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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new support program called the THRIVE intervention to assist individuals with opioid use disorder. The researchers aim to determine if peer support specialists can reduce the likelihood of non-fatal overdoses or skin infections compared to standard care information alone. Participants in the THRIVE group will attend sessions with a peer support specialist and receive regular text check-ins. Eligible participants have been diagnosed with opioid use disorder and are receiving care at specific hospitals in Pittsburgh. As an unphased trial, this study offers participants the opportunity to contribute to innovative approaches in managing opioid use disorder.

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 prior data suggests that the THRIVE intervention is safe?

Research has shown that educational programs about opioid use can be helpful. Four studies found that participants gained knowledge and developed better attitudes about opioid use. Two additional studies demonstrated that participants understood the risks of opioid withdrawal and overdose much better after these programs.

The THRIVE program supports people with opioid use disorder through peer support. As a harm reduction service, it aims to reduce risks like overdoses and infections. However, these sources do not provide specific safety data for THRIVE itself.

Since this trial is not in the early stages, it suggests that THRIVE has undergone previous testing and is likely considered safe enough for further study. The focus is more on its effectiveness, not just its safety. While specific safety data for THRIVE isn't mentioned here, its testing in this trial phase suggests it has a reasonable safety profile. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the THRIVE Intervention for opioid use disorder because it takes a novel peer-led approach. Unlike traditional treatments that often rely on medication-assisted therapies like methadone or buprenorphine, THRIVE leverages the power of peer support, which can foster a sense of community and shared understanding among participants. This approach is promising because it not only addresses the physical aspects of addiction but also the psychological and social factors, potentially leading to more holistic and sustainable recovery paths.

What evidence suggests that the THRIVE intervention is effective for reducing non-fatal overdoses or skin/soft tissue infections?

Research has shown that the THRIVE program, available to participants in the Peer Intervention arm of this trial, might help reduce non-fatal overdoses and skin or soft tissue infections in individuals with opioid use disorder. One study found that peer support can improve health by sharing personal experiences and advice. Additionally, harm reduction methods, like those in THRIVE, have been linked to fewer health problems in similar contexts. Early results suggest that a peer support specialist can boost motivation and provide important information about safer practices. Overall, these factors make THRIVE a promising approach to managing health issues related to opioid use. ^{1 4 6 7 8}

Who Is on the Research Team?

Jacqueline D Wilson, MD

Principal Investigator

University of Pennsylvania

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06843213

Teaching Harm Reduction in a Hospital Setting: A Peer-led ... Effectiveness of the THRIVE intervention compared to enhanced usual care (EUC) at lowering the incidence of non-fatal overdoses OR skin and soft tissue ...

2. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06348-0

Study protocol for a randomized controlled trial to adapt a ... Evidence suggests that PSU complicates treatment outcomes [16,17,18,19,20]. This effect may be particularly acute for individuals receiving ...

3. mgriblog.org mgriblog.org/2024/05/28/pilot-study-shows-promise-of-vr-in-improving-treatment-for-opioid-withdrawal/

Pilot Study Shows Promise of Virtual Reality in Improving ... Patients who participated in two VR sessions during treatment for opioid withdrawal were more likely to complete their treatment protocol.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06609278

THRIVE: Culturally AdapTed Harm Reduction Intervention | ... The overall study design is a mixed methods pilot developing and testing a culturally adapted intervention to enhance knowledge about and motivation to use ...

5. researchgate.net researchgate.net/publication/378682754_A_pilot_study_of_virtual_reality_for_inpatients_with_opioid_use_disorder

A pilot study of virtual reality for inpatients with opioid use ... Compared to baseline, 3DTT participants reported significant reductions in depression, tension, and cravings ( p 's < 0.001). Discussion and Conclusions This ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10993074/

Public Health Interventions and Overdose-Related ... This decision analytical model estimates the projected 3-year association between public health interventions and opioid overdose-related outcomes

7. sciencedirect.com sciencedirect.com/science/article/pii/S0306460325000231

Effectiveness of educational interventions in United States ... Four studies showed improved knowledge and attitudes towards opioid use and two showed increased understanding of opioid withdrawal and overdose ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7801772/

Three-month outcomes from a patient-centered program to ... All study participants received treatment for opioid use disorder, but 40 % of participants in this study reported no illicit drug use in the 30 days prior to ...