NCT04308694

Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment

A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone Through Community Pharmacies for Their Stable Methadone Patients

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Friends Research Institute, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The overarching goal of this pilot study is to explore the feasibility, acceptability, and patient/provider satisfaction of pharmacy-based administration and dispensing of methadone for opioid use disorder. The results gained will inform the development of a future multisite randomized clinical trial.

Detailed description

The study will use a non-randomized, prospective, single group design. Twenty long-term, clinically-stable methadone maintenance treatment (MMT) patients who receive between 6- and 13-days methadone take-home doses will be enrolled in the study where their methadone take-home administration and dispensing will be transferred to a community pharmacy for 3 months. Participants will also complete three follow-up assessments at 1-month, 2-months, and 3-months after the baseline visit to collect clinical and safety information since the previous assessment. Primary outcomes will be focused on feasibility measures (recruitment, accessibility to methadone treatment, substance use, medication call back success, and retention in treatment). Secondary outcomes will be focused on self-reported satisfaction measures from MMT providers (e.g., physician, physician assistant, nurse, and counselor) pharmacists, and patient participants.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Pharmacy-based methadone administration and dispensing	Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.

Timeline

• Start date: 2020-08-06
• Primary completion: 2021-01-05
• Completion: 2021-01-18
• First posted: 2020-03-16
• Last updated: 2022-04-01
• Results posted: 2021-12-02

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study