Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01576640
Recruitment Status : Terminated
First Posted : April 12, 2012
Last Update Posted : May 21, 2015
Information provided by (Responsible Party):
A. Eden Evins, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Nicotine Dependence Schizophrenia Drug: NRT Drug: Bupropion SR 150mg bid Other: Relapse Prevention-Oriented Cognitive Behavioral Therapy Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia
Study Start Date : December 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 7-Day Point Prevalence Abstinence at Month 15

Secondary Outcome Measures :
  1. 4-Week Continuous Abstinence at Month 15

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01576640

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

Responsible Party: A. Eden Evins, Director, Center for Addiction Medicine, Massachusetts General Hospital Identifier: NCT01576640     History of Changes
Other Study ID Numbers: P2008-04
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015

Keywords provided by A. Eden Evins, Massachusetts General Hospital:
Nicotine Dependence
Smoking Cessation
Relapse Prevention
Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Tobacco Use Disorder
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Dopamine Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors