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

Primary Purpose

Tobacco-Use Disorder, Schizophrenia, Psychotic Disorders

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
bupropion SR
Cognitive Behavioral Group Therapy
nicotine replacement therapy
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco-Use Disorder focused on measuring Bupropion, Zyban, Wellbutrin, Smoking cessation, Schizophrenia, Schizoaffective disorder, Cognitive Behavioral Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Freedom Trail Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

I

II

Arm Description

Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy

Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy

Outcomes

Primary Outcome Measures

seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline

Secondary Outcome Measures

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

Full Information

First Posted
March 23, 2006
Last Updated
January 10, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00307203
Brief Title
Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke
Official Title
Nicotine and Smoking Cessation in Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
August 1998 (undefined)
Primary Completion Date
February 2004 (Actual)
Study Completion Date
February 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco-Use Disorder, Schizophrenia, Psychotic Disorders
Keywords
Bupropion, Zyban, Wellbutrin, Smoking cessation, Schizophrenia, Schizoaffective disorder, Cognitive Behavioral Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
I
Arm Type
Experimental
Arm Description
Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy
Arm Title
II
Arm Type
Placebo Comparator
Arm Description
Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy
Intervention Type
Drug
Intervention Name(s)
bupropion SR
Other Intervention Name(s)
Zyban, Wellbutrin
Intervention Description
Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Group Therapy
Other Intervention Name(s)
CBT
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
nicotine replacement therapy
Other Intervention Name(s)
nicotine patch; nicotine gum
Intervention Description
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.
Primary Outcome Measure Information:
Title
seven-day point prevalence of smoking reduction, defined as 50 % reduction in serum cotinine levels compared to baseline
Time Frame
end of treatment
Secondary Outcome Measure Information:
Title
continuous smoking reduction (50 % reduction in weekly expired air carbon monoxide (CO) measurements compared to baseline and self report)
Time Frame
end of treatment
Title
continuous tobacco abstinence (weekly expired CO measurements less than 9 ppm and self report)
Time Frame
end of treatment
Title
psychotic symptoms
Time Frame
continuous and end of treatment
Title
negative side effects
Time Frame
continuous
Title
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
Title
measures of attention and memory while attempting to quit smoking
Time Frame
end of treatment
Title
health-related quality at the end of the 3-month treatment and 3-month follow-up phases
Time Frame
continuous and end of treatment
Title
weight gain at the end of the 3-month treatment and 3-month follow-up phases
Time Frame
continuous and end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
A Eden Evins, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Freedom Trail Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17632223
Citation
Evins AE, Cather C, Culhane MA, Birnbaum A, Horowitz J, Hsieh E, Freudenreich O, Henderson DC, Schoenfeld DA, Rigotti NA, Goff DC. A 12-week double-blind, placebo-controlled study of bupropion sr added to high-dose dual nicotine replacement therapy for smoking cessation or reduction in schizophrenia. J Clin Psychopharmacol. 2007 Aug;27(4):380-6. doi: 10.1097/01.jcp.0b013e3180ca86fa.
Results Reference
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Safety and Effectiveness of Sustained Release Bupropion in Treating Individuals With Schizophrenia Who Smoke

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