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
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Trial of Relapse Prevention Therapy for Smokers With Schizophrenia

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 7-Day Point Prevalence Abstinence at Month 15 [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 4-Week Continuous Abstinence at Month 15 [ Designated as safety issue: No ]

Enrollment: 17
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01576640

Locations
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
  More Information

No publications provided

Responsible Party: A. Eden Evins, Director, Center for Addiction Medicine, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01576640     History of Changes
Other Study ID Numbers: P2008-04
Study First Received: April 10, 2012
Last Updated: April 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Nicotine Dependence
Smoking Cessation
Relapse Prevention
Cognitive Behavioral Therapy
Schizophrenia

Additional relevant MeSH terms:
Tobacco Use Disorder
Schizophrenia
Substance-Related Disorders
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Nicotine
Bupropion
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014