Improving Methadone Take-Home Dosing for Opioid Use Disorder
This study is testing a new approach to help opioid treatment programs (OTPs) offer more flexible take-home doses of methadone, a medication used to treat opioid use disorder (OUD). The goal is to see if a special program for clinics can improve how they make decisions about take-home doses, reduce confusion about rules, and address concerns about legal issues and money. This could help more people stay in treatment. Researchers will compare clinics using this program to those providing their usual care. The study will look at changes in how often 7-day, 14-day, and 28-day take-home methadone prescriptions are given. Adults aged 18 and older who are staff members at participating clinics can be part of this study. The current status of this study is unclear.
- Study design
- This study is an interventional trial planning to enroll 318 participants. It uses a stepped-wedge randomized controlled trial design, meaning clinics will gradually switch from usual care to the new intervention.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures changes in take-home prescriptions from before the intervention up to 30 months, and after the intervention from 6 months up to 36 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Leveraging Regulatory Flexibility for Methadone Take-Home Dosing to Improve Retention in Treatment for Opioid Use Disorder
At a glance
Conditions
Where it's being run
4 sites across 2 statesStudy leadership
- Charles Neighbors, PhD · PRINCIPAL_INVESTIGATOR · NYU Langone Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
What this trial measures
- Change from Baseline in 7-Day THD PrescriptionsPre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
7-day THD is defined as a prescription to pick up doses of methadone every 7 days or less often.
- Change from Baseline in 14-Day THD PrescriptionsPre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
14-day THD is defined as a prescription to pick up doses of methadone every 14 days or less often.
- Change from Baseline in 28-Day THD PrescriptionsPre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
28-day THD is defined as a prescription to pick up doses of methadone every 28 days or less often.
- Change from Baseline in OTP Care RetentionPre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
Will be calculated only among patients who have been in treatment for less than 12 months at the start of the study.
- Change from Baseline in Number of Emergency Department VisitsPre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
- Change from Baseline in Number of HospitalizationsPre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
- Change from Baseline in All-Cause MortalityPre-Intervention (from Baseline up to Month 30), Post-Intervention (from Month 6 up to Month 36)
All-Cause Mortality defined as death due to any cause.