Peer-led Intervention for Opioid Use Disorder

(THRIVE Trial)

Recruiting at 2 trial locations

Overseen By Research Program Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Dementia, Cognitive impairments, Acute psychiatric, others

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

Compensation: Varies

Number of Visits: 4

390 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What data supports the effectiveness of the THRIVE Intervention treatment for opioid use disorder?

Research shows that peer recovery support services, like those used in the THRIVE Intervention, can help people with opioid use disorder start and stick with their treatment. Peer-led approaches have been successful in encouraging treatment engagement and reducing relapse, especially when peers are trained to deliver behavioral interventions. ^{1 2 3 4 5}

Is the peer-led intervention for opioid use disorder safe for humans?

The research articles do not provide specific safety data for the peer-led intervention, but they discuss its use in various settings to support treatment engagement and reduce overdose risk, suggesting it is generally considered safe in these contexts. ^{1 3 6 7 8}

How is the THRIVE Intervention treatment different from other treatments for opioid use disorder?

The THRIVE Intervention is unique because it uses peer recovery specialists, individuals with personal experience in substance use and recovery, to deliver support and behavioral activation interventions. This peer-led approach is designed to increase engagement in medication for opioid use disorder and improve treatment retention, offering a more relatable and supportive experience compared to traditional clinical settings. ^{1 2 3 9 10}

What is the purpose of this trial?

The purpose of the study is to develop an acceptable, feasible, and effective peer-led bundle of harm reduction services to be delivered in the hospital setting, called the THRIVE intervention. The main question it aims to answer is: Will participants receiving the THRIVE intervention have a reduced risk of self-reported non-fatal overdoses OR skin/soft tissue infections compared to participants receiving enhanced usual care? Researchers will compare the THRIVE model to enhanced usual care to see if the THRIVE model helps participants reduce their number of self-reported non-fatal overdoses OR skin/soft tissue infections. Intervention participants will: * Receive one in-person session from a peer support specialist while in the hospital * Receive weekly text messages from the peer support specialist for a 12-week period * Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6 * Complete a baseline, 3-month, and 6-month assessment with Research Assistants Enhanced usual care participants will: * Receive a handout with harm reduction education and resources in their local area * Receive monthly, multiple-choice assessments via text message at Month 1, 2, 3, 4, 5, and 6 * Complete a baseline, 3-month, and 6-month assessment with Research Assistants

Research Team

Jacqueline D Wilson, MD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for individuals with Opioid Use Disorder who may also be at risk of self-harm. Participants should be currently hospitalized and willing to engage with peer support specialists, as well as comfortable receiving and responding to text messages for assessments.

Inclusion Criteria

Participants admitted to University of Pittsburgh Medical Center (UPMC) Shadyside Hospital, UPMC Presbyterian-Montefiore Hospital, UPMC Mercy Hospital for inpatient or observation status, or seen in the Emergency Department setting at UPMC Presbyterian-Montefiore Hospital and UPMC Mercy Hospital

Participants must have a current diagnosis of Opioid Use Disorder based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnostic criteria

Participants must be able to speak and read English

Exclusion Criteria

Participants who are pregnant or lactating at onset of study

I have been diagnosed with dementia or cognitive impairments.

Participants with acute psychiatric complications such as schizophrenia with acute psychosis, acute mania, or suicidal ideation

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive one in-person session from a peer support specialist while in the hospital and weekly text messages for 12 weeks

12 weeks

1 visit (in-person), weekly text messages

Assessment

Participants complete monthly multiple-choice assessments via text message and baseline, 3-month, and 6-month assessments with Research Assistants

6 months

Monthly assessments (virtual), 3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Treatment Details

Interventions

• THRIVE Intervention

Trial Overview The THRIVE intervention, which includes a one-time in-person session with a peer specialist, weekly follow-up texts for 12 weeks, and regular text message assessments over six months, is being tested against enhanced usual care that provides harm reduction resources without the personalized support.

Participant Groups

Group I: Peer Intervention Experimental Treatment 1 Intervention

Group II: Enhanced Usual Care Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

A 20-minute telephone-delivered peer recovery support service (PRSS) intervention led to a higher enrollment in medication for opioid use disorder (MOUD) among participants, with 32.5% of PRSS participants enrolling compared to 17.5% in the control group.

Participants receiving PRSS were significantly less likely to experience an opioid overdose (OOD) within 12 months, with only 12.5% reporting an OOD compared to 32.5% in the control group, indicating the potential effectiveness of PRSS in enhancing safety for individuals with opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial. Winhusen, T., Wilder, C., Kropp, F., et al.[2022]

A qualitative study involving 26 patients receiving methadone treatment found that a peer recovery specialist-delivered behavioral activation intervention (Peer Activate) was perceived as acceptable and feasible, particularly due to its flexibility and the supportive qualities of the peer specialists.

Participants highlighted the importance of connecting with the intervention content and building skills, while also noting stigma related to substance use and methadone treatment as barriers to engagement, suggesting that addressing these issues could enhance treatment retention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"You rise up and then you start pulling people up with you": Patient experiences with a peer-delivered behavioral activation intervention to support methadone treatment. Kleinman, MB., Hines, AC., Anvari, MS., et al.[2023]

Peer support models have been effective in helping individuals with opioid use disorder (OUD) start treatment and reduce relapse rates, highlighting their potential in addressing the opioid crisis.

