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NCT Number: NCT06556602

Methadone Patient Access to Collaborative Treatment

The trial of Methadone Patient Access to Collaborative Treatment (MPACT) will establish the impact of the intervention on patient outcomes of methadone treatment retention and in treatment overdose.

It will also establish the impact of patient and staff trauma symptoms and clinic practice change on MPACT intervention implementation.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Patients Staff Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arizona College of Nursing

Tucson, Arizona, 85714, United States

Location status: Recruiting

Location contact

Beth Meyerson, PhD

CONTACT

[email protected]

520-626-0275

Beth Meyerson, PhD

PRINCIPAL_INVESTIGATOR

About this study

This MPACT trial will involve finalizing the refined MPACT intervention (materials, training) and conducting a Hybrid Type 1, 15-month cluster randomized controlled trial in 30 clinics with 600 patients (20/clinic) and 480 staff (18/clinic) to assess MPACT effect on patient outcomes and examine the relationship between staff trauma outcomes and MPACT implementation. R33 Specific AIMS:

AIM 1: Quantify the effects of MPACT on methadone treatment (MMT) practice change and opioid treatment program (OTP) culture.

AIM 2: Determine the efficacy of MPACT on MMT retention, in-MMT overdose and patient and staff post traumatic stress symptoms (PTSS) outcomes.

AIM 3: Evaluate the effect of patient and staff trauma symptoms on primary outcomes and staff MPACT implementation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Staff providing methadone treatment services at the enrolled opioid treatment programs

Exclusion criteria

  • Patients receiving methadone treatment at the enrolled opioid treatment programs

Treatment and study plan

MPACT

Other

Four components are part of this intervention: 1) accredited training about patient centered, trauma-informed care and the standard of care under the current federal regulation (42CFRpart8), 2) education about trauma and trauma symptoms including vicarious (work related) trauma and navigation to symptoms screening and resources including treatment, 3) reflective supervision for counseling, case management and peer staff, and 4) clinic self assessment for trauma-informed and patient centered care

Primary outcomes

  1. Days in Treatment to treatment interruption

    Time frame: 18 months

    Time (days) to treatment interruption

  2. Missed doses

    Time frame: 20 months

    Missed methadone doses in the last 30 days

  3. In Treatment- Point in time

    Time frame: 18 months

    Point in time in treatment (0 day, 30 day, 60, day, 90 day)

  4. Number of patients reporting opioid overdoses while in methadone treatment

    Time frame: 18 months

    Reported overdoses by patients in methadone treatment during the trial period by survey measured at 5 points during the study period.

Secondary outcomes

  1. Number of staff experiencing vicarious (work related) stress

    Time frame: 18 months

    Post traumatic stress symptoms and vicarious (work related) trauma symptoms measured by the Vicarious Trauma Scale (VTS). Total scores can be grouped into three categories to represent low (8-28), moderate (29-42) and high (43-56) levels of vicarious trauma symptoms

  2. Number of patients and staff experiencing post traumatic stress symptoms

    Time frame: 18 months

    Post traumatic stress symptoms measured by the 8-item PCL-5 measuring post traumatic stress symptoms. Scores range from 0-80, with higher scores representing greater levels of traumatic stress symptomatology.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

Methadone Patient Access to Collaborative Treatment (MPACT)

Acronym: MPACT

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Aug 16, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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