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Completed

NCT Number: NCT00129272

Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

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.

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Key information

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390 9101, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bupropion-SR

Drug

150mg tablets taken orally twice daily for 9 weeks.

Other names: Wellbutrin-SR

Placebo

Other

Matching placebo (to Buproion-SR) twice daily for 9 weeks.

Other names: Placebo match for Bupropion (Wellbutrin) SR

Primary outcomes

  1. Smoking Behavior

    Time frame: Nine weeks

    Number of cigarettes smoked daily in the previous week

Secondary outcomes

  1. Withdrawal Symptoms

    Time frame: Nine weeks

    Hughes-Hatsukami Withdrawal Scale

Sponsors and collaborators

Lead sponsor

National Institute on Drug Abuse (NIDA)

Nih

Registry information

Official study title

Stress Response and Smoking Cessation in Depressed Youth

Important dates

Study start
2004
Primary completion
2011
Study completion
2011
First posted
Aug 11, 2005
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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