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Clinical Trials/NCT01576640
NCT01576640
Terminated
Phase 4

An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia

Massachusetts General Hospital1 site in 1 country17 target enrollmentDecember 2005

Overview

Phase
Phase 4
Intervention
NRT
Conditions
Nicotine Dependence
Sponsor
Massachusetts General Hospital
Enrollment
17
Locations
1
Primary Endpoint
7-Day Point Prevalence Abstinence at Month 15
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2005
End Date
October 2007
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

A. Eden Evins

Director, Center for Addiction Medicine

Massachusetts General Hospital

Eligibility Criteria

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.

Arms & Interventions

Replapse Prevention Therapy

Intervention: NRT

Replapse Prevention Therapy

Intervention: Bupropion SR 150mg bid

Replapse Prevention Therapy

Intervention: Relapse Prevention-Oriented Cognitive Behavioral Therapy

Outcomes

Primary Outcomes

7-Day Point Prevalence Abstinence at Month 15

Secondary Outcomes

  • 4-Week Continuous Abstinence at Month 15

Study Sites (1)

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