Treating Nicotine Dependence in Schizophrenic Individuals: Effectiveness of Bupropion - 1
Optimizing Treatment for Schizophrenic Smokers
研究概览
详细说明
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.
研究类型
注册 (实际的)
阶段
- 阶段2
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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)
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：1
Nicotine Patch + Bupropion
|
|
|
安慰剂比较：2
Nicotine patch + placebo
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
7 day point prevalence of cigarette abstinence
大体时间：End of trial (week 10)
|
End of trial (week 10)
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Craving
大体时间：assessed weekly
|
assessed weekly
|
|
Medication compliance
大体时间：assessed weekly
|
assessed weekly
|
|
Depression
大体时间：assessed at weeks 1, 4, 7, 10 and at six-month followup
|
assessed at weeks 1, 4, 7, 10 and at six-month followup
|
|
Withdrawal symptoms
大体时间：assessed weekly and at six month followup
|
assessed weekly and at six month followup
|
|
Schizophrenic symptoms
大体时间：assessed at weeks 1, 4, 7, 10 and at six-month followup
|
assessed at weeks 1, 4, 7, 10 and at six-month followup
|
合作者和调查者
调查人员
- 首席研究员：Tony P George, M.D.、Yale University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.