Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01576640
First received: April 10, 2012
Last updated: April 11, 2012
Last verified: April 2012

April 10, 2012
April 11, 2012
Not Provided
Not Provided
7-Day Point Prevalence Abstinence at Month 15 [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01576640 on ClinicalTrials.gov Archive Site
4-Week Continuous Abstinence at Month 15 [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia
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.

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Nicotine Dependence
  • Schizophrenia
  • 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.
Replapse Prevention Therapy
Interventions:
  • Drug: NRT
  • Drug: Bupropion SR 150mg bid
  • Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
Not Provided
Not Provided

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01576640
P2008-04
No
A. Eden Evins, Massachusetts General Hospital
Massachusetts General Hospital
Not Provided
Not Provided
Massachusetts General Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP