HIV Risk Reduction and Drug Abuse Treatment in Iran
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Time to resumption of heroin use
研究概览
简要总结
A randomized, double blind clinical trial comparing buprenorphine and naltrexone maintenance treatment when combined with drug abuse and HIV risk reduction counseling (DC-HIV) for heroin and opium addicts in Iran.
详细描述
This randomized double blind clinical trial compares the efficacy of buprenorphine maintenance treatment (BMT) and naltrexone maintenance treatment (NMT) for recently detoxified opioid dependent patients (N=130; 65 heroin dependent, 65 opium dependent-Specific Aim 1). Manual-guided, HIV risk reduction and drug counseling (DC-HIV) is provided to all patients as the platform psychotherapy. Maintenance treatment is provided for 12 weeks to all patients; patients may also continue to receive maintenance treatment for an additional 12 weeks following the initial treatment period. Primary outcome measures, assessed by twice weekly urine toxicology testing and self-report during the first 12 weeks and monthly during the 12-week extension, include resumption of heroin use, 1 and 3 weeks continuous relapse and reductions in HIV risk behaviors. The project will also evaluate the characteristics of treatment-seeking opioid addicts in Iran (including specific risk behaviors and patterns of HIV risk behaviors; prevalence of psychiatric and other medical comorbidity; and patterns of social, family, vocational, and criminal activity and service needs-Specific Aim 2). This data will be used to revise the DC-HIV manual to address the specific circumstances and risk behaviors of opioid addicts in Iran and to provide data regarding any differential response of opium compared to heroin addicts to BMT or NMT. Finally, the project will also provide clinical training for health professionals and training and mentoring in drug abuse treatment and HIV prevention research to clinical researchers who will continue development, implementation, evaluation and dissemination of HIV prevention and drug abuse treatment approaches in Iran after the project ends (Specific Aim 3). The Institute for Cognitive Science Studies will collaboratively fund the project and lead subsequent dissemination and drug abuse and HIV risk reduction efforts in Iran.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Opioid Dependence
排除标准
- •Dependence on alcohol, benzodiazepines or sedatives
- •Suicide or homicide risk
- •Psychotic disorder or major depression
- •Inability to read or understand the protocol or assessment questions
- •Life-threatening or unstable medical problems
- •Greater than 3 times normal liver enzymes (AST, GGT)
研究组 & 干预措施
1
DC-HIV plus buprenorphine maintenance.
干预措施: Buprenorphine/Subutex (Drug)
1
DC-HIV plus buprenorphine maintenance.
干预措施: Drug counseling (Behavioral)
2
DC-HIV plus naltrexone maintenance
干预措施: Naltrexone (Drug)
2
DC-HIV plus naltrexone maintenance
干预措施: Drug counseling (Behavioral)
结局指标
主要结局
Time to resumption of heroin use
时间窗: 26 weeks
Reduction of HIV risks
时间窗: 26 weeks
Time to relapse
时间窗: 26 weeks
Maximum consecutive weeks of opiate abstinence
时间窗: 26 weeks
次要结局
- Adverse events(26 weeks)
- Addiction-related functional status(26 weeks)
