Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

Phase 4

Terminated

• Conditions: Nicotine Dependence; Schizophrenia
• Interventions: Drug: NRT; Drug: Bupropion SR 150mg bid; Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy

• Registration Number: NCT01576640
• Lead Sponsor: Massachusetts General Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Study First Submitted: 2012-04-10
• Study First Submitted QC: 2012-04-11
• Study First Posted: 2012-04-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-19
• Last Update Posted: 2015-05-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Replapse Prevention Therapy	Bupropion SR 150mg bid	-
Replapse Prevention Therapy	NRT	-
Replapse Prevention Therapy	Relapse Prevention-Oriented Cognitive Behavioral Therapy	-

Primary Outcome Measures

Name	Time	Method
7-Day Point Prevalence Abstinence at Month 15

Secondary Outcome Measures

Name	Time	Method
4-Week Continuous Abstinence at Month 15

Trial Locations

Locations (1)

Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford Street; 🇺🇸 Boston, Massachusetts, United States