Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 11:17 PM
Study NCT ID:
NCT04308694
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2020-03-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Opioid Treatment Program (OTP)-Pharmacy Collaboration for Methadone Maintenance Treatment
Sponsor:
Friends Research Institute, Inc.
Organization:
Study Overview
Official Title:
A Pilot Study to Permit Opioid Treatment Program Physicians to Prescribe Methadone Through Community Pharmacies for Their Stable Methadone Patients
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 3U01DA046910-02S3 | NIH | None | https://reporter.nih.gov/quic… | View |