Overdose, DrugROARNCT03902821
Reducing Overdose After Release From Incarceration
An observational study of Overdose, Drug, run by Oregon Health and Science University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Overdose, Drug
- What is being tested?
- XR-NTX and Certified Recovery Mentor
- Type of treatment
- Injection or infusion
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2019to 30 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Department of Corrections
Wilsonville, Oregon, 97070
About this study
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.
Read the 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.
- Conditions
- Overdose, Drug
- Being tested
- XR-NTX and Certified Recovery Mentor
- Medical subject headings
- Drug Overdose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XR-NTX and Certified Recovery MentorOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Any Opioid Overdose
This is a binary outcome indicating a fatal or non-fatal opioid-related overdose event
Measured: 6 months after release from incarceration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2019
- Study start17 Jun 2019
- Primary completion14 Jul 2021
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overdose, DrugStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- Oregon Department of Corrections, CODA Inc., Bridgeway Recovery, Health Insight, Oregon State University
- Responsible party
- Principal investigator, Elizabeth Waddell, Oregon Health and Science University
- Investigators
- Elizabeth Waddell, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902821
- Sponsor's protocol ID
- ROAR
- Acronym
- ROAR
- Status last verified
- Apr 2024
- First submitted
- 21 Mar 2019
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32651887
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Overdose After Release From Incarceration
- ClinicalTrials.gov ID
- NCT03902821
- Acronym / sponsor ID
- ROAR / ROAR
- Conditions
- Overdose, Drug
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- Oregon Department of Corrections, CODA Inc., Bridgeway Recovery, Health Insight, Oregon State University
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 14 Jul 2021 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 4 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XR-NTX and Certified Recovery MentorAll 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. | Other | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
- Derived from this study: PubMed 32651887Waddell 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth Waddell, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overdose, Drug, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Any Opioid Overdose (time frame: 6 months after release from incarceration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03902821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2024.