Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by National Institute on Drug Abuse (NIDA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00129272
First received: August 4, 2005
Last updated: September 2, 2009
Last verified: September 2009

August 4, 2005
September 2, 2009
May 2004
July 2010   (final data collection date for primary outcome measure)
Smoking Behavior [ Time Frame: nine weeks; six month post treamtent ] [ Designated as safety issue: No ]
Smoking Behavior
Complete list of historical versions of study NCT00129272 on ClinicalTrials.gov Archive Site
Withdrawal symptoms [ Time Frame: nine weeks; six month post treatment ] [ Designated as safety issue: Yes ]
Withdrawal symptoms
Not Provided
Not Provided
 
Effectiveness of Bupropion for Treating Nicotine Dependence in Young People
Stress Response and Smoking Cessation in Depressed Youth

Little is known about the best ways to help young people stop smoking. Bupropion (a medication marketed as Wellbutrin or Zyban) has proved helpful in treating adult smokers. The purpose of this study is to determine if bupropion is also effective in treating smokers between the ages of 12 and 25 years old. This study also compares the effectiveness of bupropion used as a supplement to behavioral treatment versus behavioral treatment used alone. In addition, the study evaluates whether hormonal response to stress measured prior to the start of treatment predicts whether individuals respond well to treatment with medication.

Cigarette smoking and other forms of tobacco exposure are one of the leading preventable causes of morbidity and mortality in the United States. Most smokers begin smoking during adolescence, and though they seem motivated to quit smoking, they frequently fail. Although behavioral treatments are available, they have not been very successful in past studies.

Depressed adults may have more difficulty quitting smoking than non depressed adults; this finding may also apply to depressed youth. The purpose of this study is to determine the effectiveness of bupropion in combination with standard behavioral treatment in helping young smokers quit, as compared to behavioral treatment alone. Finally, the study examines whether hormonal response to stress measured prior to treatment initiation predicts whether individuals respond well to treatment with bupropion.

Participants in this double-blind study will be randomly assigned to receive either bupropion or placebo. Both groups will receive behavioral treatment. The trial will last for 9 weeks, with weekly study visits. Study visits will last 30 minutes to 1 hour and will include medication monitoring, self-reported and biological measures of smoking, and behavioral treatment. Participants will have follow-up visits six months after completion of treatment and at yearly intervals for up to 4 years.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Tobacco Use Cessation
  • Tobacco Use Disorder
  • Drug: Bupropion
    150mg tablets taken orally twice daily.
  • Drug: Placebo
    Participants will receive placebo in this treatment group.
  • Behavioral: CBT Treatment
    Participants will undergo nine weeks of behavioral modification therapy only.
  • Active Comparator: 1
    Participants who will be placed in the active medication treatment group
    Intervention: Drug: Bupropion
  • Placebo Comparator: 2
    Participants who will be placed in the placebo treatment group
    Intervention: Drug: Placebo
  • Experimental: 3
    Participants who will receive cognitive behavioral treatment only
    Intervention: Behavioral: CBT Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2010
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Has smoked at least 10 cigarettes each day for 3 or more months
  • Weighs at least 90 lbs
  • Motivated to quit smoking and has had at least one previous failed attempt
  • Speaks, reads, and writes English
  • Either diagnosed as depressed OR no history of a psychiatric disorder

Exclusion Criteria:

  • History of bipolar disorder, eating disorder, schizophrenia, schizoaffective disorder, autism, or non-nicotine substance use disorder in the 6 months prior to study entry
  • Currently suicidal or with a history of a suicide attempt in the 6 months prior to study entry
  • Psychotic symptoms
  • Use of psychotropic medication(s)
  • Serious medical condition
  • Prior use of bupropion for smoking cessation
  • Currently using other smoking cessation treatments
Both
12 Years to 25 Years
No
Contact: Kathryn Mettman 214-648-5250 kathryn.mettman@utsouthwestern.edu
United States
 
NCT00129272
NIDA-15131-1, R01-15131-1, DPMC
Yes
Dr. Uma Rao, M.D., University of Texas Southwestern Medical Center
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Uma Rao, MD University of Texas Medical Center
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