Combination Pharmacotherapy for Smoking Cessation Among Methadone Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2002-12-31

Brief Summary

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The purpose of this pilot study is to examine the effects of combined pharmacotherapy (Zyban/NRT)/behavioral treatment on smoking cessation among methadone maintenance therapy patients.

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Detailed Description

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This is a one-arm, open label pilot study of MMT patients to determine whether bupropion, nicotine replacement therapy, and behavioral counseling is a feasible and potentially effective intervention for smoking cessation. The smoking behaviors of participants will be be followed for 6 months post quit-date to determine effect-size estimates for a future, large scale trial.

Conditions

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Tobacco Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combined Pharmacotherapy and Counseling

300 mg Bupropion/4mg Nicotine Gum/Motivational Interviewing

Group Type EXPERIMENTAL

Combined intervention

Intervention Type OTHER

300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling

Interventions

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Combined intervention

300 mg bupropion plus 4mg nicotine gum ad lib plus motivational interviewing counseling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients in long-term methadone maintenance treatment
* Patient smokes at least 10 cigarettes per day, are stable on their use of methadone (phase 2 or higher treatment), smoked for at least 1 year, be willing to participate for 6 months, and not have used bupropion or nicotine replacement therapy for 6 months

Exclusion Criteria

* Patients who use prescription drug regimens that might affect methadone or bupropion metabolism
* Patients with cardiovascular disease, asthma, COPD
* Patients who are pregnant or breastfeeding
* Patients with regular use of alcohol, other illicit drugs, or other types of tobacco (chewing or pipe for example)

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No