Methadone Patient Access to Collaborative Treatment

NCT ID: NCT06556602

Last Updated: 2024-08-19

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-04-30

Study Completion Date

2030-08-31

Brief Summary

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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

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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.

Conditions

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Opioid Use Disorder Staff Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Hybrid Type 1, 18-month simultaneous cluster randomized controlled trial in 30 clinics
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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MPACT Intervention

Enrolled clinic staff will be exposed to the MPACT intervention components over the trial period. This includes accredited training, clinic self assessment, reflective supervision for counseling/peer/case management staff, and wellness education with navigation to trauma symptoms assessment and resources including trauma treatment. Periodic surveys of staff and patients will be conducted to assess outcome measures (primary and secondary) and patient chart reviews will verify patient outcomes.

Group Type EXPERIMENTAL

MPACT

Intervention Type 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

Control for MPACT

Enrolled clinic staff will not receive any portion of the intervention. Periodic surveys of staff and patients will be conducted to assess outcome measures (primary and secondary) and patient chart reviews will verify patient outcomes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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MPACT

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

Intervention Type OTHER

Eligibility Criteria

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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
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

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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456483

Identifier Type: -

Identifier Source: org_study_id

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