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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Nicotine and Smoking Cessation in Schizophrenia

Conditions
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Tobacco-Use Disorder, Schizophrenia, Psychotic Disorders

Intervention / Treatment
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* Drug: bupropion SR
* Behavioral: Cognitive Behavioral Group Therapy
* Drug: nicotine replacement therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Experiment group received 300 mgs of bupropion, in addition to weekly CBT and nicotine replacement therapy | Drug: bupropion SR<br>* Participants were randomly assigned to receive bupropion SR 150 mg or placebo, once daily for 7 days, then twice daily for 11 weeks.<br>* Other names: Zyban, Wellbutrin;Behavioral: Cognitive Behavioral Group Therapy<br>* 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.<br>* Other names: CBT;Drug: nicotine replacement therapy<br>* 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.<br>* Other names: nicotine patch; nicotine gum;|
| Placebo Comparator: II<br>Placebo group received placebo, in addition to weekly CBT and nicotine replacement therapy | Behavioral: Cognitive Behavioral Group Therapy<br>* 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.<br>* Other names: CBT;Drug: nicotine replacement therapy<br>* 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.<br>* Other names: nicotine patch; nicotine gum;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupropion, Zyban, Wellbutrin, Smoking cessation, Schizophrenia, Schizoaffective disorder, Cognitive Behavioral Therapy