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Comparison of Two Counseling Induction Strategies

2015年9月16日 更新者:Michael Kidorf、Johns Hopkins University

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

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Maryland
      • Baltimore、Maryland、美国、21224
        • Addiction Treatment Services -- Hopkins Bayview

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • New admissions to methadone maintenance

Exclusion Criteria:

  • Pregnant
  • Acute medical or psychiatric condition

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

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:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:3-month counseling induction: routine care
Participants assigned to this condition will receive routine stepped-care treatment at ATS. Participants will begin in Step 2 (one counseling session per week), and be advanced to higher intensity care based on missed counseling sessions and drug-positive urine samples. Participants advanced to Step 3 will be scheduled to attend 2 group counseling sessions per week (in addition to individual counseling), and those advanced to Step 4 will be scheduled to attend 8 group counseling sessions per week (in addition to individual counseling). Time of methadone dosing will be based on step of care.
Stepped-based care is routine treatment at ATS. Participants begin a low intensity care, and are advanced to more intensive levels of care (i.e., more intensive schedules of counseling) based on urine samples and counseling adherence.
实验性的:3-month counseling induction: low threshold
Participants assigned to this treatment arm will receive low threshold counseling. These participants will be scheduled to attend one counseling session per month with their individual counselor for the first 3-months. Participants can attend more counseling sessions if they desire, and they can meet with program supervisors to address crisis situations. They can receive methadone dosing any time during the clinic hours (7:30 am-1:15 pm and 4:00 pm - 6:00 pm)
Low threshold care refers to a service delivery method that reduces the treatment demands for new admissions to substance abuse treatment. In the present study, participants will be scheduled to attend less counseling sessions, and will have greater access to methadone.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
treatment retention
大体时间:120 days
The number of days patients remained in treatment over the 120 day study.
120 days

次要结果测量

结果测量
措施说明
大体时间
Drug use
大体时间:weekly observation for 120 days
Urinalysis testing is administered weekly, using a random testing schedule. Samples are tested for the presence of opioids, cocaine, and benzodiazepines
weekly observation for 120 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Michael S Kidorf, Ph.D.、Johns Hopkins University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年9月1日

初级完成 (实际的)

2009年9月1日

研究完成 (实际的)

2009年9月1日

研究注册日期

首次提交

2010年6月10日

首先提交符合 QC 标准的

2010年6月10日

首次发布 (估计)

2010年6月11日

研究记录更新

最后更新发布 (估计)

2015年9月17日

上次提交的符合 QC 标准的更新

2015年9月16日

最后验证

2015年9月1日

更多信息

与本研究相关的术语

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.

stepped-based care的临床试验

3
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