Suboxone and Methadone for HIV Risk Reduction in Subutex Injectors
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Buprenorphine injecting
研究概览
简要总结
This study will obtain pilot data on the acceptability of a 12-week course of daily observed suboxone and methadone, followed by a dose taper or referral to a local treatment program for 80 opioid dependent patients (40 group) who have been injecting subutex or other buprenorphine preparations 10 or more days in the past 30, and on the impact of each medication on HIV risk and on subutex and opioid use during treatment and a followup at week 20. it will be done at the Uranti Methadone Program, affiliated with the Addiction Research Center, Union Alternative of Georgia in Tbilisi.
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
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •current opioid dependence;
- •injecting buprenorphine 10 or more times in the last 30 days;
- •between 25 and 50 years of age;
- •buprenorphine and/or opiate positive urine test;
- •not on methadone maintenance in last 4 weeks;
- •stable address within Tbilisi and not planning to move;
- •home or cellular phone number where can be reached;
- •able to provide name of family member who knows whereabouts;
- •willingness and ability to give informed consent.
排除标准
- •currently dependent on alcohol, benzodiazepines or other CNS depressants;
- •legan charges with impending incarceration;
- •plans to move from Tbilisi within next 6 months;
- •current participation in another treatment study;
- •serious medical problems that would impair or make hazardous ability to participate;
- •active TB;
- •currently psychotic/suicidal;
- •uncontrolled seizure disorder.
研究组 & 干预措施
Methadone maintenance for 12 weeks
Methadone maintenance for 12 weeks as compared to 12 weeks maintenance on Suboxone.
干预措施: methadone (Drug)
buprenorphine-naloxone (Suboxone)
12 weeks of maintenance on buprenorphine-naloxone (Suboxone) at daily doses ranging from 8 to 32 mg with counseling
干预措施: buprenorphine-naloxone (Suboxone) for 12 weeks (Drug)
结局指标
主要结局
Buprenorphine injecting
时间窗: 12 weeks
1) Obtain pilot data on the impact of a 12-week course of daily, observed Suboxone and methadone treatment on HIV injecting risk behavior, particularly that associated with injecting use of Subutex. 2) obtain pilot data on the degree to which the target population accepts treatment with daily observed Suboxone and methadone.
次要结局
- HIV Risk(12 weeks)