Methadone Expansion in Detention Though the Hospital/Clinic Designation

NCT07707934 | Not Yet Recruiting

• 2 other identifiers: STUDY00000987R01DA064510
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to improve implementation of hospital/clinic methadone in several carceral systems and study the effects of implementation on patient outcomes. This study has four Aims:

• Evaluate an intervention for carceral staff that will receive individual coaching and group didactic sessions focused on improving adoption and implementation of hospital/clinic methadone. Effects of this intervention will be measured via qualitative interviews and baseline, midpoint and final surveys of participants.
• Apply a trial emulation approach to electronic health records from three prison systems currently using hospital/clinic methadone to evaluate the effect of implementation on the initiation and retention of medications for opioid use disorder treatment.
• Link Medicaid data to electronic health records from one prison system implementing hospital/clinic methadone to examine the effect of implementation on post-release outcomes, including MOUD use and broader healthcare utilization.
• Examine the cost effectiveness and budgetary impact of implementing hospital/clinic methadone.

Conditions

Opioid Use Disorder; Incarcerated Individuals; Methadone Maintenance

Outcome Measures

Primary Outcomes (1)

• Patients on methadone through h/c

  Number of patients receiving methadone via the hospital/clinic designation

  At baseline, at month 12, and at month 24

Secondary Outcomes (3)

• Implementation outcomes assessment

  At baseline, at month 12, and at month 24

• Staff Attitudes Towards MOUD

  At baseline, at month 12, and at month 24

• Organizational Readiness for Implementing Change

  At baseline, at month 12, and at month 24

Study Arms (1)

Learning Collaborative

OTHER

All participants will receive individual and group coaching sessions

Other: Learning Collaborative

Interventions

Learning Collaborative OTHER

All participants will receive individual and group coaching sessions to facilitate implementation of the hospital/clinic designation.

Learning Collaborative

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Employee of a carceral system interested in or implementing the hospital/clinic designation
• Involved in security, medical, or budget/administrative aspects of the carceral system

Sponsors & Collaborators

• Brendan Saloner: lead
• National Institute on Drug Abuse (NIDA): collaborator
• Johns Hopkins Bloomberg School of Public Health: collaborator
• Washington University School of Medicine: collaborator
• Brown University: collaborator

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Central Study Contacts

Brendan Saloner, PhD

CONTACT

401-863-2228; brendan_saloner@brown.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Donald G. Millar Distinguished Professor of Alcohol and Addiction Studies

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: July 16, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): May 31, 2030
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE