RecruitingNot ApplicableNCT05675735

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

Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder: A Stepped-Wedge Randomized Trial to Facilitate Clinic Level Changes


Sponsor

NYU Langone Health

Enrollment

318 participants

Start Date

Jan 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria2

  • Clinic staff inclusion will include anyone who works at the 10 clinics that the OASAS client data system generates from the quantitative analysis in year one. In years 2-5, clinics chosen by the OASAS client data system will be placed into six cohorts. Only staff from these clinics will be eligible.
  • Patient inclusion will include anyone aged 18 or older who has been receiving take-home methadone for at least 30 days.

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Interventions

BEHAVIORALClinic-Level Multidimensional Intervention

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.


Locations(4)

University of Connecticut

Storrs, Connecticut, United States

University at Buffalo

Buffalo, New York, United States

NYU Langone Health

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

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NCT05675735