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

NCT ID: NCT06513728

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-09-26

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Opioid Substitution Treatment Clinics Patients Staff

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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MPACT Intervention

Single arm study. All sites will receive the intervention.

Group Type EXPERIMENTAL

MPACT Intervention

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Beth Meyerson, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor

Locations

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University of Arizona College of Medicine

Tucson, Arizona, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 40105313 (View on PubMed)

Other Identifiers

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456482

Identifier Type: -

Identifier Source: org_study_id

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