Recruiting

Methadone

Sponsor:

NYU Langone Health

Code:

NCT05675735

Conditions

Problems Related to Social Environment

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Clinic-Level Multidimensional Intervention

Study Details

Brief 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

Study ID

NCT05675735

Start date

Jan 27, 2023

Status verified date

Aug, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Sep 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

318 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

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) ]
  • Change from Baseline in 14-Day THD Prescriptions [ Time Frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36) ]
  • Change from Baseline in 28-Day THD Prescriptions [ Time Frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36) ]
  • Change from Baseline in OTP Care Retention [ Time Frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36) ]
  • Change from Baseline in Number of Emergency Department Visits [ Time Frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36) ]
  • Change from Baseline in Number of Hospitalizations [ Time Frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36) ]
  • Change from Baseline in All-Cause Mortality [ Time Frame: Pre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36) ]

Central Contacts and Locations

Central contacts

Charles Neighbors, PhD

646-501-3875Charles.Neighbors@nyulangone.org

Beth Knopf, MPH

646-481-2528Elizabeth.Knopf@nyulangone.org

Locations

University of Connecticut

Recruiting

Storrs, Connecticut, United States, 06268

Principal Investigator:

Megan O'Grady, Ph.D.

University at Buffalo

Recruiting

Buffalo, New York, United States, 14260

NYU Langone Health

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Charles Neighbors, PhD

Weill Cornell Medical College

Recruiting

New York, New York, United States, 10065

Principal Investigator:

Yuhua Bao

More Information

Sponsor

NYU Langone Health

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-08-12.