NCT05534815 Long-Term Treatment of Opioid Use Disorder
| NCT ID | NCT05534815 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northern Michigan University |
| Condition | Drug Addiction |
| Study Type | INTERVENTIONAL |
| Enrollment | 225 participants |
| Start Date | 2023-03-01 |
| Primary Completion | 2027-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 225 participants in total. It began in 2023-03-01 with a primary completion date of 2027-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * ≥18 years old * are enrolled at REACH for buprenorphine or methadone maintenance treatment * unemployed Exclusion Criteria: * Applicants will be excluded if they report recent hallucinations and if they are currently a prisoner.
Contact & Investigator
Forrest Toegel, PhD
PRINCIPAL INVESTIGATOR
Northern Michigan University
Frequently Asked Questions
Who can join the NCT05534815 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Drug Addiction. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05534815 currently recruiting?
Yes, NCT05534815 is actively recruiting participants. Contact the research team at ftoegel@nmu.edu for enrollment information.
Where is the NCT05534815 trial being conducted?
This trial is being conducted at Marquette, United States.
Who is sponsoring the NCT05534815 clinical trial?
NCT05534815 is sponsored by Northern Michigan University. The principal investigator is Forrest Toegel, PhD at Northern Michigan University. The trial plans to enroll 225 participants.
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