Peer-Delivered Behavioral Activation for Opioid Addiction

(HEAL Together Trial)

Recruiting at1 trial location

Overseen by Jessica F Magidson, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of Maryland, College Park

Must be taking: Methadone

Disqualifiers: Unstable psychiatric symptoms, Pregnancy, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests if trained peers can help low-income, minority individuals with opioid addiction stick to their medication by encouraging positive activities. The goal is to see if this approach improves medication adherence.

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 data supports the effectiveness of the treatment Peer-Delivered Behavioral Activation for Opioid Addiction?

Research suggests that peer recovery specialists, who have personal experience with substance use and recovery, can effectively deliver behavioral activation (a therapy that helps people engage in positive activities) to support patients in methadone treatment for opioid addiction. This approach, called Peer Activate, has shown promise in improving retention in treatment, which is crucial for recovery success. ^{1 2 3 4 5}

Is Peer-Delivered Behavioral Activation safe for humans?

The research does not specifically mention safety concerns related to Peer-Delivered Behavioral Activation, suggesting it is generally considered safe when delivered by trained peer recovery specialists. ^{1 2 6 7 8}

How is the Peer-Delivered Behavioral Activation treatment different from other treatments for opioid addiction?

This treatment is unique because it involves peer recovery specialists, who have personal experience with addiction and recovery, delivering behavioral activation therapy to support patients in methadone treatment, aiming to improve retention by addressing stigma and providing relatable support. ^{1 2 4 8 9}

Research Team

Jessica F Magidson, PhD

Principal Investigator

University of Maryland, College Park

Eligibility Criteria

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.

I am at least 18 years old.

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

Trial 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 methadone treatment

6 months

Weekly sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• Peer-Delivered Behavioral Activation (Behavioral Intervention)

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.

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.

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+

Kathleen McCollum

University of Maryland, College Park

Chief Executive Officer since 2021

Bachelor's degree from the Wharton School of the University of Pennsylvania, Master of Health Science in Health Finance and Management from Johns Hopkins University School of Hygiene and Public Health

Dr. Jeffrey C. Baker

University of Maryland, College Park

Chief Medical Officer since 2011

MD from Harvard Medical School

Henry Ford Health System

Collaborator

Trials

334

Recruited

2,197,000+

University of Maryland, Baltimore

Collaborator

Trials

729

Recruited

540,000+

Dr. Mohan Suntha

University of Maryland, Baltimore

Chief Executive Officer since 2019

MD from Jefferson Medical College, MBA from Wharton School of Business, BA from Brown University

Dr. Taofeek K. Owonikoko

University of Maryland, Baltimore

Chief Medical Officer

MD, PhD

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]

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]

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]

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 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]

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]

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

Patient Activation of Persons With Opioid Use Disorder in Intensive Outpatient Treatment. [2022]

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

Emergency department-based peer support for opioid use disorder: Emergent functions and forms. [2021]

5. 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]

6. England 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. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Feasibility and outcomes from an integrated bridge treatment program for opioid use disorder. [2022]

9. United States 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. [2023]