Opioid Agonist Therapy for Opioid Use Disorder

(PRIDE III Trial)

Recruiting at 4 trial locations

Overseen By Jin Hee Kim, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

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

Compensation: Varies

Number of Visits: 12

300 Participants Needed

Trial Summary

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 data supports the effectiveness of the drug Opioid Agonist Therapy for opioid use disorder?

Research shows that opioid agonist therapy is effective in reducing the risk of death and improving the quality of life for people with opioid use disorder. It is particularly beneficial for hard-to-reach populations and can be more effective when delivered through accessible treatment platforms. ^{1 2 3 4 5}

Is opioid agonist therapy generally safe for humans?

Opioid agonist therapy is considered a safe and effective treatment for opioid dependence, although there are risks such as fatal overdose. Studies show it can reduce mortality in patients with opioid use disorder, but mortality rates remain higher than in the general population. ^{1 2 3 6 7}

How is opioid agonist therapy different from other treatments for opioid use disorder?

Opioid agonist therapy is unique because it uses medications like buprenorphine/naloxone and methadone to reduce cravings and withdrawal symptoms, making it a first-line treatment for opioid use disorder. It is considered effective and safe, especially for hard-to-reach populations, and has a superior safety profile compared to some other treatments. ^{1 2 3 8 9}

What is the purpose of this trial?

The primary objective of this research project is to identify barriers to scale-up of Opioid Agonist Therapy (OAT) in the justice systems (prisons and probation) in Tajikistan, Kyrgyzstan, Moldova, and Georgia, and establish a NIATx learning collaborative to scale-up OAT, and analyze scale-up utilizing latent class growth analyses in people who inject drugs (PWID).

Research Team

Frederick L Altice, MD

Principal Investigator

Yale University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

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

Reduction in mortality risk with opioid agonist therapy: a systematic review and meta-analysis. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effectiveness and Safety of Low-Threshold Opioid-Agonist Treatment in Hard-To-Reach Populations with Opioid Dependence. [2022]

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

Baseline Factors Associated with Mortality in Patients Who Engaged in Buprenorphine Treatment for Opioid Use Disorder: a Cohort Study. [2022]

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

Treating Withdrawal and Pain in Inpatients With Opioid Use Disorder: A Brief Educational Intervention for Internal Medicine Residents. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Prevalence of alcohol consumption among clients of opioid agonist treatment (OAT) centers in Golestan province, Iran. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Using routinely collected data to understand and predict adverse outcomes in opioid agonist treatment: Protocol for the Opioid Agonist Treatment Safety (OATS) Study. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Availability of opioid agonist treatment and critical incidents in Forensic Clinics for Dependency Diseases in Germany. [2022]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Lacking evidence for the association between frequent urine drug screening and health outcomes of persons on opioid agonist therapy. [2020]

9. Ireland pubmed.ncbi.nlm.nih.gov

Willingness to take buprenorphine/naloxone among people who use opioids in Vancouver, Canada. [2020]