Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

Schizophrenia Clinical Trial

Official title:

An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01576640
• Other study ID #: P2008-04
• Status: Terminated
• Phase: Phase 4
• First received: April 10, 2012
• Last updated: May 19, 2015
• Start date: December 2005
• Est. completion date: October 2007

Study information

• Verified date: May 2015
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Nicotine Dependence
• Schizophrenia
• Tobacco Use Disorder

Intervention

Drug:
• NRT
Participants received nicotine replacement therapy in the form of nicotine gum/lozenge and nicotine patch
• 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.

Locations

Country	Name	City	State
United States	Schizophrenia Program of the Massachusetts General Hospital, Freedom Trail Clinic, 25 Staniford Street	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	7-Day Point Prevalence Abstinence at Month 15			No
Secondary	4-Week Continuous Abstinence at Month 15			No