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临床试验/NCT00136760
NCT00136760已完成2 期

Incentives Plus Bupropion for Smoking in Schizophrenics

Brown University1 个研究点 分布在 1 个国家目标入组 57 人开始时间: 2003年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
57
试验地点
1
主要终点
Urinary Cotinine

研究概览

简要总结

There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. The aims of this study are to investigate the separate and combined effects of bupropion and a voucher incentive program on smoking in people with schizophrenia.

详细描述

There is a high prevalence of smoking among people with schizophrenia, and there are few smoking treatment programs for these smokers. In this study, we are investigating whether the combination of bupropion (also called Zyban and Wellbutrin) and a behavioral treatment program (contingent vouchers) can reduce smoking in people with schizophrenia. This is a 3-week study aimed to investigate the feasibility of this treatment approach. Participants are randomly assigned to bupropion (300 mg/day, in 2 divided doses) or placebo. After one week on medication, participants are randomly assigned to the active behavioral treatment (contingent vouchers) or the control treatment (non-contingent vouchers). Over a 3-week period, participants come to the study site about 2-3 times per week, and provide information about their recent smoking and nicotine withdrawal symptoms. They also give saliva and urine samples that are analyzed for levels of cotinine, a nicotine metabolite. Participants in the active behavioral treatment group receive gift cards to local grocery stores when their cotinine levels indicate that they have reduced their smoking. Participants in the control behavioral treatment group receive gift cards regardless of cotinine level. Any participant who significantly reduces their smoking at the end of the trial is followed up 2 and 4 weeks after the end of the trial too see if they have sustained these smoking reductions. If we have favorable results from this trial, we will expand it into a smoking treatment program.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of schizophrenia or schizoaffective disorder, smoke 20-50 cpd, clinically stable on antipsychotic and antidepressant medications

排除标准

  • Pregnant/nursing women, seizure disorder, lowered seizure threshold due to other medical conditions, positive urine drug screen positive breath alcohol test, past 2 weeks use of MAO inhibitors, any form of bupropion, cimetidine, phenobarbital, phenytoin, DA agonists, anorectics, stimulants

研究组 & 干预措施

1

Experimental

Contingent reinforcement plus bupropion

干预措施: Bupropion (Drug)

2

Experimental

Contingent reinforcement plus placebo

干预措施: Contingent reinforcement plus placebo (Drug)

3

Experimental

Non-contingent reinforcement plus bupropion

干预措施: non-contingent reinforcement plus bupropion (Drug)

4

Placebo Comparator

Non-contingent reinforcement plus placebo

干预措施: Non-contingent reinforcement plus placebo (Drug)

结局指标

主要结局

Urinary Cotinine

时间窗: 3 weeks

Urinary Cotinine levels at Week 4 (average of last 3 study visits)

次要结局

  • Cigarettes Smoked Per Day(3 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Tidey

Associate Professor (Research), Dept Psychiatry and Human Behavior

Brown University

研究点 (1)

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