Reducing Overdose After Release From Incarceration

Overdose, Drug Clinical Trial

— ROAR  

Official title:

Reducing Overdose After Release From Incarceration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03902821
• Other study ID #: ROAR
• Status: Completed
• Start date: June 17, 2019
• Est. completion date: November 30, 2023

Study information

• Verified date: April 2024
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 30, 2023
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Drug Overdose
• Overdose, Drug

Intervention

Other:
• XR-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.

Locations

Country	Name	City	State
United States	Oregon Department of Corrections	Wilsonville	Oregon

Sponsors (6)

Lead Sponsor	Collaborator
Oregon Health and Science University	Bridgeway Recovery, CODA Inc., Health Insight, Oregon Department of Corrections, Oregon State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Any Opioid Overdose	This is a binary outcome indicating a fatal or non-fatal opioid-related overdose event	6 months after release from incarceration