Methadone Patient Access to Collaborative Treatment

NCT06556602 | Not Yet Recruiting DMC

• 1 other identifier: 456483
• Study Type: interventional
• Target: 1,080
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder; Staff; Patients

Keywords

Methadone

Outcome Measures

Primary Outcomes (4)

• Days in Treatment to treatment interruption

  Time (days) to treatment interruption

  18 months

• Time to treatment cessation

  Time to treatment cessation (tolerance of 30 days)

  18 months

• In Treatment- Point in time

  Point in time in treatment (0 day, 30 day, 60, day, 90 day)

  18 months

• Number of patients reporting opioid overdoses while in methadone treatment

  Reported overdoses by patients in methadone treatment during the trial period by survey measured at 5 points during the study period.

  18 months

Secondary Outcomes (2)

• Number of staff experiencing vicarious (work related) stress

  18 months

• Number of patients and staff experiencing post traumatic stress symptoms

  18 months

Study Arms (2)

MPACT Intervention

EXPERIMENTAL

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.

Other: MPACT

Control for MPACT

NO INTERVENTION

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.

Interventions

MPACT 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

MPACT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Staff providing methadone treatment services at the enrolled opioid treatment programs

You may not qualify if:

• Patients receiving methadone treatment at the enrolled opioid treatment programs

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

University of Arizona College of Medicine

Tucson, Arizona, 85714, United States

Location

Related Publications (1)

• 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.

  PMID: 40105313 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Hybrid Type 1, 18-month simultaneous cluster randomized controlled trial in 30 clinics

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: August 16, 2024
• Study Start: April 1, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): August 1, 2030
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Within 2 years of study completion
• Access Criteria: See Data Management and Sharing Plan

Locations

US (1)