Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke

January 10, 2017 updated by: National Institute on Drug Abuse (NIDA)

Nicotine and Smoking Cessation in Schizophrenia

Many individuals with schizophrenia smoke cigarettes. Individuals in the schizophrenic population often find it difficult to quit smoking. The purpose of this trial is to determine the safety and effectiveness of bupropion in treating individuals with schizophrenia who smoke.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Schizophrenia affects 1 % of the population. Among individuals with schizophrenia, between 74 and 92 % smoke cigarettes regularly. Heavy smoking represents a significant and neglected public health problem for people with schizophrenia; smoking cessation treatment is often overlooked as part of the psychiatric care for such individuals.

The most effective treatment for smoking cessation described to date is sustained release (SR) bupropion. Past research suggests that SR bupropion may be especially effective in individuals with depressive symptoms, including individuals with schizophrenia. The purpose of this trial is to evaluate the safety and efficacy of SR bupropion, when combined with cognitive behavioral therapy (CBT), in individuals with schizophrenia.

This trial will last 12 weeks. Participants will be randomly assigned to receive SR bupropion or placebo. All participants will receive weekly CBT. Participants will be followed for 3 months following completion of the 12-week treatment session.

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Freedom Trail Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meets DSM-IV criteria for schizophrenia or schizoaffective disorder
  • Receiving a stable dose of antipsychotic medication for at least 1 month prior to study entry
  • Smokes at least 10 cigarettes per day
  • Wishes to stop smoking
  • Attended last three scheduled clinic visits, prior to study entry

Exclusion Criteria:

  • Significant medical or neurologic illness
  • History of severe head injury with loss of consciousness
  • Treated with monoamine oxidase inhibitors or carbamazepine in the 14 days prior to study entry
  • Taking clozapine at doses greater than 500 mg/d without an anticonvulsant
  • Currently undergoing an acute exacerbation of psychotic symptoms
  • Current or history of bulimia or anorexia
  • Current excessive water intake
  • Recent history of mania
  • Known allergy or hypersensitivity to bupropion
  • Current substance abuse other than tobacco, nicotine replacement treatment, or smokeless tobacco
  • Currently receiving treatment with bupropion
  • Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: I
Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy
Drug: bupropion SR
Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.
Other Names:
  • Zyban, Wellbutrin
Behavioral: Cognitive Behavioral Group Therapy
Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.
Other Names:
  • CBT
Drug: nicotine replacement therapy
Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.
Other Names:
  • nicotine patch; nicotine gum
Placebo Comparator: II
Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy
Behavioral: Cognitive Behavioral Group Therapy
Participants attended a 12-session, 1-hour, weekly smoking cessation group program with 3 to 7 participants led by a psychologist with tobacco treatment specialist training. Subjects set a quit date, and nicotine patches (Habitrol) and nicotine polacrilex gum (Nicorette) were initiated in the fourth week.
Other Names:
  • CBT
Drug: nicotine replacement therapy
Nicotine patch was dosed at 21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks, then discontinued. Nicotine gum (2 mg) was distributed for use as needed for craving up to 18 mg/d.
Other Names:
  • nicotine patch; nicotine gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline
Time Frame: end of treatment
end of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report)
Time Frame: end of treatment
end of treatment
continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report)
Time Frame: end of treatment
end of treatment
psychotic symptoms
Time Frame: continuous and end of treatment
continuous and end of treatment
negative side effects
Time Frame: continuous
continuous
negative and depressive symptoms compared to baseline at the end of the 3-month treatment and 3-month follow-up phases
Time Frame: continuous and end of treatment
continuous and end of treatment
measures of attention and memory while attempting to quit smoking
Time Frame: end of treatment
end of treatment
health-related quality at the end of the 3-month treatment and 3-month follow-up phases
Time Frame: continuous and end of treatment
continuous and end of treatment
weight gain at the end of the 3-month treatment and 3-month follow-up phases
Time Frame: continuous and end of treatment
continuous and end of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institute on Drug Abuse (NIDA)

Investigators

  • Principal Investigator: A Eden Evins, MD, MPH, Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 1998

Primary Completion (Actual)

February 1, 2004

Study Completion (Actual)

February 1, 2004

Study Registration Dates

First Submitted

March 23, 2006

First Submitted That Met QC Criteria

March 23, 2006

First Posted (Estimate)

March 27, 2006

Study Record Updates

Last Update Posted (Estimate)

January 11, 2017

Last Update Submitted That Met QC Criteria

January 10, 2017

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23DA000510 (U.S. NIH Grant/Contract)
  • DPMC (Other Identifier: NIDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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