Methadone Patient Access to Collaborative Treatment

Not Applicable

Not yet recruiting

• Conditions: Opioid Use Disorder; Staff; Patients
• Interventions: Other: MPACT

• Registration Number: NCT06556602
• Lead Sponsor: University of Arizona

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.

Study Timeline

• Study First Submitted: 2024-07-16
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-15
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-19
• Study Start: 2026-04
• Primary Completion: 2029-11
• Study Completion: 2030-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1080

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MPACT Intervention	MPACT	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.

Primary Outcome Measures

Name	Time	Method
Time to treatment cessation	18 months	Time to treatment cessation (tolerance of 30 days)
In Treatment- Point in time	18 months	Point in time in treatment (0 day, 30 day, 60, day, 90 day)
Days in Treatment to treatment interruption	18 months	Time (days) to treatment interruption
Number of patients reporting opioid overdoses while in methadone treatment	18 months	Reported overdoses by patients in methadone treatment during the trial period by survey measured at 5 points during the study period.

Secondary Outcome Measures

Name	Time	Method
Number of staff experiencing vicarious (work related) stress	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
Number of patients and staff experiencing post traumatic stress symptoms	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.

Trial Locations

Locations (1)

University of Arizona College of Medicine; 🇺🇸 Tucson, Arizona, United States