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Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Uma Rao, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00129272
First received: August 4, 2005
Last updated: April 17, 2017
Last verified: April 2017
August 4, 2005
April 17, 2017
May 2004
January 2011   (Final data collection date for primary outcome measure)
Smoking Behavior [ Time Frame: Nine weeks ]
Number of cigarettes smoked daily in the previous week
Smoking Behavior
Complete list of historical versions of study NCT00129272 on ClinicalTrials.gov Archive Site
Withdrawal Symptoms [ Time Frame: Nine weeks ]
Hughes-Hatsukami Withdrawal Scale
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.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Tobacco Use Cessation
  • Tobacco Use Disorder
  • Drug: Bupropion-SR
    150mg tablets taken orally twice daily for 9 weeks.
    Other Name: Wellbutrin-SR
  • Other: Placebo
    Matching placebo (to Buproion-SR) twice daily for 9 weeks.
    Other Name: Placebo match for Bupropion (Wellbutrin) SR
  • Active Comparator: Bupropion (Wellbutrin-SR)
    Using a double-blind, randomized, placebo-controlled design, smokers received active treatment with Bupropion-SR (150 mg. twice daily) in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
    Intervention: Drug: Bupropion-SR
  • Placebo Comparator: Matching Placebo
    Using a double-blind, randomized, placebo-controlled design, smokers received treatment with a matching placebo (to Bupropion-SR 150 mg) twice daily in conjunction with cognitive-behavior therapy (weekly sessions) for smoking cessation over a 9-week period.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
172
January 2011
January 2011   (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
Sexes Eligible for Study: All
12 Years to 25 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00129272
NIDA-15131-1
Yes
Not Provided
Plan to Share IPD: No
Uma Rao, National Institute on Drug Abuse (NIDA)
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Uma Rao, MD University of Texas Medical Center
National Institute on Drug Abuse (NIDA)
April 2017

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