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Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
This study has been terminated.
( PI left NIH )
Study NCT00248118   Information provided by National Institute on Drug Abuse (NIDA)
First Received: November 1, 2005   Last Updated: September 9, 2009   History of Changes

November 1, 2005
September 9, 2009
January 2005
May 2008   (final data collection date for primary outcome measure)
Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00248118 on ClinicalTrials.gov Archive Site
Reduction of smoking-related urges and cravings. [ Time Frame: 7 weeks ] [ Designated as safety issue: Yes ]
Same as current
 
Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
Neurocognitive and Affective Correlates of Tobacco Dependence in Adolescent Smokers and Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking

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.

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.

Phase II, Phase III
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Tobacco Dependence
Drug: Bupropion
  • Active Comparator: 300mg bupropion HCL
  • Placebo Comparator: Placebo pill
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
72
May 2008
May 2008   (final data collection date for primary outcome measure)

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
Both
13 Years to 17 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00248118
Stephen Heishman, PhD, NIDA IRP
NIDA-IRP-382
National Institute on Drug Abuse (NIDA)
 
Principal Investigator: Eric T. Moolchan, M.D. National Institute on Drug Abuse, Intramural Research Program
National Institute on Drug Abuse (NIDA)
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP