Employment-Based Abstinence Reinforcement for Opioid Use Disorder

Recruiting at 1 trial location

Overseen By Forrest Toegel, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northern Michigan University

Must be taking: Methadone, Buprenorphine

Disqualifiers: Recent hallucinations, Prisoner

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

225 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants will continue with methadone or buprenorphine treatment, so you may need to stay on these medications if you are already taking them.

What data supports the effectiveness of the treatment Employment-based abstinence reinforcement for opioid use disorder?

Research shows that employment-based abstinence reinforcement can help people stop using drugs like opiates and cocaine by providing incentives for staying drug-free, such as earning money through work. This approach has been effective in increasing drug abstinence among individuals who are not in traditional treatment programs. ^{1 2 3 4 5}

Is Employment-Based Abstinence Reinforcement for Opioid Use Disorder safe for humans?

Probuphine, a buprenorphine implant, has been shown to be safe in humans, with no serious safety concerns reported in studies. Injection site reactions were common but not serious, and the implant provides a steady release of medication, reducing the risk of misuse. ^{6 7 8 9 10}

How does employment-based abstinence reinforcement differ from other treatments for opioid use disorder?

Employment-based abstinence reinforcement is unique because it combines work opportunities with incentives for staying drug-free, requiring participants to provide drug-negative urine samples to maintain employment and earn maximum pay. This approach integrates employment as a motivator for abstinence, unlike traditional treatments that primarily focus on medication or counseling. ^{1 2 3 4 5}

Research Team

Forrest Toegel, PhD

Principal Investigator

Northern Michigan University

Eligibility Criteria

This trial is for adults over 18 who are unemployed, have opioid use disorder, and are receiving methadone or buprenorphine treatment at REACH. It's not open to prisoners or those experiencing recent hallucinations.

Inclusion Criteria

I am 18 years old or older.

Enrolled at REACH for buprenorphine or methadone maintenance treatment

Unemployed

Exclusion Criteria

Applicants will be excluded if they report recent hallucinations

Applicants will be excluded if they are currently a prisoner.

Timeline

Induction

Participants attend a 4-week induction period to prepare for the intervention

4 weeks

Initiation

Participants earn high magnitude abstinence-contingent wage supplements during the Initiation period

24 weeks

Maintenance

Initiation and Maintenance participants earn low-magnitude abstinence-contingent wage supplements to maintain drug abstinence and employment

24 weeks

Follow-up

Participants are monitored for drug abstinence and employment outcomes after the intervention

4 weeks

Treatment Details

Interventions

• Employment-based abstinence reinforcement

Trial Overview The study tests a 'Therapeutic Workplace' where participants earn wages while staying drug-free. They're randomly assigned to different groups with varying levels of wage incentives tied to providing clean urine samples.

Participant Groups

Group I: Initiation and Maintenance group Experimental Treatment 1 Intervention

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.

Group II: Initiation Only group Experimental Treatment 1 Intervention

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.

Group III: Usual Care Control group Active Control 1 Intervention

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

Employment-based abstinence reinforcement is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Suboxone for:

• Opioid use disorder

Approved in European Union as Suboxone for:

• Opioid dependence

Approved in Canada as Suboxone for:

• Opioid use disorder

Who Is Running the Clinical Trial?

Northern Michigan University

Lead Sponsor

Trials

5

Recruited

410+

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A study involving 33 out-of-treatment injection drug users showed that an employment-based program can effectively reinforce drug abstinence, with participants earning pay contingent on providing drug-negative urine samples.

The introduction of abstinence contingencies for opiates and cocaine led to a significant increase in the percentage of drug-negative urine samples, demonstrating the effectiveness of this approach in promoting abstinence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Employment-based abstinence reinforcement promotes opiate and cocaine abstinence in out-of-treatment injection drug users. Holtyn, AF., Koffarnus, MN., DeFulio, A., et al.[2021]

In a study of 111 unemployed adults in Baltimore's methadone programs, higher attendance rates during an initial induction period were linked to better outcomes in cocaine abstinence when employment-based reinforcement was applied.

The findings suggest that attendance can reflect the motivational value of employment, indicating that improving attendance may enhance the effectiveness of programs designed to reinforce abstinence from cocaine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attendance rates in a workplace predict subsequent outcome of employment-based reinforcement of cocaine abstinence in methadone patients. Donlin, WD., Knealing, TW., Needham, M., et al.[2021]

A study involving adults who inject drugs and use cocaine during methadone treatment showed that employment-based abstinence reinforcement significantly increased cocaine abstinence, with 29% of participants in the abstinence-and-work group providing cocaine-negative urine samples compared to only 10% in the work-only group.

Participants in the abstinence-and-work group were required to provide cocaine-negative urine samples to maintain their employment and maximum pay, demonstrating that linking work to drug abstinence can be an effective strategy for promoting recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of employment-based reinforcement of cocaine abstinence in injection drug users. Silverman, K., Wong, CJ., Needham, M., et al.[2021]

Reinforcement-based therapy (RBT) significantly improved short-term abstinence rates from opioids and cocaine in opioid-dependent patients, with 42% abstinence at 1 month compared to 15% in usual care, and 38% at 3 months compared to 17%.

