Peer-Delivered Behavioral Activation for Opioid Addiction

(HEAL Together Trial)

No longer recruiting at 1 trial location

Overseen By Aaron Greenblatt, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, College Park

Must be taking: Methadone

Disqualifiers: Unstable psychiatric symptoms, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and feasibility of a peer-led program in helping individuals adhere to their medication for opioid use disorder (OUD). It focuses on a behavioral method called behavioral activation, delivered by trained peers, to support individuals in maintaining their methadone treatment. Participants will either try this new peer-led approach, known as Peer-Delivered Behavioral Activation, or continue their usual treatment, which includes regular counseling sessions. This trial may suit individuals in Baltimore who have been on methadone for less than three months or have recently struggled with their treatment plan. As an unphased trial, this study offers a unique opportunity to explore innovative support methods for OUD treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it focuses on improving adherence to methadone, a medication for opioid use disorder. It seems likely that you will continue taking methadone during the study.

What prior data suggests that this behavioral intervention is safe?

Research shows that Peer-Delivered Behavioral Activation is generally safe. In previous studies, participants handled the treatment well, and no serious side effects were reported. This approach involves trained peers assisting others with activities to boost motivation and support medication adherence for opioid use disorder. The goal is to help individuals stick to their treatment plans and make positive life changes. Since this treatment does not involve drugs, it carries lower risks compared to medication-based treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Peer-Delivered Behavioral Activation for opioid addiction because it offers a unique approach by involving peers in the treatment process. Unlike traditional methods that rely heavily on professional counseling and medication like methadone, this approach uses trained peers to deliver behavioral activation interventions. This peer involvement aims to directly address barriers to staying in treatment and create more positive, substance-free activities, potentially improving retention and outcomes in methadone treatment. By focusing on building supportive, real-world connections, this method could enhance treatment adherence and foster recovery in a relatable and empowering way.

What evidence suggests that Peer-Delivered Behavioral Activation is effective for opioid addiction?

Research has shown that support from peer recovery specialists can help people continue methadone treatment for opioid addiction. In this trial, participants in the Peer-Delivered Behavioral Activation ("Peer Activate") arm will receive a peer-led intervention designed to address barriers to retention in methadone treatment and encourage positive, drug-free activities. One study found that 88.6% of participants remained in treatment three months after starting this peer-led support, nearly 29% more than those without this help. Early results suggest this method can greatly improve adherence to medication for opioid use disorder (MOUD). ^{1 2 3 6 7}

Who Is on the Research Team?

Jessica F Magidson, PhD

Principal Investigator

University of Maryland, College Park

Are You a Good Fit for This Trial?

This trial is for adults over 18 in Baltimore with opioid use disorder who have started methadone treatment at the study site within the last three months or have had trouble sticking to their methadone regimen. It's not for those with untreated severe mental health issues, non-English speakers, or pregnant individuals.

Inclusion Criteria

I started methadone recently or had trouble following my methadone treatment.

Exclusion Criteria

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

Positive pregnancy status at enrollment

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 methadone treatment

6 months

Weekly sessions

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 'Peer Activate' program, led by peer recovery specialists using behavioral activation techniques, aims to improve how well participants stick to their medication-assisted treatment for opioid addiction compared to usual care. The effectiveness and implementation will be studied over six 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.

Group II: Treatment As Usual Active Control 1 Intervention

Participants in the TAU group will receive treatment as usual (weekly group and individual counseling with an addiction counselor in addition to referral to other available services in the community through study contact).

Who Is Running the Clinical Trial?

University of Maryland, College Park

Lead Sponsor

Trials

163

Recruited

46,800+

Henry Ford Health System

Collaborator

Trials

334

Recruited

2,197,000+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

Published Research Related to This Trial

Patient activation, which involves actively participating in treatment decisions and taking responsibility for recovery, is crucial for positive outcomes in individuals with opioid use disorder (OUD) in intensive outpatient treatment (IOT) programs, as identified through interviews with 14 participants.

