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Reducing Overdose After Release From Incarceration

Reducing Overdose After Release From Incarceration

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03902821
Acronym
ROAR
Enrollment
65
Registered
2019-04-04
Start date
2019-06-17
Completion date
2023-11-30
Last updated
2024-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overdose, Drug

Brief summary

The primary objective of the ROAR project is to evaluate an Oregon Department of Corrections (ODOC) pilot program that combines the use of extended-release naltrexone (XR-NTX) and Certified Recovery Mentors pre-release with linkage to community substance use disorder treatment to prevent fatal and non-fatal opioid overdoses among female adults released from prison.

Detailed description

ROAR examines implementation of a novel overdose prevention strategy for justice-involved women as they re-enter community treatment settings after incarceration. The ODOC pilot project offers initiation of opioid antagonist treatment prior to release (extended-release naltrexone \[XR-NTX\]), ongoing support from a Certified Recovery Mentor (CRM), and facilitated entry into community treatment for substance use disorders. Community treatment may include continuation of XR-NTX,or transition to agonist therapy including buprenorphine or methadone, or no medication for opioid use disorder.

Interventions

OTHERXR-NTX and Certified Recovery Mentor

All consented participants will be offered an injection of extended-release naltrexone 3-7 days prior to release from prison. All consented participants will also be introduced to Certified Recovery Mentors one month prior to release.

Sponsors

Oregon Department of Corrections
CollaboratorUNKNOWN
CODA Inc.
CollaboratorUNKNOWN
Bridgeway Recovery
CollaboratorUNKNOWN
Health Insight
CollaboratorUNKNOWN
Oregon State University
CollaboratorOTHER
Oregon Health and Science University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* Be a woman (including transgender and non-binary adults assigned to women's housing at CCCF) * 18 years of age or older with a known release date during the 18-month recruitment period * Be released to Marion, Multnomah, Clackamas or Washington County, Oregon * Be willing and able to provide informed consent and HIPAA authorization for medical record abstraction and linkage to state administrative data * Meet DSM-V (Diagnostic and Statistical Manual) criteria for moderate or severe opioid use disorder * Be willing to establish ongoing care at the community SUD (substance use disorder) treatment site in county of release * Be willing to initiate XR-NTX prior to release from incarceration * Not be currently pregnant and must be willing to take at least one evidence-based measure to avoid becoming pregnant during treatment with XR-NTX

Exclusion criteria

A participant will be excluded if she * Has a severe medical, psychiatric, or substance use disorder that, in the opinion of the CCCF Qualified Mental Health Professional (QMHP)or study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study due to imminent risk of death * Has another medical condition leading XR-NTX to be contraindicated * Has chronic pain requiring ongoing pain management with opioid analgesics * Received methadone or buprenorphine maintenance therapy in the 4 weeks prior to consent * Has a planned surgery or other procedure within the next 4 weeks that will require opioid analgesia

Design outcomes

Primary

MeasureTime frameDescription
Any Opioid Overdose6 months after release from incarcerationThis is a binary outcome indicating a fatal or non-fatal opioid-related overdose event

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026