Peer Support for Polysubstance Abuse

(PRISM Trial)

Recruiting at 3 trial locations

Overseen By Sarah M Kattakuzhy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, College Park

Must be taking: Opioid use disorder medications

Disqualifiers: Unstable psychiatric symptoms, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to help individuals with opioid use disorder adhere to their treatment and reduce the use of multiple substances. It employs a peer-led intervention called "Peer Activate," where trained individuals who have experienced recovery provide support. Participants will be randomly assigned to either the Peer Activate group or continue with their usual treatment methods to evaluate the effectiveness of peer support over a year. The trial seeks participants receiving opioid treatment through telemedicine who have used other substances (excluding opioids or tobacco) in the past three months. As an unphased trial, this study offers a unique opportunity to contribute to innovative treatment methods that could enhance recovery support for many.

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 focuses on improving adherence to medication for opioid use disorder and reducing polysubstance use.

What prior data suggests that this peer-led behavioral intervention is safe?

Research has shown that peer-delivered behavioral activation, a therapy used in this trial, may assist individuals with substance use disorders. In this treatment, trained peers help others engage in positive activities and reduce drug use. Studies suggest that this approach is generally well-tolerated, with most participants not experiencing major side effects.

Detailed safety data is limited because this therapy does not involve new medications. Instead, it employs behavioral strategies, which are typically considered safe. Since the trial focuses on a support method rather than a new drug, it is unlikely to carry the safety risks often associated with medications.

Overall, based on current knowledge, this type of intervention appears safe, especially when compared to traditional drug-based treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Peer-Delivered Behavioral Activation, also known as "Peer Activate," because it offers a unique approach to tackling polysubstance abuse. Unlike traditional treatments that mainly focus on medical interventions like methadone maintenance, Peer Activate emphasizes behavioral activation facilitated by peers who have walked similar paths. This peer-driven method aims to enhance retention in methadone programs and reduce substance use by directly addressing barriers and increasing positive, substance-free experiences. By leveraging the power of peer support and personal experience, this treatment could provide more relatable and effective reinforcement for individuals struggling with polysubstance use.

What evidence suggests that Peer Activate is effective for polysubstance abuse?

This trial will compare Peer-Delivered Behavioral Activation, known as "Peer Activate," with Treatment As Usual for addressing polysubstance abuse. Research has shown that peer assistance in certain activities can reduce substance use problems. One study found that participants experienced fewer issues with substance use after receiving this type of help. Another study examined perceptions of this method and found it suitable for addressing substance use problems. These findings suggest that peer support can help individuals adhere to medication plans and reduce the use of multiple substances. Overall, the evidence indicates potential benefits of using peer support for those facing substance use challenges. ^{6 7 8 9 10}

Who Is on the Research Team?

Jessica F Magidson, PhD

Principal Investigator

University of Maryland, College Park

Sarah Kattakuzhy, MD

Principal Investigator

University of Maryland, Baltimore

Are You a Good Fit for This Trial?

This trial is for adults over 18 with opioid use disorder and polysubstance use in a rural area, who have struggled to stick to their medication plan or haven't refilled their pharmacy prescription recently. It's not for those with untreated severe mental health issues or pregnant individuals.

Inclusion Criteria

I am getting treatment for opioid use disorder through a telemedicine program.

Exhibit polysubstance use within the past three months (i.e., use of one or more non-prescribed substances excluding opioids and/or tobacco by urine toxicology or self-report)

Exclusion Criteria

Positive pregnancy status at enrollment

Inability to understand the study and provide informed consent in English

Demonstrating active, unstable or untreated psychiatric symptoms, including mania and/or psychosis that would interfere with study participation

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a peer-delivered behavioral activation intervention to improve adherence to medication for opioid use disorder and reduce polysubstance use

12 months

Regular meetings with PRS and addiction medicine physician

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• Peer-Delivered Behavioral Activation

Trial Overview The study tests 'Peer Activate,' a peer-led program aiming to improve adherence to opioid addiction medications and reduce the use of multiple substances. Participants will either receive this new intervention or the usual treatment, and they'll be followed for twelve months.

How Is the Trial Designed?

Group I: Peer-Delivered Behavioral Activation ("Peer Activate") Experimental Treatment 1 Intervention

Participants in the Peer Activate intervention will receive a PRS-delivered behavioral activation intervention to address barriers to retention in methadone treatment and increase substance-free, positive reinforcement to support retention and reduce polysubstance use.

Group II: Treatment As Usual Active Control 1 Intervention

Participants in the TAU group will receive enhanced treatment as usual, defined as MTU services as usual enhanced with additional community referrals and follow-ups on those referrals, in addition to regular meetings with an addiction medicine physician and PRS on the MTU. Standard PRS contact typically includes connection to local resources and general peer support as needed.

Who Is Running the Clinical Trial?

University of Maryland, College Park

Lead Sponsor

Trials

163

Recruited

46,800+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Weill Medical College of Cornell University

Collaborator

Trials

1,103

Recruited

1,157,000+

Published Research Related to This Trial

Peer recovery support services are increasingly recognized as valuable in treating substance use disorders, offering a broader range of support than traditional mutual support groups.

The literature review highlights the need for more research to clearly differentiate the specific benefits of peer recovery support services from other recovery activities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer recovery support for individuals with substance use disorders: assessing the evidence. Reif, S., Braude, L., Lyman, DR., et al.[2015]

Peer recovery support services (PRSS) show promise in improving outcomes for individuals with substance use disorder (SUD), including reduced substance use, lower relapse rates, and increased treatment satisfaction, based on a systematic review of various studies.

