Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

NCT01576640 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2015-05-21

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2007-10-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01576640 on ClinicalTrials.gov