Peer Support for Polysubstance Abuse

(PRISM Trial)

Recruiting at 2 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

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication for opioid use disorder (MOUD) and reduce polysubstance use among patients with OUD and polysubstance use in an underserved, rural area. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this hybrid, Type-1 effectiveness-implementation randomized controlled trial (RCT), the investigators will evaluate the effectiveness and implementation of Peer Activate vs. treatment as usual (TAU) over twelve months.

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 data supports the effectiveness of the treatment Peer-Delivered Behavioral Activation for polysubstance abuse?

Research suggests that peer recovery specialists, who have personal experience with substance use, can effectively deliver behavioral activation (a therapy that helps people engage in positive activities) to support individuals in methadone treatment and reduce problematic substance use. This approach has shown promise in improving treatment retention and is considered acceptable and appropriate in underserved communities. ^{1 2 3 4 5}

Is peer-delivered behavioral activation safe for humans?

The studies suggest that peer-delivered behavioral activation is generally considered safe, as it involves trained peers supporting individuals with substance use issues. However, more research is needed to fully understand its safety and effectiveness. ^{1 2 3 5 6}

How is Peer-Delivered Behavioral Activation different from other treatments for polysubstance abuse?

Peer-Delivered Behavioral Activation is unique because it involves trained peer recovery specialists, who have personal experience with substance use and recovery, delivering the treatment. This approach not only provides behavioral activation, which helps individuals engage in positive activities to improve their mood, but also leverages the shared experiences of peers to enhance support and retention in treatment. ^{1 2 3 5 7}

Research Team

Sarah Kattakuzhy, MD

Principal Investigator

University of Maryland, Baltimore

Jessica F Magidson, PhD

Principal Investigator

University of Maryland, College Park

Eligibility Criteria

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)

I am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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]

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]

References

1. 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]

2. 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]

3. United States 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. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Peer Support at the Intersection of Disability and Opioid (Mis)Use: Key Stakeholders Provide Essential Considerations. [2022]

5. Switzerland 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. [2023]

6. Switzerland 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. [2023]

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

Peer recovery support for individuals with substance use disorders: assessing the evidence. [2015]