Integrating peer coaches into online interventions within community settings shows promise for engaging people with OUD, suggesting a novel approach to enhance treatment accessibility and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of Peer Coaches in Digital Interventions for MOUD Initiation and Maintenance. Garett, R., Young, SD.[2023]

Peer recovery support services (PRSS) have been integrated into the recovery process for opioid use disorder (OUD), but their effectiveness on clinical outcomes remains unclear, as only 12 out of 123 studies met the inclusion criteria for review.

Most studies reported on PRSS engagement and medication for OUD (MOUD) initiation, but findings were inconsistent and varied due to the lack of standardized PRSS interventions and methodological limitations, indicating a need for further research before widespread implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of peer recovery support services on stages of the opioid use disorder treatment cascade: A systematic review. Gormley, MA., Pericot-Valverde, I., Diaz, L., et al.[2022]

The Peer Activate intervention, delivered by peer recovery specialists, showed high feasibility and acceptability, with 86.5% of participants initiating the program and 81.3% completing at least 75% of sessions, indicating strong engagement among low-income, minoritized populations.

Participants in the Peer Activate program had a significantly higher retention rate in methadone treatment (88.6%) compared to those receiving standard treatment, along with improved adherence to methadone and reduced substance use frequency, highlighting the potential effectiveness of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer recovery specialist-delivered, behavioral activation intervention to improve retention in methadone treatment: Results from an open-label, Type 1 hybrid effectiveness-implementation pilot trial. Magidson, JF., Kleinman, MB., Bradley, V., et al.[2023]

A new model for treating opioid use disorder (OUD) called the Recovery Community Center Office-Based Opioid Treatment model is proposed to enhance care and reduce overdose risks, building on recent community-based innovations.

The model includes specific protocols for responding to overdose and non-overdose events, but faces potential barriers such as reimbursement issues and regulatory challenges that need to be addressed in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Responding to the opioid and overdose crisis with innovative services: The recovery community center office-based opioid treatment (RCC-OBOT) model. Ashford, RD., Brown, AM., McDaniel, J., et al.[2020]

This study will evaluate the effectiveness of behavioral interventions for opioid use disorder (OUD) delivered by certified peer recovery support specialists versus licensed clinical social workers (LCSWs) in a randomized trial involving 650 high-risk patients over 18 months.

The primary goals are to measure how well these interventions promote engagement in OUD treatment within 30 days and reduce recurrent emergency department visits for opioid overdose within 18 months, providing valuable insights into effective treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised clinical trial of an emergency department-based peer recovery support intervention to increase treatment uptake and reduce recurrent overdose among individuals at high risk for opioid overdose: study protocol for the navigator trial. Goedel, WC., Marshall, BDL., Samuels, EA., et al.[2023]

A pilot randomized controlled trial involving 25 hospitalized adults with opioid use disorder (OUD) tested a peer recovery coach intervention to improve retention in medications for opioid use disorder (MOUD) after discharge.

The study found no significant differences in MOUD retention rates, hospital readmissions, or time to treatment discontinuation between the recovery coach intervention group and the treatment-as-usual group, indicating that the intervention did not enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. Suzuki, J., Martin, B., Loguidice, F., et al.[2023]

A study involving 32 participants indicated that a peer recovery specialist-delivered behavioral activation intervention could be both feasible and acceptable for supporting retention in methadone treatment for opioid use disorder.

Participants highlighted the potential of this intervention to address challenges related to unstructured time in treatment, suggesting that peer support could enhance engagement and outcomes for underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Sometimes you have to take the person and show them how": adapting behavioral activation for peer recovery specialist-delivery to improve methadone treatment retention. Kleinman, MB., Anvari, MS., Bradley, VD., et al.[2023]

A survey of 129 peer recovery coaches in Massachusetts revealed that the majority have positive attitudes toward medications for opioid use disorder (MOUDs), viewing them as effective treatments for achieving sobriety.

Coaches with personal experience of opioid use disorder and MOUD treatment were more supportive of working with patients on methadone, while those without such experiences tended to favor drug-free treatments and shorter MOUD durations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Attitudes Regarding Medications for Opioid Use Disorder Among Peer Recovery Coaches. Suzuki, J., Loguidice, F., Martin, B.[2023]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

A brief telephone-delivered peer intervention to encourage enrollment in medication for opioid use disorder in individuals surviving an opioid overdose: Results from a randomized pilot trial. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

"You rise up and then you start pulling people up with you": Patient experiences with a peer-delivered behavioral activation intervention to support methadone treatment. [2023]

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

Role of Peer Coaches in Digital Interventions for MOUD Initiation and Maintenance. [2023]

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

Effectiveness of peer recovery support services on stages of the opioid use disorder treatment cascade: A systematic review. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Peer recovery specialist-delivered, behavioral activation intervention to improve retention in methadone treatment: Results from an open-label, Type 1 hybrid effectiveness-implementation pilot trial. [2023]

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

Responding to the opioid and overdose crisis with innovative services: The recovery community center office-based opioid treatment (RCC-OBOT) model. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Randomised clinical trial of an emergency department-based peer recovery support intervention to increase treatment uptake and reduce recurrent overdose among individuals at high risk for opioid overdose: study protocol for the navigator trial. [2023]

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

A Peer Recovery Coach Intervention for Hospitalized Patients with Opioid Use Disorder: A Pilot Randomized Controlled Trial. [2023]

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

"Sometimes you have to take the person and show them how": adapting behavioral activation for peer recovery specialist-delivery to improve methadone treatment retention. [2023]

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

Attitudes Regarding Medications for Opioid Use Disorder Among Peer Recovery Coaches. [2023]