Pilot Study of Methadone Patient Access to Collaborative Treatment

Not Applicable

Recruiting

• Conditions: Opioid Substitution Treatment Clinics; Patients; Staff

• Registration Number: NCT06513728
• Lead Sponsor: University of Arizona

Brief Summary

Examine the preliminary effect of the MPACT intervention on methadone treatment retention, in treatment overdose and patient trauma symptoms. The study will also explore the relationship between staff trauma symptoms and MPACT implementation.

Detailed Description

Specific AIMS:

AIM 1: Develop MPACT through multilevel, iterative planning with OTP staff and people with recent MMT experience.

AIM 2: Conduct a 4-month MPACT pilot test in two AZ OTPs: Mesa (urban) with 50 patients and 22 staff, and Sierra Vista (rural-serving) with 50 patients and 8 staff to:

1. Determine MPACT implementation feasibility, acceptability, and preliminary effect on MMT practice change and culture.

2. Determine MPACT preliminary effect on MMT retention, in-MMT overdose, and patient PTSS.

3. Characterize staff trauma history, PTSS and vicarious trauma, and explore their relationship with MPACT acceptability and implementation fidelity.

AIM 3: Characterize MPACT acceptability, likely adoption, and recruitment feasibility among directors, case managers and counselors from a national random sample of 500 OTPs.

Study Timeline

• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Study First Posted: 2024-07-22
• Study Start: 2024-09-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-27
• Primary Completion: 2025-03-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Staff of enrolled opioid treatment programs (methadone clinics) who are involved with methadone treatment
• Patients receiving methadone at these locations

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Exclusion Criteria

• Patients not receiving methadone at these locations
• Staff not involved in methadone treatment at these locations

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
methadone treatment retention	4 months (pilot study period)	Retention in methadone treatment (measured by 3 different indicators)
In treatment overdose	4 months (pilot study period)	Reported overdoses during methadone treatment (measured by study constructed algorithm)

Secondary Outcome Measures

Name	Time	Method
Vicarious Trauma symptoms among staff	pilot period of 4 months	Vicarious trauma symptoms (measured by the Vicarious Trauma Scale (VTS). Scores are 0-190. Higher scores indicate more vicarious (work related) traumatization.
Trauma symptoms among patients and staff	pilot period of 4 months	Post traumatic stress symptoms (measured by 8-item Post Traumatic Stress Disorder Checklist or, PCL-5). Scores are 0-80. Higher scores mean greater PTSD symptom severity.

Trial Locations

Locations (1)

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