Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder

Conditions

• Problems Related to Social Environment

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Clinic-Level Multidimensional Intervention — BEHAVIORAL
  The proximal goal of the intervention will be to increase OTP uptake of flexible THD. The intervention addresses facilitators and barriers to THD practices as identified by existing studies as well as those found during the first phase of the current project. The intervention will be designed to address the information gaps, training needs, and beliefs of individuals across the organizations.

Study Details

Using a stepped-wedge randomized controlled trial, the study will test whether a clinic-level multidimensional intervention conducted in 36 opioid treatment programs (OTPs) will improve clinical decision making, regulatory confusion, legal liability concerns, capacity for clinical practice change, and financial barriers to take- home dosing (THD) for methadone as compared to treatment as usual.

Key Dates

Start date

Jan 27, 2023

Status verified

Jan 2026

Primary completion

Aug 31, 2026

Completion

Aug 31, 2027

Study Design

Enrollment

318 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Cohort 1
  6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in group 1. Group 1 will start the six-month intervention at Baseline and end at Month 6.
• Experimental: Cohort 2
  6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 2. Cohort 2 will start the six-month intervention at Month 6 and end at Month 12.
• Experimental: Cohort 3
  6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 3. Cohort 3 will start the six-month intervention at Month 12 and end at Month 18.
• Experimental: Cohort 4
  6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 4. Cohort 4 will start the six-month intervention at Month 18 and end at Month 24.
• Experimental: Cohort 5
  6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 5. Cohort 5 will start the six-month intervention at Month 24 and end at Month 30.
• Experimental: Cohort 6
  6 of the 36 recruited opioid treatment programs (OTPs) will be enrolled in Cohort 5. Cohort 5 will start the six-month intervention at Month 30 and end at Month 36.

Primary Outcome Measure

Change from Baseline in 7-Day THD Prescriptions [ Time Frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36) ]

Central Contacts

• Charles Neighbors, PhD
  646-501-3875
  [email protected]
• Beth Knopf, MPH
  646-481-2528
  [email protected]

Locations (4)

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