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Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia

Status
Terminated
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01576640
Enrollment
17
Registered
2012-04-12
Start date
2005-12-31
Completion date
2007-10-31
Last updated
2015-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nicotine Dependence, Schizophrenia

Keywords

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

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.

Interventions

DRUGNRT

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

DRUGBupropion SR 150mg bid

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

OTHERRelapse 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.

Sponsors

Massachusetts General Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
7-Day Point Prevalence Abstinence at Month 15

Secondary

MeasureTime frame
4-Week Continuous Abstinence at Month 15

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026