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

NYU Langone Health · with National Institutes of Health (NIH) · NCT05675735

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
318
US sites recruiting
4
Study start
January 27, 2023
Record last updated
August 12, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Clinic-Level Multidimensional Intervention

Conditions: Problems Related to Social Environment

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • There are no exclusion criteria related to sex/gender to increase the generalizability of the findings. The investigators will note include children in this study because the treatment system that we are examining largely excludes adolescents and younger children.

Recruiting US locations

  • University of Connecticut

    Storrs, CT 06268

    Site contact: Megan O'Grady, Ph.D.

  • University at Buffalo

    Buffalo, NY 14260

  • NYU Langone Health

    New York, NY 10016

    Site contact: Charles Neighbors, PhD

  • Weill Cornell Medical College

    New York, NY 10065

    Site contact: Yuhua Bao

Study contacts (from the official record)

  • Charles Neighbors, PhD · 646-501-3875 · Charles.Neighbors@nyulangone.org
  • Beth Knopf, MPH · 646-481-2528 · Elizabeth.Knopf@nyulangone.org
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Leveraging Regulatory Flexibility for Methadone Take-Home Dosing… (NCT05675735) | Bored Studies