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Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

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ClinicalTrials.gov Identifier: NCT00129272
Recruitment Status : Completed
First Posted : August 11, 2005
Results First Posted : April 18, 2017
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Uma Rao, National Institute on Drug Abuse (NIDA)

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Tobacco Use Cessation Tobacco Use Disorder Drug: Bupropion-SR Other: Placebo Phase 2

Detailed Description:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Stress Response and Smoking Cessation in Depressed Youth
Study Start Date : May 2004
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Smoking
U.S. FDA Resources

Arm Intervention/treatment
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.
Drug: Bupropion-SR
150mg tablets taken orally twice daily for 9 weeks.
Other Name: Wellbutrin-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.
Other: Placebo
Matching placebo (to Buproion-SR) twice daily for 9 weeks.
Other Name: Placebo match for Bupropion (Wellbutrin) SR



Primary Outcome Measures :
  1. Smoking Behavior [ Time Frame: Nine weeks ]
    Number of cigarettes smoked daily in the previous week


Secondary Outcome Measures :
  1. Withdrawal Symptoms [ Time Frame: Nine weeks ]
    Hughes-Hatsukami Withdrawal Scale



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Ages Eligible for Study:   12 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT00129272


Locations
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390 9101
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Uma Rao, MD University of Texas Medical Center

Responsible Party: Uma Rao, Professor of Psychiatry, National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier: NCT00129272     History of Changes
Other Study ID Numbers: NIDA-15131-1
First Posted: August 11, 2005    Key Record Dates
Results First Posted: April 18, 2017
Last Update Posted: May 22, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Uma Rao, National Institute on Drug Abuse (NIDA):
adolescents, cigarettes, smoking, tobacco

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