Effectiveness of Bupropion for Treating Nicotine Dependence in Young People

NCT ID: NCT00129272

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 172 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-05-31
• Study Completion Date: 2011-01-31

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.

Conditions

Tobacco Use Cessation; Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Bupropion-SR

Intervention Type: DRUG

150mg tablets taken orally twice daily for 9 weeks.

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

Bupropion-SR

150mg tablets taken orally twice daily for 9 weeks.

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Wellbutrin-SR; Placebo match for Bupropion (Wellbutrin) SR

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

Uma Rao

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Uma Rao, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Medical Center

Locations

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Countries

United States

References

Hajizadeh A, Howes S, Theodoulou A, Klemperer E, Hartmann-Boyce J, Livingstone-Banks J, Lindson N. Antidepressants for smoking cessation. Cochrane Database Syst Rev. 2023 May 24;5(5):CD000031. doi: 10.1002/14651858.CD000031.pub6.

Reference Type: DERIVED

PMID: 37230961 (View on PubMed)

Other Identifiers

NIDA-15131-1

Identifier Type: -

Identifier Source: org_study_id