Contingency Management of Psychostimulant Abuse in the Severely Mentally Ill
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Stimulant drug use as measured by urine analysis
研究概览
简要总结
The purpose of this study is to determine the effectiveness of a behavioral treatment, contingency management, in reducing stimulant use in persons with serious mental illness.
详细描述
This study will evaluate the efficacy of a twelve week contingency management (CM) intervention for treating psycho-stimulant substance abuse when delivered in the context of a community mental health center (CMHC) setting for adults suffering from serious mental illness (SMI). The CM paradigm to be used is one which has been shown effective in several recent large clinical trials, using the variable magnitude of reinforcement procedure. The reinforcers will be vouchers or actual items useful for day to day living in this population. Two hundred SMI participants with co-occurring stimulant disorders will be recruited from a large urban CMHC and randomized to receive either the active CM paradigm plus treatment as usual (TAU), or TAU which will include the delivery of reinforcement for study involvement (reinforcement that is not contingent on drug abstinence). The primary outcome is change in psycho-stimulant use (methamphetamine, amphetamine and/or cocaine). Secondary outcomes include: changes in use of other illegal drugs or alcohol; changes in CMHC treatment adherence and follow-through; changes in psychiatric symptoms, quality of life, and community outcomes (homelessness, incarcerations, etc.). Additional outcomes to be measured include changes in drug craving, stage of change, nicotine use, and HIV risk status. The study involves two phases, the 12 week treatment phase, where CM and control treatments are delivered, as well as a 3 month follow up phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrolled patient at Community Psychiatric Clinic (CPC), a large mental health center in urban Seattle, Washington;
- •Between 18 and 65 years of age;
- •Diagnosis of of methamphetamine, amphetamine(illegal), or cocaine dependence or abuse;
- •CPC medical record diagnosis of schizophrenia, schizoaffective disorder, bipolar I or II, or recurrent major depressive disorder
- •Stimulant drug use one month before enrollment;
- •Ability to understand written and spoken English;
- •CPC clinical case manager must affirm the potential participant's ability to provide informed consent and clinical appropriateness (i.e., safety/severity of mental/substance/ physical health) to participate in the study.
排除标准
- •Any medical/psychiatric condition, or severity of that condition, that, in the opinion of Dr. Ries, the PI, would compromise safe study participation
- •Chart defined organic brain disorder or dementia;
- •Current participation in a methadone maintenance program;
- •Any other circumstances that in the PI's opinion precludes safe study participation.
研究组 & 干预措施
2
Non Contingent Control Condition
干预措施: Non Contingent Control Condition (Behavioral)
1
Contingency management
干预措施: Contingency Management (Behavioral)
结局指标
主要结局
Stimulant drug use as measured by urine analysis
时间窗: Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month)
次要结局
- Self report drug use(Measured monthly througout the study)
- Other drug use as measured by urine analysis(Treatment phase: 12 weeks (3 measurements a week), Follow Up Phase: 3 months (1 measuresment a month))
- Symptoms of mental illness(Monthly throughout the study)
- Community outcomes (jail bookings, ER visits, mental health outcomes)(The entire study period and three months prior and after study involvement)
研究者
Richard Ries
Director Division of Addiction
University of Washington