Patients in the RBT group also reported more days worked and higher legal income over 12 months, indicating that RBT not only helps with abstinence but also supports economic stability, although its long-term efficacy needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reinforcement-based therapy: 12-month evaluation of an outpatient drug-free treatment for heroin abusers. Jones, HE., Wong, CJ., Tuten, M., et al.[2019]

The study involving 46 HIV-positive participants with opioid and/or cocaine dependence found that an employment-based reinforcement intervention did not significantly improve drug abstinence rates compared to a control group over 26 weeks.

While the intervention did not enhance drug abstinence, the work-only group showed better workplace attendance and productivity, suggesting that employment programs can still be beneficial for engagement, even if they don't directly lead to reduced drug use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Employment-based abstinence reinforcement following inpatient detoxification in HIV-positive opioid and/or cocaine-dependent patients. Dunn, KE., Fingerhood, M., Wong, CJ., et al.[2022]

Long-acting buprenorphine formulations, including CAM 2038 (Buvidal), RBP-6000 (Sublocade™), and Probuphine™, provide effective options for treating opioid use disorders (OUDs) with varying administration schedules, such as weekly, monthly, or every six months.

These depot and implant formulations enhance patient adherence to treatment by reducing the frequency of dosing compared to traditional oral or sublingual medications, potentially improving overall outcomes in managing OUDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the treatment of opioid use disorders-focus on long-acting buprenorphine formulations. Soyka, M., Franke, AG.[2021]

Two case studies of pregnant patients with opioid use disorder (OUD) who switched from sublingual buprenorphine to monthly injections of Sublocade® showed no adverse outcomes for either the mothers or their babies, suggesting potential safety in this treatment during pregnancy.

Both patients maintained positive urine drug screens for buprenorphine throughout their pregnancies without experiencing withdrawal symptoms or birth anomalies, indicating that Sublocade may be a viable option for managing OUD in pregnant women, although further research is necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous Extended-Release Buprenorphine Use in Pregnancy. Towers, CV., Deisher, H.[2022]

Probuphine, an implantable formulation of buprenorphine, was evaluated in 12 heroin-dependent volunteers and showed a continuous and effective delivery of medication over 6 months, maintaining low withdrawal symptoms and cravings.

The study found that 59% of urine tests were opioid-negative during treatment, indicating effective management of opioid dependence, with only mild injection site reactions reported and no serious safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Open-label dose-finding trial of buprenorphine implants (Probuphine) for treatment of heroin dependence. White, J., Bell, J., Saunders, JB., et al.[2013]

Probuphine®, a subdermal implant that releases buprenorphine over 6 months, offers a consistent drug delivery method, potentially improving treatment adherence and reducing cravings and withdrawal symptoms in opioid-dependent patients.

This implantable formulation is considered safe and may serve as a better alternative to daily sublingual buprenorphine, as it minimizes fluctuations in drug levels and decreases the need for frequent clinic visits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probuphine® (buprenorphine implant): a promising candidate in opioid dependence. Barnwal, P., Das, S., Mondal, S., et al.[2020]

In a study of 533 participants over 18 months after stopping extended-release buprenorphine injection (BUP-XR), 47% reported sustained opioid abstinence, with higher rates of abstinence linked to longer treatment durations.

More than 60% of participants showed stable or improved outcomes in health-related quality of life and mental health scores, indicating that BUP-XR has a long-term positive impact on recovery from opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Continued Posttrial Benefits of Buprenorphine Extended Release: RECOVER Study Findings. Boyett, B., Nadipelli, VR., Solem, CT., et al.[2023]

References

1. United States pubmed.ncbi.nlm.nih.gov

Employment-based abstinence reinforcement promotes opiate and cocaine abstinence in out-of-treatment injection drug users. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Attendance rates in a workplace predict subsequent outcome of employment-based reinforcement of cocaine abstinence in methadone patients. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of employment-based reinforcement of cocaine abstinence in injection drug users. [2021]

4. Ireland pubmed.ncbi.nlm.nih.gov

Reinforcement-based therapy: 12-month evaluation of an outpatient drug-free treatment for heroin abusers. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Employment-based abstinence reinforcement following inpatient detoxification in HIV-positive opioid and/or cocaine-dependent patients. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Recent advances in the treatment of opioid use disorders-focus on long-acting buprenorphine formulations. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Subcutaneous Extended-Release Buprenorphine Use in Pregnancy. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Open-label dose-finding trial of buprenorphine implants (Probuphine) for treatment of heroin dependence. [2013]

9. England pubmed.ncbi.nlm.nih.gov

Probuphine® (buprenorphine implant): a promising candidate in opioid dependence. [2020]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Continued Posttrial Benefits of Buprenorphine Extended Release: RECOVER Study Findings. [2023]