

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
 Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 18, 2013