NCT05534815

Long-Term Treatment of Opioid Use Disorder

Recruiting now NA Last updated 2 May 2025

What this trial tests

NA trial testing Employment-based abstinence reinforcement in Drug Addiction in 225 participants. Currently enrolling.

Timeline

1 March 2023

Primary endpoint
28 February 2027

29 February 2028

Quick facts

Lead sponsor	Northern Michigan University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	225
Start date	1 March 2023
Primary completion	28 February 2027
Estimated completion	29 February 2028
Sites	1 location across United States

Drugs / interventions tested

• Employment-based abstinence reinforcement

Conditions studied

• Drug Addiction — all drugs for Drug Addiction →
• Employment — all drugs for Employment →

Sponsor

Northern Michigan University

Who can join

18 and older, any sex, with Drug Addiction or Employment. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.