Opioid Agonist Therapy for Opioid Use Disorder

(PRIDE III Trial)

Recruiting at 5 trial locations

Overseen By Jin Hee Kim, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Must be taking: Opioid agonists

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

Compensation: Varies

Number of Visits: 12

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve access to Opioid Agonist Therapy (OAT) for treating opioid addiction within prisons and probation systems in Tajikistan, Kyrgyzstan, Moldova, and Georgia. The researchers aim to address barriers to expanding OAT and connect individuals who use drugs to community treatment after release. The focus is on those who inject drugs and are either in prison or on probation. Individuals currently on probation with a history of injecting opioids may find this trial relevant. As an unphased trial, the study seeks to enhance treatment access and support for individuals in challenging environments.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that Opioid Agonist Therapy is safe for individuals with Opioid Use Disorder?

Research has shown that Opioid Agonist Therapy (OAT) can be safe for people with opioid use disorder. Studies have found that patients on OAT use fewer opioids and face lower risks of death, HIV, and hepatitis C during treatment. This indicates that OAT is generally well-tolerated.

However, like any treatment, OAT carries some risks. The risk of overdose can be higher, particularly at the start of treatment. Overall, evidence suggests that OAT is a safe and effective option for many individuals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to scale up Opioid Agonist Therapy (OAT) in unique settings like prisons and probation systems in Eastern Europe and Central Asia (EECA). Unlike traditional methods that might not fully integrate healthcare and public safety, this approach links people with Opioid Use Disorder to community treatment and aligns with public health goals. By creating learning collaboratives with prison and probation officers, the trial hopes to improve the accessibility and effectiveness of OAT, potentially reducing HIV transmission rates and supporting better outcomes after release. This innovative strategy could significantly improve how OAT is implemented in challenging environments, ultimately benefiting individuals and communities.

What evidence suggests that Opioid Agonist Therapy is effective for Opioid Use Disorder?

Research has shown that Opioid Agonist Therapy (OAT) effectively treats opioid addiction. Studies have found that treatments like buprenorphine or methadone, forms of OAT, greatly lower the risk of overdose and reduce the need for emergency medical care. One study found that OAT is linked to more than a 50% lower risk of death from any cause. OAT helps decrease opioid use and its harmful effects. However, despite its effectiveness, many who need OAT do not receive it due to various obstacles. This trial will focus on scaling up OAT as HIV prevention in prisons, pre-trial detention centers, and the probation system in EECA, aiming to improve access and link individuals to community treatment after release. ^{6 7 8 9 10}

Who Is on the Research Team?

Frederick L Altice, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

This trial is for individuals in Tajikistan, Kyrgyzstan, Moldova, and Georgia who are involved with the justice system (prisons or probation) and have HIV or an opioid use disorder. It's focused on those who inject drugs.

Inclusion Criteria

I am over 18 and work as a probation OAT provider.

I am over 18, work as a probation or prison officer with over 3 months experience, and work near an OAT site.

I am 18 or older, use opioids, and am currently on probation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Development of NIATx learning collaboratives with prison OAT providers and collection of OAT scale-up data

4 years

Data collection every 6 months

Scale-Up

Development of NIATx learning collaboratives with probation and prison officers and collection of OAT scale-up data

4 years

Data collection every 6 months

Follow-up

Participants are monitored for adherence to NIATx protocol and effectiveness of OAT scale-up

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Opioid Agonist Therapy

Trial Overview The study is testing how to overcome barriers to implementing Opioid Agonist Therapy (OAT) within prisons and probation systems. It involves creating a learning collaborative based on the NIATx model and analyzing the results using growth analyses.

How Is the Trial Designed?

Group I: Aim 2- Scale-Up Experimental Treatment 1 Intervention

Scale-up OAT as HIV prevention in the newly formed probation system in EECA for individuals with OUD and link them to OAT treatment as part of routine care to align public safety and public health using development of NIATx learning collaboratives with probation and prison officers in Kyrgyzstan, Tajikistan, Moldova, and Georgia. OAT scale-up data will be collected from each member country's national OAT database, and administer a survey to probation officers.

Group II: Aim 1- Implementation Experimental Treatment 1 Intervention

Scale-up Opioid Agonist Therapy (OAT) as HIV prevention in prisons and pre-trial detention centers in EECA for individuals with Opioid Use Disorder (OUD) and link them to community treatment after release using development of NIATx learning collaboratives with prison OAT providers (addiction care specialists or primary care doctors). OAT scale-up data will be collected from each country's national OAT database, as well as administration of survey to prison narcologists.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40919724/

Opioid agonist therapy for opioid use disorder in primary ... Data collection and analysis: Primary outcomes included treatment retention, abstinence from non-prescribed opioids, major adverse events ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2760032

Comparative Effectiveness of Different Treatment Pathways ... Treatment with buprenorphine or methadone was associated with reductions in overdose and serious opioid-related acute care use compared with other treatments.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2772724622000099

Opioid agonist treatment initiation and linkage for ... While the effectiveness is well-established, only a small proportion of individuals with OUD receive OAT due to numerous barriers, spanning financial, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8173472/

Association of Opioid Agonist Treatment With All-Cause ... Our findings suggest a potential public health benefit of OAT, which was associated with a greater than 50% lower risk of all-cause mortality, ...

5. bmjopen.bmj.com bmjopen.bmj.com/content/15/8/e098439

Comparative effectiveness of maintenance doses of opioid ... Introduction. The goal of opioid agonist treatment (OAT) in the treatment of opioid use disorder (OUD) is to reduce opioid use and related harms.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36829242/

Safety and preliminary outcomes of short-acting opioid agonist ... Conclusions: Pilot implementation of sOAT was safe. Compared to prior admissions in the same cohort, the PDD rate was lower, LOS for PDDs was ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1555415523004166

A Cross-sectional Study of Opioid Agonist Therapy Barriers ... Patients with OUD provided with a secure and dependable supply of opioids through OAT encounter positive outcomes, including reduced rates of ...

8. academic.oup.com academic.oup.com/ije/article/54/2/dyaf037/8106779

The Opioid Agonist Treatment and Safety II (OATS II) Study ... Whilst on treatment, evidence of reductions in the risk of death, opioid use, HIV, and hepatitis C infection has been documented [4–6]. The use ...

9. harmreductionjournal.biomedcentral.com harmreductionjournal.biomedcentral.com/articles/10.1186/s12954-025-01157-4

Opioid consumption frequency and its associations with ... This study explores whether reducing opioid use frequency (OUF) during opioid agonist treatment correlates with reduced potential life problems in individuals ...

10. bmjopen.bmj.com bmjopen.bmj.com/content/8/8/e025204

Using routinely collected data to understand and predict ... As with any pharmacological treatment, there are risks associated with OAT. Periods of elevated risk of fatal overdose are observed during treatment induction ( ...