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Completed

NCT Number: NCT03902821

Reducing Overdose After Release From Incarceration

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.

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Key information

Age range

18 year–100 year

Sex eligibility

Female

Study type

Observational

Primary location

Oregon Department of Corrections

Wilsonville, Oregon, 97070, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

XR-NTX and Certified Recovery Mentor

Other

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.

Primary outcomes

  1. Any Opioid Overdose

    Time frame: 6 months after release from incarceration

    This is a binary outcome indicating a fatal or non-fatal opioid-related overdose event

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Collaborators

  • Bridgeway Recovery
  • CODA Inc.
  • Health Insight
  • Oregon Department of Corrections
  • Oregon State University

Registry information

Acronym: ROAR

Important dates

Study start
2019
Primary completion
2021
Study completion
2023
First posted
Apr 4, 2019
Registry last updated
Apr 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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