Long-Term Treatment of Opioid Use Disorder

NCT05534815 | Recruiting DMC

• 2 other identifiers: IRB00325677R01DA053218-01A1
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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

Conditions

Drug Addiction; Employment

Outcome Measures

Primary Outcomes (2)

• Rate of Drug abstinence as assessed by a yes or no

  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).

  4 weeks

• Rate of Employment as assessed by a yes or no

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

  4 weeks

Study Arms (3)

Usual Care Control group

NO INTERVENTION

Participants in the Usual Care Control group will receive methadone or buprenorphine treatment, counseling, and employment services.

Initiation Only group

EXPERIMENTAL

Participants assigned to the Initiation Only group will be able to earn abstinence-contingent stipends for working with the employment specialist for up to 20 hours per week and performance stipends for engaging in job-seeking behaviors. When employed, those participants will be able to earn abstinence-contingent wage supplements for up to 40 hours worked (verified by pay stubs) in a community job. Participants can earn from both Therapeutic Workplace Work Hours and from wage supplements for working in a community job, however, participants will only be able to earn stipends and wage supplements for a maximum total of 40 hours.

Behavioral: Employment-based abstinence reinforcement

Initiation and Maintenance group

EXPERIMENTAL

The Initiation and Maintenance group procedures will receive the same intervention as the Initiation Only participants for 24 weeks (during the Initiation period). Then, Initiation and Maintenance participants will receive a low-magnitude incentive intervention for 24 weeks (the Maintenance period, weeks 25-48) to maintain drug abstinence and employment. The low-magnitude incentive intervention will be identical to the final weeks of the high magnitude incentive intervention, with two important exceptions. 1. During the low-magnitude intervention, participants will receive money per hour for maintaining drug abstinence and work (stipends for working with the employment specialist and wage supplements for providing pay stubs). 2. During weeks 25-48, if a participant in the Initiation and Maintenance group provides a drug-positive urine sample or misses a required mandatory sample, the participant will not receive any incentive.

Behavioral: Employment-based abstinence reinforcement

Interventions

Employment-based abstinence reinforcement BEHAVIORAL

Participants will earn stipends for working with the employment specialist and wage supplements for working in a community job, but the stipends and wage supplements will depend on providing drug-free urine samples.

Initiation Only group; Initiation and Maintenance group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northern Michigan University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Northern Center for Learning and Health, Northern Michigan University, 1401 Presque Isle Ave.

Marquette, Michigan, 49855, United States

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Forrest Toegel, PhD

  Northern Michigan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Forrest Toegel, PhD

CONTACT

906-227-2919; ftoegel@nmu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)