Back to resultsExtended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia
Primary Purpose
Nicotine Dependence, Schizophrenia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
NRT
Bupropion SR 150mg bid
Relapse Prevention-Oriented Cognitive Behavioral Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Nicotine Dependence focused on measuring Nicotine Dependence, Smoking Cessation, Relapse Prevention, Cognitive Behavioral Therapy, Schizophrenia
Eligibility Criteria
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.
Sites / Locations
- Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford Street
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Replapse Prevention Therapy
Arm Description
Outcomes
Primary Outcome Measures
7-Day Point Prevalence Abstinence at Month 15
Secondary Outcome Measures
4-Week Continuous Abstinence at Month 15
Full Information
NCT ID
NCT01576640
First Posted
April 10, 2012
Last Updated
May 19, 2015
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01576640
Brief Title
Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia
Official Title
An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Terminated
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nicotine Dependence, Schizophrenia
Keywords
Nicotine Dependence, Smoking Cessation, Relapse Prevention, Cognitive Behavioral Therapy, Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Replapse Prevention Therapy
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
NRT
Intervention Description
Participants received nicotine replacement therapy in the form of nicotine gum/lozenge and nicotine patch
Intervention Type
Drug
Intervention Name(s)
Bupropion SR 150mg bid
Intervention Description
Subjects were given bupropion SR 150 mg bid throughout the course of the study.
Intervention Type
Other
Intervention Name(s)
Relapse Prevention-Oriented Cognitive Behavioral Therapy
Intervention Description
Subjects received relapse-prevention oriented cognitive behavioral therapy that was held weekly for 4 weeks, biweekly for 8 weeks, then monthly for 36 weeks.
Primary Outcome Measure Information:
Title
7-Day Point Prevalence Abstinence at Month 15
Secondary Outcome Measure Information:
Title
4-Week Continuous Abstinence at Month 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford Street
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia
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