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临床试验/NCT01141920
NCT01141920已完成不适用

Comparison of Two Different Counseling Schedules on Treatment Response of New Admissions to Methadone Maintenance

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
2
主要终点
treatment retention

研究概览

简要总结

New admissions (n = 120) to the Addiction Treatment Services (ATS) will be stabilized on methadone and randomly assigned to one of two induction conditions: 1) routine stepped care, or 2) low threshold stepped care. All participants will continue with routine stepped care in month 4. Treatment retention is the primary outcome measure, while drug use (measured via weekly urinalysis testing) is the major secondary outcome.

详细描述

This randomized clinical trial will evaluate two induction strategies for helping out-of-treatment opioid abusers transition to methadone maintenance treatment. All study participants (n = 120) will be new admissions to the Addiction Treatment Services at Hopkins Bayview (ATS), stabilized on 80 mg of methadone, and randomly assigned to one of two study conditions. The experimental induction condition will receive low threshold stepped care (LTSC) for the first 3-month of treatment that reduces the counseling demands of maintenance treatment (i.e., one counseling session / month). This condition will be compared to routine stepped care (RSC) for the first 3-months, which provides escalating intensity of counseling schedules contingent on drug use or poor adherence. RSC is routine treatment at ATS. All participants will receive routine stepped care following the 3-month induction phase, and will have the opportunity to remain in treatment at ATS following study participation. Participation is for 4-months. Retention is the primary outcome. Participants will also submit urine samples weekly on a random schedule each month. We hypothesize that LTSC participants will exhibit better retention than RSC participants, and that both conditions will exhibit reductions in drug use compared to baseline.

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

入选标准

  • New admissions to methadone maintenance

排除标准

  • Acute medical or psychiatric condition

结局指标

主要结局

treatment retention

时间窗: 120 days

The number of days patients remained in treatment over the 120 day study.

次要结局

  • Drug use(weekly observation for 120 days)

研究者

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

Michael Kidorf

Associate Professor

Johns Hopkins University

研究点 (2)

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