Facilitating the Implementation of Interim Methadone to Increase Treatment Access

NCT ID: NCT04188977

Last Updated: 2022-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2022-04-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Type 3 implementation-effectiveness type study using a modified stepped wedge design
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Caregivers
OTPs are masked during their Pre-Implementation Phase.

Study Groups

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Usual Practice

OTPs are able to request from state and federal health department officials to utilize interim methadone treatment to address admission delays in their OTP.

Group Type OTHER

Usual Practice

Intervention Type OTHER

OTP Directors are able to ask their state health officials permission to use interim methadone treatment. The state officials are in turn able to ask officials from the Center of Substance Abuse Treatment for permission to provide interim methadone treatment.

Implementation Facilitation

Implementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials.

Group Type EXPERIMENTAL

Implementation Facilitation

Intervention Type OTHER

Implementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials.

Interventions

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Usual Practice

OTP Directors are able to ask their state health officials permission to use interim methadone treatment. The state officials are in turn able to ask officials from the Center of Substance Abuse Treatment for permission to provide interim methadone treatment.

Intervention Type OTHER

Implementation Facilitation

Implementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* OTP staff
* State health department staff responsible for OTP oversight


* requesting admission to OTP

Exclusion Criteria

* Unwilling to be interviewed


* None
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

Friends Research Institute, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert P Schwartz, M.D.

Role: PRINCIPAL_INVESTIGATOR

Friends Research Institute, Inc.

Locations

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Robert Philip Schwartz, M.D.

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Gryczynski J, Mitchell SG, Whitter M, Fuller D, Mitchell MM, Edelman EJ, Schwartz RP. A trial of implementation facilitation to increase timely admission to methadone treatment. J Subst Use Addict Treat. 2024 Jul;162:209375. doi: 10.1016/j.josat.2024.209375. Epub 2024 Apr 19.

Reference Type DERIVED
PMID: 38642889 (View on PubMed)

Mitchell SG, Jester J, Gryczynski J, Whitter M, Fuller D, Halsted C, Schwartz RP. Impact of COVID-19-related methadone regulatory flexibilities: views of state opioid treatment authorities and program staff. Addict Sci Clin Pract. 2023 Oct 17;18(1):61. doi: 10.1186/s13722-023-00417-7.

Reference Type DERIVED
PMID: 37848970 (View on PubMed)

Other Identifiers

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U01DA046910

Identifier Type: NIH

Identifier Source: secondary_id

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U01DA046910

Identifier Type: NIH

Identifier Source: org_study_id

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