Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

NCT01576640 | Terminated Phase 4

• 1 other identifier: P2008-04
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine Dependence; Schizophrenia

Keywords

Nicotine Dependence; Smoking Cessation; Relapse Prevention; Cognitive Behavioral Therapy; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 7-Day Point Prevalence Abstinence at Month 15

Secondary Outcomes (1)

• 4-Week Continuous Abstinence at Month 15

Study Arms (1)

Replapse Prevention Therapy

OTHER

Drug: NRT; Drug: Bupropion SR 150mg bid; Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy

Interventions

NRT DRUG

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

Replapse Prevention Therapy

Bupropion SR 150mg bid DRUG

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

Replapse Prevention Therapy

Relapse Prevention-Oriented Cognitive Behavioral Therapy 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.

Replapse Prevention Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford Street

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Schizophrenia; Smoking Cessation

Interventions

BID protein, human

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Addiction Medicine

Study Record Dates

• First Submitted: April 10, 2012
• First Posted: April 12, 2012
• Study Start: December 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: May 21, 2015

Record last verified: 2015-05

Locations

US (1)