However, the existing research has significant methodological limitations, such as inconsistent definitions of peer roles and a lack of appropriate comparison groups, highlighting the need for more rigorous studies to better understand the efficacy and implementation of PRSS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lived Experience in New Models of Care for Substance Use Disorder: A Systematic Review of Peer Recovery Support Services and Recovery Coaching. Eddie, D., Hoffman, L., Vilsaint, C., et al.[2023]

A study involving 30 clients with problematic substance use and 11 community providers in Baltimore found that a peer recovery coach (PRC)-delivered behavioral activation (BA) intervention could be perceived as acceptable and appropriate for individuals not currently engaged in care.

Participants suggested that adapting the BA intervention to include peer-delivered case management and community-specific activities could enhance its effectiveness in addressing substance use issues among low-income, racial/ethnic minority groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting a peer recovery coach-delivered behavioral activation intervention for problematic substance use in a medically underserved community in Baltimore City. Satinsky, EN., Doran, K., Felton, JW., et al.[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 brief two-hour training significantly improved the competency of peer recovery specialists (PRSs) in delivering behavioral activation, indicating that such training can effectively enhance their skills in evidence-based interventions.

Experience as a PRS was a significant predictor of improved skills in behavioral activation after training, suggesting that more experienced PRSs may benefit more from such training, although no specific characteristics were found to predict overall PRS competence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Pilot Study of Training Peer Recovery Specialists in Behavioral Activation in the United States: Preliminary Outcomes and Predictors of Competence. Anvari, MS., Kleinman, MB., Dean, D., et al.[2023]

Individuals with disabilities may have higher rates of opioid and substance use disorders, highlighting the need for tailored treatment approaches, such as peer support.

Key themes for effective peer support include ensuring accessibility, matching peers appropriately, and focusing on recruitment and training, which are crucial for meeting the unique needs of this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer Support at the Intersection of Disability and Opioid (Mis)Use: Key Stakeholders Provide Essential Considerations. Nicholson, J., Valentine, A., Ledingham, E., 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]

Citations

1. cesar.umd.edu cesar.umd.edu/landingtopic/detroit-peer-recovery

Hybrid Effectiveness-Implementation Trial to Evaluate a ... This study aims to test how a peer-delivered behavioral activation approach can simultaneously address both substance use and depression outcomes.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9590100/

Peer recovery specialist-delivered, behavioral activation ... Results suggest non-significant decreases in total problems associated with substance use from baseline (M = 27.03, SD = 13.91) to post-intervention (M = 20.96, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6993963/

Adapting a peer recovery coach-delivered behavioral ... The aim of this study was to assess perceptions of the appropriateness of a PRC-delivered adapted behavioral activation (BA) intervention to reduce problematic ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955395923002815

Patient experiences with a peer-delivered behavioral ... This qualitative study sought to explore patient perspectives on receiving an adapted PRS-delivered behavioral activation intervention (Peer Activate) to ...

5. trial.medpath.com trial.medpath.com/clinical-trial/4b50d01733ce7130/nct07219394-peer-delivered-intervention-depression-substance-use-disorder

Peer-Delivered Behavioral Activation in a CCBHC | MedPath This study will examine the effectiveness and implementation potential of a peer-delivered evidence-based intervention (Behavioral Activation) ...

6. reporter.nih.gov reporter.nih.gov/search/Au2AYliZFkKjTRmE-WlMfQ/project-details/9314676

Initiating substance use disorder treatment in hospitalized ... Psychiatry residents' and fellows' confidence and knowledge in interpreting urine drug testing results related to opioids. Substance abuse2018; 39 (4) 518-521.

7. heal.nih.gov heal.nih.gov/funding/awarded?advancedSearch=false&combine=overdose&goal=All&grant=All&institutions1=&institutions=&items_per_page=25&locations1=&locations=&research_program=All&rfa=All&select_location=All&year=&page=19&order=field_year_awarded&sort=asc

Funded Projects | NIH HEAL Initiative Young adults (18 to 26) with a substance use problem have the highest rates of polysubstance use among all age groups. At the same time, individuals in this age ...

8. researchgate.net researchgate.net/publication/325345963_Randomized_Clinical_Trial_of_Computerized_and_Clinician-Delivered_CBT_in_Comparison_With_Standard_Outpatient_Treatment_for_Substance_Use_Disorders_Primary_Within-Treatment_and_Follow-Up_Outcomes

Randomized Clinical Trial of Computerized and Clinician ... CBT is a time-limited, multisession strategy that targets cognitive, affective, and environmental risks for substance abuse and teaches ...

9. ascpjournal.biomedcentral.com ascpjournal.biomedcentral.com/articles/10.1186/s13722-020-00208-4

Proceedings of the Addiction Health Services Research ... The Substance Abuse Treatment to HIV Care Project was funded to test an organization-focused strategy called Implementation & Sustainment ...

10. withpower.com withpower.com/trial/phase-opioid-medication-assisted-treatment-2-2022-af50a

Peer-Delivered Behavioral Activation for Opioid Addiction · ... ... Medication Treatment, Retention in Care, Substance Abuse, Opioid Use Disorder, Thalassemia, Opioid Use Disorder and Drug Addiction. Learn more about the study.