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Reducing Overdose After Release From Incarceration (ROAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03902821
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : August 12, 2020
Sponsor:
Collaborators:
Oregon Department of Corrections
CODA Inc.
Bridgeway Recovery
Health Insight
Oregon State University
Information provided by (Responsible Party):
Elizabeth Waddell, Oregon Health and Science University

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.

Condition or disease Intervention/treatment
Overdose, Drug 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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Reducing Overdose After Release From Incarceration
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : November 1, 2021
Estimated Study Completion Date : November 1, 2021

Intervention Details:
  • 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.


Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Study sample is composed of women including transgender and non-binary adults assigned to women's housing at Coffee Creek Correctional Facility.
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.
Criteria

Inclusion Criteria:

  • Be a woman (including transgenderand 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 criteria for moderate or severe opioid use disorder
  • Be willing to establish ongoing care at the community SUD 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 CCCFQualified 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03902821


Contacts
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Contact: Elizabeth Waddell, PhD 503-494-3732 waddelle@ohsu.edu
Contact: Ceilidh Nichols, BS 503-494-3365 nicholce@ohsu.edu

Locations
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United States, Oregon
Oregon Department of Corrections Recruiting
Wilsonville, Oregon, United States, 97070
Contact: Dawnell Meyer    503-378-6886      
Sponsors and Collaborators
Oregon Health and Science University
Oregon Department of Corrections
CODA Inc.
Bridgeway Recovery
Health Insight
Oregon State University
Investigators
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Principal Investigator: Elizabeth Waddell, PhD Oregon Health and Science University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Elizabeth Waddell, Assistant Professor and Program Director, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT03902821    
Other Study ID Numbers: ROAR
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders