Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Study Completion Date

2007-10-31

Brief Summary

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After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. The purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate 1 week of abstinence, they continued in the relapse prevention phase of the study, where they continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy.

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Detailed Description

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Conditions

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Nicotine Dependence Schizophrenia

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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Replapse Prevention Therapy

Group Type OTHER

NRT

Intervention Type DRUG

Participants received nicotine replacement therapy in the form of nicotine gum/lozenge and nicotine patch

Bupropion SR 150mg bid

Intervention Type DRUG

Subjects were given bupropion SR 150 mg bid throughout the course of the study.

Relapse Prevention-Oriented Cognitive Behavioral Therapy

Intervention Type OTHER

Subjects received relapse-prevention oriented cognitive behavioral therapy that was held weekly for 4 weeks, biweekly for 8 weeks, then monthly for 36 weeks.

Interventions

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NRT

Participants received nicotine replacement therapy in the form of nicotine gum/lozenge and nicotine patch

Intervention Type DRUG

Bupropion SR 150mg bid

Subjects were given bupropion SR 150 mg bid throughout the course of the study.

Intervention Type DRUG

Relapse Prevention-Oriented Cognitive Behavioral Therapy

Subjects received relapse-prevention oriented cognitive behavioral therapy that was held weekly for 4 weeks, biweekly for 8 weeks, then monthly for 36 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with schizophrenia or schizoaffective disorder by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria
* Reported smoking 10 or more cigarettes per day for at least the prior year
* Expressed a desire to quit smoking and a willingness to set a smoking cessation date within 4 weeks of enrollment
* Were psychiatrically stable on a fixed dose of an antipsychotic for the past 30 days or more
* Reported no active substance use disorder other than nicotine or caffeine within 6 months of enrollment

Exclusion Criteria

* Participants with neurologic risk factors for bupropion treatment were excluded from receiving bupropion but were eligible to participate and receive short- and long-acting NRT and CBT only.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No