NCT04248933: HEAL Together

Peer-Delivered Behavioral Activation for Methadone Adherence - Pilot Phase

Completed NA Results posted Last updated 2 December 2022

What this trial tests

NA trial testing Peer-Delivered Behavioral Activation (Peer Activate) in Substance Use in 37 participants. Completed in 31 January 2022.

Timeline

9 October 2020

Primary endpoint
19 October 2021

31 January 2022

Quick facts

Lead sponsor	University of Maryland, College Park
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	37
Start date	9 October 2020
Primary completion	19 October 2021
Estimated completion	31 January 2022
Sites	2 locations across United States

Drugs / interventions tested

• Peer-Delivered Behavioral Activation (Peer Activate)

Conditions studied

• Substance Use — all drugs for Substance Use →
• Substance Use Disorders — all drugs for Substance Use Disorders →
• Opioid-use Disorder — all drugs for Opioid-use Disorder →
• Peer Delivered — all drugs for Peer Delivered →

Sponsor

University of Maryland, College Park

Who can join

18 and older, any sex, with Substance Use or Substance Use Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

MOUD Retention Rate: % of Patients Retained at 3 Months Primary · Measured daily from intake to post-treatment (approximately 12-weeks)

Percent of patients retained in MOUD treatment at three months (i.e. still engaged in care) after intervention enrollment.

Group	Value	95% CI
Peer-Delivered Behavioral Activation ("Peer Activate")	31

Intervention Feasibility: % of Patients Who Agree to Participate in the Intervention Primary · Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)

Feasibility, defined as the suitability and practicability of the approach, was measured quantitatively as the % of patients who agreed to participate in the intervention.

Group	Value	95% CI
Peer-Delivered Behavioral Activation ("Peer Activate")	32

Intervention Acceptability: % of Patients Who Attend ≥75% Sessions Secondary · Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)

Acceptability, defined as satisfaction with or tolerability of the proposed approach, was measured quantitatively by session attendance. Specifically, we measured the % of patients who attended ≥75% of core intervention sessions.

Group	Value	95% CI
Peer-Delivered Behavioral Activation ("Peer Activate")	26

Intervention Fidelity: Percentage of Intervention Components Delivered by Peer as Intended Secondary · Assessed between the baseline assessment and the acute outcome (approximately 12-weeks post-baseline assessment/ post-treatment assessment)

Fidelity, defined as the delivery of the intervention as intended, was measured based on PRS adherence to the intervention delivery. A random selection of 20% of sessions was rated for fidelity, and we assessed the % of intervention components delivered as intended.

Group	Value	95% CI
Peer-Delivered Behavioral Activation ("Peer Activate")	87.9	± 18.0

Adverse events — posted to ClinicalTrials.gov

Time frame: Assessed between the baseline assessment and the acute outcome (approximately 12 weeks post-baseline assessment/ post-treatment assessment).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Peer-Delivered Behavioral Activation ("Peer Activate")

Serious: 11/37 (30%)

Deaths: 0/37

Serious adverse events (5 terms)

Reaction	System	Peer-Delivered Behavioral …
Hospitalization	Injury, poisoning and procedural complications	—
Hospitalization	Infections and infestations	—
Hospitalization	General disorders	—
Hospitalization	Psychiatric disorders	—
Hospitalization	Respiratory, thoracic and mediastinal disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	Peer-Delivered Behavioral …
Medical event	Injury, poisoning and procedural complications	—
Medical event	Respiratory, thoracic and mediastinal disorders	—
Medical event	General disorders	—

Most-reported serious reactions: Hospitalization, Hospitalization, Hospitalization, Hospitalization, Hospitalization.

Data from ClinicalTrials.gov NCT04248933 adverse events section.

Sponsor's own description

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) among low-income, minoritized individuals living with opioid use disorder (OUD) in Baltimore, Maryland. The intervention is based on behavioral activation (BA) and is specifically designed to be implemented by a trained peer recovery specialist. In this pilot trial, the investigators will evaluate the feasibility, acceptability, and fidelity of this approach (implementation outcomes) and preliminary effectiveness on methadone treatment retention at three months.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. "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, Bradley VD, et al · · 2022 · cited 51× · PMID 35067397 · DOI 10.1016/j.jsat.2022.108721
2. 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, Anvari MS, et al · · 2022 · cited 21× · PMID 35932644 · DOI 10.1016/j.drugpo.2022.103813
3. Reduction in substance use stigma following a peer-recovery specialist behavioral activation intervention.
   Kleinman MB, Anvari MS, Felton JW, Bradley VD, et al · · 2024 · cited 9× · PMID 39003894 · DOI 10.1016/j.drugpo.2024.104511
4. "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, Felton JW, et al · · 2023 · cited 8× · PMID 36879304 · DOI 10.1186/s13011-023-00524-3
5. "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, Bradley VD, et al · · 2023 · cited 3× · PMID 37866292 · DOI 10.1016/j.drugpo.2023.104234
6. Substance use stigma mechanisms associated with greater depressive symptoms, substance use-related problems, and lower behavioral activation.
   Anvari MS, Sacko CA, Triplett NS, Bradley VD, et al · · 2026 · PMID 42256591 · DOI 10.1016/j.abrep.2026.100705