The study identified six key types of patient activation behaviors, highlighting the importance of collaboration with staff and self-determination in recovery, suggesting that IOT programs should foster these active roles while being cautious about the timing of certain interventions to avoid hindering recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Activation of Persons With Opioid Use Disorder in Intensive Outpatient Treatment. Keen, A., Lu, Y., Oruche, UM., et al.[2022]

The HEROES program successfully engaged 324 individuals with opioid use disorder, with 90.43% completing the 30-day treatment that included buprenorphine and behavioral support.

After the program, 63% of participants were linked to ongoing treatment, and there was a significant 36% improvement in health-related quality of life, indicating the program's effectiveness in retaining patients in care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes from an integrated bridge treatment program for opioid use disorder. Langabeer, JR., Champagne-Langabeer, T., Yatsco, AJ., et al.[2022]

Emergency department-based peer support programs are effective in connecting individuals with opioid use disorder (OUD) to medication and recovery services, showing promise in addressing the opioid crisis.

The integration of peer support varies across programs, affecting how peers are alerted to potential patients and how they engage with them, highlighting the need for consistent reporting on these methods in future evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emergency department-based peer support for opioid use disorder: Emergent functions and forms. McGuire, AB., Powell, KG., Treitler, PC., et al.[2021]

Patients receiving methadone treatment reported experiencing various forms of stigma related to substance use and medication, which significantly hindered their retention in opioid use disorder treatment programs.

Peer recovery specialists (PRSs), who share similar experiences with substance use and recovery, have the potential to reduce stigma and improve retention in medication for opioid use disorder by leveraging their unique perspectives and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"In their mind, they always felt less than": The role of peers in shifting stigma as a barrier to opioid use disorder treatment retention. Anvari, MS., Kleinman, MB., Massey, EC., et al.[2023]

The use of reSET-O, a digital therapeutic for patients undergoing buprenorphine medication-assisted treatment for opioid use disorder, led to a significant reduction in healthcare encounters, including 45 fewer inpatient visits and 27 fewer emergency department visits over six months among 351 patients.

Patients also experienced a net cost savings of $2,150 per person, indicating that reSET-O not only improved treatment adherence but also reduced overall healthcare costs associated with opioid use disorder management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic. Velez, FF., Colman, S., Kauffman, L., et al.[2022]

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]

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 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 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]

Citations

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

Peer recovery specialist-delivered, behavioral activation ... Preliminary results show promise for both the implementation and effectiveness of PRS-delivered behavioral activation to improve retention in methadone ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04248933

Peer-Delivered Behavioral Activation for Methadone ... The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0955395922002298

Peer recovery specialist-delivered, behavioral activation ... For effectiveness outcomes, 88.6% of participants in Peer Activate were retained in methadone treatment at three-months post-intervention—28.9% higher than ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05299515

Trial of Peer-Delivered Behavioral Activation for ... The purpose of this study is to evaluate the feasibility and effectiveness of a peer-led, brief, behavioral intervention to improve adherence to medication ...

5. cesar.umd.edu cesar.umd.edu/landingtopic/heal-peer-delivered-behavioral-intervention

HEAL: Peer-Delivered Behavioral Intervention to Improve ... Aims: We will evaluate the effectiveness and implementation of Peer Activate on MOUD retention at six months (primary), MOUD adherence and substance use changes ...

6. frontiersin.org frontiersin.org/journals/public-health/articles/10.3389/fpubh.2025.1637846/full

“HEAL together”: a randomized, hybrid type 1 effectiveness ... This trial will provide insight as to whether a PRS-delivered intervention may be effective and feasible for improving methadone treatment retention.

7. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-023-00524-3

adapting behavioral activation for peer recovery specialist ... A peer recovery specialist-delivered behavioral activation intervention supporting retention in methadone treatment by increasing positive reinforcement.