Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

May 19, 2015 updated by: A. Eden Evins, Massachusetts General Hospital

An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford Street

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Replapse Prevention Therapy
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
7-Day Point Prevalence Abstinence at Month 15

Secondary Outcome Measures

Outcome Measure
4-Week Continuous Abstinence at Month 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

April 10, 2012

First Submitted That Met QC Criteria

April 11, 2012

First Posted (Estimate)

April 12, 2012

Study Record Updates

Last Update Posted (Estimate)

May 21, 2015

Last Update Submitted That Met QC Criteria

May 19, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P2008-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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