Drug AddictionNCT05534815
Long-Term Treatment of Opioid Use Disorder
A study testing Employment-based abstinence reinforcement in people with Drug Addiction and Employment, run by Northern Michigan University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Addiction, Employment
- What is being tested?
- Employment-based abstinence reinforcement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2023to 29 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years old
- are enrolled at REACH for buprenorphine or methadone maintenance treatment
- unemployed
Who cannot join
- Applicants will be excluded if they report recent hallucinations and if they are currently a prisoner.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northern Center for Learning and Health, Northern Michigan University, 1401 Presque Isle Ave.
Marquette, Michigan, 49855
Forrest Toegel, PhD, 906-227-2919, ftoegel@nmu.edu
About this study
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.
- The investigators must develop a real-world version of the Therapeutic Workplace that community treatment programs can implement.
- 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.
- Conditions
- Drug Addiction, Employment
- Being tested
- Employment-based abstinence reinforcement
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Employment-based abstinence reinforcementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Employment-based abstinence reinforcement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Mar 2023
- Primary completion28 Feb 2027 (estimated)
- Study completion29 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AddictionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Michigan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Forrest Toegel, PhD, Principal investigator, Northern Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534815
- Sponsor's protocol ID
- IRB00325677
- Other IDs
- R01DA053218-01A1
- Status last verified
- Apr 2025
- First submitted
- 6 Sep 2022
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Treatment of Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05534815
- Acronym / sponsor ID
- IRB00325677
- Conditions
- Drug Addiction, Employment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Northern Michigan UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 29 Feb 2028 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- The investigators must develop a real-world version of the Therapeutic Workplace that community treatment programs can implement.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Employment-based abstinence reinforcementParticipants 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. |
| Initiation and Maintenance group | Experimental | Behavioral: Employment-based abstinence reinforcementThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ≥18 years old
- are enrolled at REACH for buprenorphine or methadone maintenance treatment
- unemployed
Key exclusion criteria (1 listed)
- Applicants will be excluded if they report recent hallucinations and if they are currently a prisoner.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Employment-based abstinence reinforcementParticipants 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. | Behavioural | Initiation Only group, Initiation and Maintenance group |
Primary outcome
Rate of Drug abstinence as assessed by a yes or no
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Forrest Toegel, PhD principal investigator
Northern Michigan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Employment-based abstinence reinforcement in people with Drug Addiction and Employment, run by Northern Michigan University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Forrest Toegel, PhD (906-227-2919, ftoegel@nmu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Drug abstinence as assessed by a yes or no (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.