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Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

Primary Purpose

Tobacco Use Cessation, Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Bupropion-SR
Placebo
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Cessation focused on measuring adolescents, cigarettes, smoking, tobacco

Eligibility Criteria

12 Years - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Bupropion (Wellbutrin-SR)

Matching Placebo

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Smoking Behavior
Number of cigarettes smoked daily in the previous week

Secondary Outcome Measures

Withdrawal Symptoms
Hughes-Hatsukami Withdrawal Scale

Full Information

First Posted
August 4, 2005
Last Updated
April 17, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00129272
Brief Title
Effectiveness of Bupropion for Treating Nicotine Dependence in Young People
Official Title
Stress Response and Smoking Cessation in Depressed Youth
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Cessation, Tobacco Use Disorder
Keywords
adolescents, cigarettes, smoking, tobacco

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
172 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupropion (Wellbutrin-SR)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Bupropion-SR
Other Intervention Name(s)
Wellbutrin-SR
Intervention Description
150mg tablets taken orally twice daily for 9 weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Placebo match for Bupropion (Wellbutrin) SR
Intervention Description
Matching placebo (to Buproion-SR) twice daily for 9 weeks.
Primary Outcome Measure Information:
Title
Smoking Behavior
Description
Number of cigarettes smoked daily in the previous week
Time Frame
Nine weeks
Secondary Outcome Measure Information:
Title
Withdrawal Symptoms
Description
Hughes-Hatsukami Withdrawal Scale
Time Frame
Nine weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uma Rao, MD
Organizational Affiliation
University of Texas Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390 9101
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

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