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临床试验/NCT05534815
NCT05534815招募中不适用

Long-Term Treatment of Opioid Use Disorder

Northern Michigan University2 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
225
试验地点
2
主要终点
Rate of Drug abstinence as assessed by a yes or no

研究概览

简要总结

Poverty and opioid addiction are interrelated and chronic problems which have not been addressed adequately. The Therapeutic Workplace could treat the many adults with opioid use disorder who are unemployed and live in poverty. The Therapeutic Workplace pays participants to work. To promote drug abstinence, the Therapeutic Workplace arranges employment-based abstinence reinforcement in which participants are required to provide drug-free urine samples to maintain maximum wages. Many studies have shown that employment-based abstinence reinforcement in the Therapeutic Workplace can promote and maintain drug abstinence. Recently, the investigators showed that abstinence-contingent wage supplements in the Therapeutic Workplace could promote drug abstinence and employment and reduce poverty. However, the investigators have not demonstrated the real-world impacts of the Therapeutic Workplace. The Therapeutic Workplace requires two modifications to produce real world impacts.

  1. The investigators must develop a real-world version of the Therapeutic Workplace that community treatment programs can implement.
  2. The investigators must reduce the costs of maintaining employment-based abstinence reinforcement.

This application seeks to develop and evaluate a low-cost Therapeutic Workplace that community treatment programs can implement and that addresses the persistent nature of opioid addiction and poverty. The investigators propose to conduct a Stage III study in which a community clinic (REACH Health Services) adapts and implements the Therapeutic Workplace intervention. To improve the feasibility of this intervention, the investigators will use low-cost abstinence-contingent wage supplements to maintain abstinence. The investigators propose to conduct a randomized controlled study to evaluate the effectiveness of the low-cost abstinence-contingent wage supplements in a community Therapeutic Workplace to maintain long-term drug abstinence and employment, and to reduce poverty in adults with opioid use disorder. All participants will be invited to attend a 4-week induction period and 48 weeks of support by an employment specialist. At the end of a 4-week induction period, REACH unemployed methadone or buprenorphine patients with opioid use disorder who meet the Induction Period inclusion criteria (N=225) will be randomly assigned to a "Usual Care Control," an "Initiation Only," or an "Initiation and Maintenance" group. All groups will be offered methadone or buprenorphine treatment and an employment specialist for 48 weeks. "Initiation Only" and "Initiation and Maintenance" participants will earn high magnitude abstinence-contingent wage supplements during a 24-week Initiation period (weeks 1-24). "Initiation and Maintenance" participants will also earn low-magnitude abstinence-contingent wage supplements during a 24-week Maintenance period (weeks 25-48). The investigators will base the primary outcome measures on assessments conducted every four weeks of the Maintenance period. If low-cost abstinence-contingent wage supplements in the community Therapeutic Workplace maintain drug abstinence and employment and decrease poverty, community drug abuse treatment clinics could apply this intervention widely as a long-term maintenance treatment for unemployed adults with opioid use disorder.

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
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥18 years old
  • are enrolled at REACH for buprenorphine or methadone maintenance treatment
  • unemployed

排除标准

  • Applicants will be excluded if they report recent hallucinations and if they are currently a prisoner.

结局指标

主要结局

Rate of Drug abstinence as assessed by a yes or no

时间窗: 4 weeks

We will assess rate of urine samples negative for opioids (morphine, oxycodone, and fentanyl) and cocaine at the 4-week assessments during the Maintenance period. Y/N at each assessment).

Rate of Employment as assessed by a yes or no

时间窗: 4 weeks

We will assess rate that participants report employment at the 4-week assessments conducted during the Maintenance period. Y/N at each assessment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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