Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

Study Overview
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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.

Official Title
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An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia

Conditions
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Nicotine Dependence, Schizophrenia

Intervention / Treatment
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* Drug: NRT
* Drug: Bupropion SR 150mg bid
* Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Replapse Prevention Therapy<br> | Drug: NRT<br>* Participants received nicotine replacement therapy in the form of nicotine gum/lozenge and nicotine patch<br>Drug: Bupropion SR 150mg bid<br>* Subjects were given bupropion SR 150 mg bid throughout the course of the study.<br>Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy<br>* Subjects received relapse-prevention oriented cognitive behavioral therapy that was held weekly for 4 weeks, biweekly for 8 weeks, then monthly for 36 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-Day Point Prevalence Abstinence at Month 15 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-Week Continuous Abstinence at Month 15 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine Dependence, Smoking Cessation, Relapse Prevention, Cognitive Behavioral Therapy, Schizophrenia