Reducing Overdose After Release From Incarceration

NCT03902821 | Completed DMC FDA Drug

• 1 other identifier: ROAR
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Overdose, Drug

Outcome Measures

Primary Outcomes (1)

• Any Opioid Overdose

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

  6 months after release from incarceration

Interventions

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.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Gender Eligibility Details: Study sample is composed of women including transgender and non-binary adults assigned to women's housing at Coffee Creek Correctional Facility.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Be a woman (including transgender and non-binary adults assigned to women's housing at CCCF)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Oregon Department of Corrections: collaborator
• CODA Inc.: collaborator
• Bridgeway Recovery: collaborator
• Health Insight: collaborator
• Oregon State University: collaborator

Study Sites (1)

Oregon Department of Corrections

Wilsonville, Oregon, 97070, United States

Location

Related Publications (1)

• 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.

  PMID: 32651887 DERIVED

MeSH Terms

Conditions

Drug Overdose

Condition Hierarchy (Ancestors)

Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Elizabeth Waddell, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Program Director

Study Record Dates

• First Submitted: March 21, 2019
• First Posted: April 4, 2019
• Study Start: June 17, 2019
• Primary Completion: July 14, 2021
• Study Completion: November 30, 2023
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)