Methadone patient access to collaborative treatment (MPACT): Protocol for a pilot and a randomized controlled trial to establish feasibility of adoption and impact on methadone treatment delivery and patient outcomes.

Abstract

Background: Access to methadone treatment can reduce opioid overdose death by up to 60%, but U.S. patient outcomes are suboptimal. Federally-allowed methadone treatment accommodations during the COVID public health emergency were not widely adopted. It is likely that staff-level characteristics such as trauma symptoms influence adoption of treatment innovation.

Objective: Methadone Patient Access to Collaborative Treatment (MPACT) is a two-phased project (pilot and field trial) to develop and test a staff-level, multimodal intervention to increase staff adoption of methadone treatment innovation and ultimately improve patient outcomes of treatment retention.

Methods: A pilot and national trial will measure implementation feasibility, acceptability and effects of the MPACT intervention on treatment practice change, clinic culture, patient retention, and patient Posttraumatic stress symptoms (PTSS). The pilot will be a single-arm 5.5-month pilot study of MPACT conducted in two Arizona methadone treatment clinics (rural and urban) among 100 patients and 22 staff. The national trial will be a 20-month cluster randomized trial conducted among 40 clinics, 800 patients (20 per clinic) and 520 staff (13 per clinic). Data will be gathered by staff and patient survey and patient chart review. The primary study outcome is increased patient methadone treatment retention measured as: 1) time to first treatment interruption from study enrollment, 2) active in treatment at enrollment, day 30, 60, 90, and 120, 3) continuous days in treatment during the study period. Secondary study outcomes include reductions in vicarious trauma (VT) and PTSS among enrolled opioid treatment program staff and PTSS among enrolled patients.

Results: This study is funded (currently) by the National Institute on Drug Abuse under Award Number R61DA059889, funded September 2023. As of November 30, 2025, we recruited all pilot participants and are in the second month of the pilot study. The pilot study will conclude in March of 2025 at which time we will initiate data analysis. The randomized controlled trial will begin in December 2025.

Conclusions: The MPACT study will provide a foundation for an evidence-based, staff-level intervention aimed at improving patient retention in methadone treatment. Future studies should examine the individual components of MPACT to determine their differential contributions to the primary outcome of patient methadone treatment retention, and to secondary outcomes of staff and patient reduction in stress symptoms.

Clinicaltrial: Clinicaltrials.gov NCT06513728, pilot and NCT06556602 for trial.