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Completed

NCT Number: NCT06513728

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

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.

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Key information

Conditions

Opioid Substitution Treatment Clinics Behavior Behavioral Symptoms Chemically-Induced Disorders Compassion Fatigue Fatigue Mental Disorders Mental Fatigue Narcotic-Related Disorders Occupational Stress Opioid-Related Disorders Pathological Conditions, Signs and Symptoms Patients Signs and Symptoms Staff Stress, Psychological 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 Medicine

Tucson, Arizona, 85714, United States

About this study

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:

  • Determine MPACT implementation feasibility, acceptability, and preliminary effect on MMT practice change and culture.
  • Determine MPACT preliminary effect on MMT retention, in-MMT overdose, and patient PTSS.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

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.

Primary outcomes

  1. methadone treatment retention

    Time frame: 4 months (pilot study period)

    Retention in methadone treatment (measured by 3 different indicators)

  2. In treatment overdose

    Time frame: 4 months (pilot study period)

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

Secondary outcomes

  1. Trauma symptoms among patients and staff

    Time frame: pilot period of 4 months

    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.

  2. Vicarious Trauma symptoms among staff

    Time frame: pilot period of 4 months

    Vicarious trauma symptoms (measured by the Vicarious Trauma Scale (VTS). Scores are 0-190. Higher scores indicate more vicarious (work related) traumatization.

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

Methadone Patient Access to Collaborative Treatment

Acronym: MPACT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 22, 2024
Registry last updated
Aug 8, 2025

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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