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Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

This study has been terminated.
(PI left NIH)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00248118
First Posted: November 3, 2005
Last Update Posted: September 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) )
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):

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

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

Enrollment: 72
Study Start Date: January 2005
Study Completion Date: May 2008
Primary Completion Date: August 2007 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   13 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00248118     History of Changes
Other Study ID Numbers: 999903382
03-DA-N382
First Submitted: November 1, 2005
First Posted: November 3, 2005
Last Update Posted: September 23, 2016
Last Verified: September 2016

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute on Drug Abuse (NIDA) ):
Randomized
Double-blind
Placebo-controlled

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors