Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1

Study Overview
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Brief Summary
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Schizophrenic individuals are typically nicotine dependent smokers who find it difficult to quit smoking. The purpose of this study is to determine the effectiveness of bupropion SR (commonly known as Zyban) in combination with a nicotine transdermal patch (NTP), in helping schizophrenic individuals quit smoking. In addition, this study will evaluate how the combination of bupropion SR and NTP affects psychiatric symptoms and medication side effects.

Detailed Description
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Past research on the use of the NTP, atypical antipsychotics, and bupropion in schizophrenic individuals to aid in smoking cessation has been encouraging. The purpose of this study is to compare bupropion SR to a placebo to determine its effectiveness when used in combination with an NTP to help schizophrenic individuals quit smoking. Participants in this double-blind, placebo-controlled study will be randomly assigned to receive either the NTP (21 mg/day) and placebo or the NTP and bupropion SR (300 mg/day). Participants will begin taking one pill each day of bupropion SR (150 mg/day) or placebo at the start of the second week of the study. After three days, the dose of bupropion SR or placebo will increase to 2 pills each day. Participants will continue this dosing regimen until the end of Week 10. Throughout the 10-week study, participants will receive weekly group therapy.

Official Title
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Optimizing Treatment for Schizophrenic Smokers

Conditions
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Tobacco Use Cessation, Tobacco Use Disorder, Schizophrenia

Intervention / Treatment
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* Drug: Bupropion
* Drug: nicotine transdermal patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: DSM-IV diagnosis of schizophrenia or schizoaffective disorder and nicotine dependence Fagerstrom Test for Nicotine Dependence (FTND) score greater than 5 Smokes at least 20 cigarettes per day (1 pack per day) Expired breath CO level > 10 ppm and cotinine level > 210 ng/ml at the baseline measurement Currently taking a stable dose of antipsychotic Complete remission from positive symptoms of psychosis as judged by a psychiatric evaluation Exclusion Criteria: Meets criteria for current abuse or dependence for any alcohol or illicit substance within the past month History of hypersensitivity to bupropion or the nicotine transdermal patch (NTP) Current diagnosis of a serious documented medical disorder that would make bupropion treatment risky OR results of psychiatric/medical screening that suggest a reason for concern (e.g., a history of severe heart, liver, or kidney disease or diabetes mellitus) Currently taking monoamine oxidase inhibitors or bupropion (Zyban or Wellbutrin) Currently taking diabetes mellitus medications, St. John's Wort, appetite suppressants, ephedrine-containing medications, theophylline, clonidine, reserpine, methyldopa, or anti-anginal medications (e.g., beta-blockers, calcium channel blockers, nitroglycerin preparations) History of schizoaffective disorder and not stabilized on a mood stabilizer (e.g., lithium, valproate, carbamazepine)

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Nicotine Patch + Bupropion | Drug: Bupropion<br> <br> Drug: nicotine transdermal patch<br> <br> |
| Placebo Comparator: 2<br>Nicotine patch + placebo | Drug: nicotine transdermal patch<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7 day point prevalence of cigarette abstinence |  | End of trial (week 10) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Craving |  | assessed weekly | 
| Medication compliance |  | assessed weekly | 
| Depression |  | assessed at weeks 1, 4, 7, 10 and at six-month followup | 
| Withdrawal symptoms |  | assessed weekly and at six month followup | 
| Schizophrenic symptoms |  | assessed at weeks 1, 4, 7, 10 and at six-month followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nicotine dependence