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

Methadone Patient Access to Collaborative Treatment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06513728
Acronym
MPACT
Enrollment
102
Registered
2024-07-22
Start date
2024-09-26
Completion date
2025-04-30
Last updated
2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

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.

Interventions

OTHERMPACT 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.

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
methadone treatment retention4 months (pilot study period)Retention in methadone treatment (measured by 3 different indicators)
In treatment overdose4 months (pilot study period)Reported overdoses during methadone treatment (measured by study constructed algorithm)

Secondary

MeasureTime frameDescription
Trauma symptoms among patients and staffpilot period of 4 monthsPost 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.
Vicarious Trauma symptoms among staffpilot period of 4 monthsVicarious trauma symptoms (measured by the Vicarious Trauma Scale (VTS). Scores are 0-190. Higher scores indicate more vicarious (work related) traumatization.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026