Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Terminated

CT.gov ID

NCT01576640

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Nicotine Dependence Schizophrenia	Drug: NRT Drug: Bupropion SR 150mg bid Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia

Study Start Date :

Dec 1, 2005

Actual Primary Completion Date :

Oct 1, 2007

Actual Study Completion Date :

Oct 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Other: Replapse Prevention Therapy	Drug: NRT Participants received nicotine replacement therapy in the form of nicotine gum/lozenge and nicotine patch Drug: Bupropion SR 150mg bid Subjects were given bupropion SR 150 mg bid throughout the course of the study. Other: 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.

Arm

Intervention/Treatment

Other: Replapse Prevention Therapy

Drug: NRT

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

Drug: Bupropion SR 150mg bid

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

Other: 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.

Outcome Measures

Primary Outcome Measures

7-Day Point Prevalence Abstinence at Month 15 []

Secondary Outcome Measures

4-Week Continuous Abstinence at Month 15 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.