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

Methadone Patient Access to Collaborative Treatment

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.

Study Overview

• Status: Completed
• Conditions: Patients; Staff; Opioid Substitution Treatment Clinics
• Intervention / Treatment: Other: MPACT Intervention

Detailed Description

Specific AIMS:

AIM 1: Develop MPACT through multilevel, iterative planning with OTP staff and people with recent MMT experience.

AIM 2: Conduct a 4-month MPACT pilot test in two AZ OTPs: Mesa (urban) with 50 patients and 22 staff, and Sierra Vista (rural-serving) with 50 patients and 8 staff to:

1. Determine MPACT implementation feasibility, acceptability, and preliminary effect on MMT practice change and culture.
2. Determine MPACT preliminary effect on MMT retention, in-MMT overdose, and patient PTSS.
3. Characterize staff trauma history, PTSS and vicarious trauma, and explore their relationship with MPACT acceptability and implementation fidelity.

AIM 3: Characterize MPACT acceptability, likely adoption, and recruitment feasibility among directors, case managers and counselors from a national random sample of 500 OTPs.

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85714
      • University of Arizona College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MPACT Intervention; Single arm study. All sites will receive the intervention.	Other: MPACT Intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trauma symptoms among patients and staff	Post traumatic stress symptoms (measured by 8-item Post Traumatic Stress Disorder Checklist or, PCL-5). Scores are 0-80. Higher scores mean greater PTSD symptom severity.	pilot period of 4 months
Vicarious Trauma symptoms among staff	Vicarious trauma symptoms (measured by the Vicarious Trauma Scale (VTS). Scores are 0-190. Higher scores indicate more vicarious (work related) traumatization.	pilot period of 4 months

Collaborators and Investigators

• Sponsor: University of Arizona
• Investigators: Principal Investigator: Beth Meyerson, PhD, PROFESSOR

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: July 16, 2024
• First Submitted That Met QC Criteria: July 16, 2024
• First Posted (Actual): July 22, 2024

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 4, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Opioid Use Disorder; Treatment retention; Implementation Science; Opioid Use Disorder Treatment; Posttraumatic stress; Methadone treatment; Workforce Development; Vicarious trauma
• Other Study ID Numbers: 456482

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A Data Sharing and Management Plan was submitted to NIDA for this study. please see that submission.
• IPD Sharing Time Frame: 1 year after the study completion
• IPD Sharing Access Criteria: See Data sharing and management plan
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No