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

NCT05675735 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 318

Last updated 2026-01-28

No results posted yet for this study

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.

Conditions

  • Problems Related to Social Environment

Interventions

BEHAVIORAL

Clinic-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.

Sponsors & Collaborators

Principal Investigators

  • Charles Neighbors, PhD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-01-27
Primary Completion
2026-08-31
Completion
2027-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05675735 on ClinicalTrials.gov