Pilot Study of Methadone Patient Access to Collaborative Treatment: a HEAL Initiative

NCT06513728 | Completed DMC

• 1 other identifier: 456482
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation.

Conditions

Opioid Substitution Treatment Clinics; Patients; Staff

Keywords

Implementation Science; Methadone treatment; Opioid Use Disorder; Opioid Use Disorder Treatment; Workforce Development; Vicarious trauma; Posttraumatic stress; Treatment retention

Outcome Measures

Primary Outcomes (2)

• methadone treatment retention

  Retention in methadone treatment (measured by 3 different indicators)

  4 months (pilot study period)

• In treatment overdose

  Reported overdoses during methadone treatment (measured by study constructed algorithm)

  4 months (pilot study period)

Secondary Outcomes (2)

• Trauma symptoms among patients and staff

  pilot period of 4 months

• Vicarious Trauma symptoms among staff

  pilot period of 4 months

Study Arms (1)

MPACT Intervention

EXPERIMENTAL

Single arm study. All sites will receive the intervention.

Other: MPACT Intervention

Interventions

MPACT Intervention OTHER

MPACT has 4 components: accredited training about patient centered, trauma informed methadone treatment, staff education about trauma symptoms with navigation to self screening and treatment or stress management, clinic self assessment tools for trauma informed, patient centered care, and reflective supervision for counselors, case managers and peer staff.

MPACT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Staff of enrolled opioid treatment programs (methadone clinics) who are involved with methadone treatment
• Patients receiving methadone at these locations

You may not qualify if:

• Patients not receiving methadone at these locations
• Staff not involved in methadone treatment at these locations

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona College of Medicine

Tucson, Arizona, 85714, United States

Location

Related Publications (1)

• Meyerson BE, Davis A, Crosby RA, Linde-Krieger LB, Brady BR, Carter GA, Mahoney AN, Frank D, Rothers J, Coffee Z, Deuble E, Ebert J, Jablonsky MF, Juarez M, Lee B, Lorenz HM, Pava MD, Tinsely K, Yousaf S. Methadone Patient Access to Collaborative Treatment: Protocol for a Pilot and a Randomized Controlled Trial to Establish Feasibility of Adoption and Impact on Methadone Treatment Delivery and Patient Outcomes. JMIR Res Protoc. 2025 Apr 15;14:e69829. doi: 10.2196/69829.

  PMID: 40105313 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Compassion Fatigue

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Mental Fatigue; Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Occupational Stress; Stress, Psychological

Study Officials

• Beth Meyerson, PhD

  Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a pilot implementation and preliminary effectiveness study of MPACT.

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 22, 2024
• Study Start: September 26, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: August 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: 1 year after the study completion
• Access Criteria: See Data sharing and management plan

Locations

US (1)