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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how the Therapeutic Workplace program can help individuals with opioid use disorder remain drug-free and secure employment. Participants receive rewards for maintaining sobriety, which may reduce poverty and improve job prospects. The study tests various reward strategies to determine the most effective approach. Suitable candidates for this trial include those who are unemployed and currently receiving methadone or buprenorphine treatment (such as Suboxone, Sublocade, or Probuphine) at the REACH clinic. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches that could enhance recovery and employment outcomes.

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 prior data suggests that this method is safe for treating opioid use disorder?

Research shows that programs encouraging people with opioid use disorder to stay drug-free through work are generally well-received. Studies have found that these programs can help people stop using drugs and remain clean. For instance, one study showed that this method led to more drug-free urine tests, indicating its effectiveness and safety.

Moreover, work-based programs like the Therapeutic Workplace have been associated with reduced drug use and better commitment to treatment. Participants are likely to continue with the program, suggesting they do not face major negative effects.

Overall, evidence suggests this type of treatment is safe and well-tolerated for most people. However, individual experiences can differ. It is always wise to consult healthcare providers about any concerns before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about employment-based abstinence reinforcement for opioid use disorder because it introduces a unique approach to addiction treatment. Unlike traditional methods that primarily focus on medication like methadone or buprenorphine, this approach combines employment support with financial incentives to encourage abstinence. The Initiation Only group offers stipends for participating in job-seeking activities and maintaining sobriety, while the Initiation and Maintenance group extends support with additional incentives to sustain drug-free living and employment over a longer period. By integrating work opportunities and financial rewards, this method addresses both the social and economic aspects of recovery, potentially leading to more sustainable outcomes for individuals with opioid use disorder.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

This trial will compare different approaches to employment-based abstinence reinforcement for opioid use disorder. Studies have shown that job-based rewards can effectively help people with opioid addiction stay drug-free. Research indicates that the Therapeutic Workplace method encourages drug-free behavior by providing money for clean drug tests. One study showed that this approach not only helps people stop using drugs but also supports them in maintaining steady jobs. Early findings suggest that this method might help reduce poverty by promoting regular work habits. Overall, these results highlight how job-based rewards can effectively manage opioid addiction and improve lives. ^{4 5 6 7 8}

Who Is on the Research Team?

Forrest Toegel, PhD

Principal Investigator

Northern Michigan University

Are You a Good Fit for This Trial?

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4896162/

EMPLOYMENT-BASED ABSTINENCE REINFORCEMENT ... These results demonstrate that the sequential administration of employment-based abstinence reinforcement can increase opiate and cocaine abstinence.

2. withpower.com withpower.com/trial/phase-2-substance-related-disorders-10-2022-c0fbf

Employment-Based Abstinence Reinforcement for Opioid Use ... This N/A medical study run by Northern Michigan University is evaluating whether Employment-based abstinence reinforcement will have tolerable side effects ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7733028/

Employment outcomes of substance use disorder patients ... The trial evaluated the effectiveness of the therapeutic workplace in promoting opiate and cocaine abstinence and employment in unemployed adults in treatment ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT00249457

Employment-based Reinforcement to Motivate Drug ... The purpose of this study is to determine whether long-term exposure to the Therapeutic Workplace intervention could sustain drug abstinence over an extended ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949875923002060

Integrated analysis of phase 3 studies Extending BUP-XR treatment beyond 6 months sustained improvement in opioid abstinence and was well tolerated, supporting clinical benefit up to 18 months.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3107896/

Employment-Based Reinforcement of Adherence to Depot ... Secondary outcome measures included the percentage of urine samples negative for opiates and cocaine. Also analyzed were the correlation between naltrexone ...

7. dovepress.com dovepress.com/employment-and-long-acting-injectable-buprenorphine-for-opioid-use-dis-peer-reviewed-fulltext-article-SAR

Employment and Long-Acting Injectable Buprenorphine for ... Studies have already found that LAIB can reduce opioid withdrawal symptoms and cravings, improve treatment adherence, and increase abstinence ...

8. clinicaltrials.gov clinicaltrials.gov/show/NCT05534815

Long-Term Treatment of Opioid Use Disorder Many studies have shown that employment-based abstinence reinforcement in the Therapeutic Workplace can promote and maintain drug abstinence. Recently, the ...