Reducing Overdose After Release From Incarceration (ROAR)

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.

Study Overview

• Status: Completed
• Conditions: Overdose, Drug
• Intervention / Treatment: Other: XR-NTX and Certified Recovery Mentor

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.

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Wilsonville, Oregon, United States, 97070
      • Oregon Department of Corrections

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will directly recruit incarcerated adult females who meet the DSM-V criteria for moderate or severe opioid use disorder. All participants will have a scheduled release date to Marion, Multnomah, Washington, or Clackamas County, Oregon.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Any Opioid Overdose	This is a binary outcome indicating a fatal or non-fatal opioid-related overdose event	6 months after release from incarceration

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Collaborators: Oregon State University; Oregon Department of Corrections; CODA Inc.; Bridgeway Recovery; Health Insight
• Investigators: Principal Investigator: Elizabeth Waddell, PhD, Oregon Health and Science University

Publications and helpful links

General Publications

• Waddell EN, Baker R, Hartung DM, Hildebran CJ, Nguyen T, Collins DM, Larsen JE, Stack E; ROAR Protocol Development Team. Reducing overdose after release from incarceration (ROAR): study protocol for an intervention to reduce risk of fatal and non-fatal opioid overdose among women after release from prison. Health Justice. 2020 Jul 10;8(1):18. doi: 10.1186/s40352-020-00113-7.

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2019
• Primary Completion (Actual): July 14, 2021
• Study Completion (Actual): November 30, 2023

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: April 2, 2019
• First Posted (Actual): April 4, 2019

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Prescription Drug Misuse; Drug Misuse; Drug Overdose
• Other Study ID Numbers: ROAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes