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Methadone Patient Access to Collaborative Treatment

Methadone Patient Access to Collaborative Treatment (MPACT)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06556602
Acronym
MPACT
Enrollment
1080
Registered
2024-08-16
Start date
2026-02-05
Completion date
2029-06-30
Last updated
2026-07-16

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

Conditions

Opioid Use Disorder, Patients, Staff

Keywords

Methadone

Brief summary

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.

Detailed description

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.

Interventions

OTHERMPACT

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

Sponsors

University of Arizona
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Hybrid Type 1, 20-month simultaneous cluster randomized controlled trial in 36 clinics

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Days in Treatment to treatment interruption18 monthsTime (days) to treatment interruption
Missed doses20 monthsMissed methadone doses in the last 30 days
In Treatment- Point in time18 monthsPoint in time in treatment (0 day, 30 day, 60, day, 90 day)
Number of patients reporting opioid overdoses while in methadone treatment18 monthsReported overdoses by patients in methadone treatment during the trial period by survey measured at 5 points during the study period.

Secondary

MeasureTime frameDescription
Number of staff experiencing vicarious (work related) stress18 monthsPost 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
Number of patients and staff experiencing post traumatic stress symptoms18 monthsPost 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 17, 2026