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

Status: Recruiting

Location: See all (4) locations...

Intervention Type: Behavioral

Study Type: Interventional

Study Phase: Not Applicable

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

Participation Requirements

Sex: All

Minimum Age: 18

Healthy Volunteers: t

View:

• 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.

Locations

United States

Connecticut

University of Connecticut

RECRUITING

Storrs

New York

University at Buffalo

RECRUITING

Buffalo

NYU Langone Health

RECRUITING

New York

Weill Cornell Medical College

RECRUITING

New York

Contact Information

Primary

Charles Neighbors, PhD

Charles.Neighbors@nyulangone.org

646-501-3875

Backup

Beth Knopf, MPH

Elizabeth.Knopf@nyulangone.org

646-481-2528

Time Frame

Start Date: 2023-01-27

Estimated Completion Date: 2027-08-31

Participants

Target number of participants: 318

Treatments

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.

Related Therapeutic Areas

Opioid Use Disorder

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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

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