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Clinical Trials/NCT04188977
NCT04188977
Completed
Not Applicable

Facilitating the Implementation of Interim Methadone to Increase Treatment Access: A Multi-Site Implementation Trial

Friends Research Institute, Inc.1 site in 1 country18 target enrollmentNovember 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Opioid-use Disorder
Sponsor
Friends Research Institute, Inc.
Enrollment
18
Locations
1
Primary Endpoint
Accessibility
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

The primary aim of this study is to evaluate the effectiveness of Implementation Facilitation (IF) in promoting increased accessibility to methadone treatment.

Detailed Description

This is a Type 3 implementation-effectiveness type study using a modified stepped wedge design. The study's purpose is to examine the effectiveness of Implementation Facilitation (IF) to prompt participating Opioid Treatment Programs (OTPs) to utilize interim methadone treatment and other approaches to reduce OTP admission delays. Interim methadone treamtent is an evidence-based practice permitted under federal OTP regulations to provide methadone treatment without routine counseling for individuals requesting methadone treatment who otherwise would not be able to be admitted to such treatment within 14 days of request. The study will be conducted at six OTPs in the US that are unable to admit individuals within 14 days of their request for methadone treatment. The OTPs will participate in a baseline Pre-Implementation Phase, an Implementation Phase, followed by a Sustainability Phase. OTPs will be randomly assigned in groups of two to the order in which they will initiate the Implementation Phase. IF will be delivered at the level of the OTP staff and their state health department official responsible for OTP oversight. OTP staff and state health department officials will be interviewed regarding facilitators and barriers to implementing interim methadone and other approaches to reduce admission delays. De-identified data will be gathered from the OTPs on the effectiveness of IF in prompting the implementation of interim methadone and reducing admission delays.

Registry
clinicaltrials.gov
Start Date
November 1, 2019
End Date
April 30, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Unwilling to be interviewed
  • Inclusion Criteria (OTP applicants):
  • requesting admission to OTP
  • Exclusion Criteria:

Outcomes

Primary Outcomes

Accessibility

Time Frame: Nine months

Accessibility will be assessed from de-identified OTP records as the proportion of individuals requesting methadone treatment who receive at least one dose of methadone through either interim methadone (IM) or standard methadone within 14 days, divided by the number of individuals requesting methadone treatment.

Secondary Outcomes

  • Uptake(Nine months)
  • Fidelity(Six months)
  • Uptake during the Sustainability Phase(Six months)
  • Effectiveness: percentage of opioid positive tests(Six months)
  • Efficiency(Nine months)

Study Sites (1)

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