Clinical trial NCT03902821: Reducing Overdose After Release From Incarceration
Official title: Reducing Overdose After Release From Incarceration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overdose, Drug
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Oregon Department of Corrections
name: CODA Inc.
name: Bridgeway Recovery
name: Health Insight
name: Oregon State University
First posted: 2019-04-04
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Any Opioid Overdose
timeFrame: 6 months after release from incarceration
Secondary outcomes:
Other outcomes:
Locations:
city: Wilsonville
country: United States
facility: Oregon Department of Corrections
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Elizabeth Waddell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.