Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

April 17, 2017 updated by: Uma Rao, National Institute on Drug Abuse (NIDA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

172

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75390 9101
        • University of Texas Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Placebo match for Bupropion (Wellbutrin) SR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoking Behavior
Time Frame: Nine weeks
Number of cigarettes smoked daily in the previous week
Nine weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Withdrawal Symptoms
Time Frame: Nine weeks
Hughes-Hatsukami Withdrawal Scale
Nine weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: Uma Rao, MD, University of Texas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

August 4, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (Estimate)

August 11, 2005

Study Record Updates

Last Update Posted (Actual)

May 22, 2017

Last Update Submitted That Met QC Criteria

April 17, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIDA-15131-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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