Opioid Use DisorderNCT06768814
Overdose Recovery and Care Access (ORCA) Qualitative Stakeholder Interviews and County-level Data
A study testing Sub-acute stabilization in people with Opioid Use Disorder and Opioid Use, run by University of Washington at 1 site in United States.
Trial summary
The study is a quasi-experimental investigation of a sub-acute stabilization center (SASC) for people who have had or are at risk for having an opioid overdose and have an encounter with Seattle Fire Department emergency medical services (EMS) in Seattle, WA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder, Opioid Use
- What is being tested?
- Sub-acute stabilization
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2024to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Verbally consents to transfer of care to SASC.
- Awake and oriented to person and place, with no significant deficits in mental status or neurological function.
- Age >=18
- Patent airway and effective respirations with adequate oxygenation.
- Stable heart rate and blood pressure, with no evidence of cardiac arrhythmias or other significant cardiovascular disfunction.
- Vitals:
Show all 25Show fewer
- Heart rate: 45-130
- Blood pressure: systolic 95-190, diastolic 50-120
- Respiratory rate: 10-24
- SpO2: >92 on room air or supplemental O2 via nasal cannula.
- SpO2 <92% with supplemental O2 requires ED transfer.
- EtCO2: <50
- Temperature: 95.5-100.3 F
- Blood glucose (if indicated): 60-300
- No signs of head trauma:
- Dizziness or loss of balance
- Blurred vision or double vision
- Sensitivity to light or noise
- Seizures or convulsions
- Weakness or numbness in the arms or legs
- Persistent or worsening headache
- CSF or blood leaking from the nose or ears
- Unequal pupils or pupils that are slow to react to light.
- No signs of other traumatic injury or medical needs requiring immediate treatment.
- No signs of respiratory infection. Screen for COVID-19. See COVID-19 Screening protocol.
Who cannot join
- People under 18 and who do not meet SASC admission criteria will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Downtown Emergency Service Center's Overdose Recovery and Care Access Centers
Seattle, Washington, 98104
Daniel Malone
About this study
The study is a quasi-experimental investigation of a sub-acute stabilization center (SASC) for people who have had or are at risk for having an opioid overdose and have an encounter with Seattle Fire Department emergency medical services (EMS) in Seattle, WA. Those transported to the SASC are the intervention participants and two comparison groups will be utilized: eligible Seattle EMS patients who opt not to go to the SASC and King County residents, outside of Seattle, who meet the same eligibility criteria. A comparative interrupted time series analysis is planned to study the main effectiveness outcomes.
Seattle Fire EMS will assess, refer, and arrange transport for participants to the SASC. The SASC will offer an array of services including post-overdose monitoring, utilization of buprenorphine and methadone for the treatment opioid use disorder and opioid withdrawal, linkage to ongoing care for OUD, and provision of harm reduction services and supplies. The length of stay in the SASC will be limited to less than 24 hours. A continuous process improvement (CPI) approach will monitor and refine the intervention. Characterization of the interventions will be based upon analysis of service utilization patterns over time along with interviews and surveys with stakeholders.
Read the detailed description
- Clinical Intervention
- We will be conducting a quasi-experimental study of a new sub-acute stabilization center (SASC) for those at high risk or who have had an opioid overdose to which Seattle Fire/EMS refer. All eligible people at risk or post OD who encounter Seattle Fire/EMS will potentially be offered the intervention, and those interested and transported will be considered study participants, there is no study assignment (anticipated n=5,495).
- Comparison groups will be identified from secondary EMS records data for Seattle (anticipated n=7,223) and the remainder of King County, WA (anticipated n=11,550).
- People 18 and older who EMS encounter who have had or are at high risk for any opioid overdose and meet clinical inclusion criteria.
- SASC services will be provided by Downtown Emergency Service Center's Overdose Recovery and Care Access Centers:
- 515 Third Avenue, Seattle, WA 98104
- 517 Third Avenue, Seattle, WA 98104
- 1600 South Lane Street Seattle, WA 98144
- Implementation research interviews with professional stakeholders
- We will be conducting repeated cross-sectional interviews with professional stakeholders about the implementation of the SASC and CPI activities.
- Participants will be 18 or older and include people such as: CPI meeting attendees, EMS personnel, and SASC staff (n=60).
- It is anticipated that stakeholder interviews will be conducted virtually via video conferencing with study team members.
- Implementation research surveys with people with lived experience of drug use
- We will be utilizing a combination of data sources. Initially in-person interview data from the 1R01DA059011-01 study (Van Draanen, PI) will be utilized for analyses.
- Participants from the Van Draanen study will be 18 or older who have have survived a non-fatal opioid overdose and had an emergency medical service interaction or intervention (n=80).
- If needed, we will also, subsequently conduct repeated cross-sectional surveys with people with lived experience of drug use about their experiences and perceptions of the SASC. Final procedures will be determined in collaboration with our community partner the Lived Expertise Advisory Board.
- Conditions
- Opioid Use Disorder, Opioid Use
- Being tested
- Sub-acute stabilization
- Keywords
- opioid overdose, opioid poisoning, harm-reduction, sub-acute stabilization
- Medical subject headings
- Opioid-Related Disorders, Opiate Overdose, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sub-acute stabilizationBehavioural
The sub-acute stabilization center (SASC) is for people who have had or are at risk for having an opioid overdose and have an encounter with Seattle Fire Department emergency medical services (EMS) in Seattle, WA. Those transported to the SASC are the intervention participants and two comparison groups will be utilized: eligible Seattle EMS patients who opt not to go to the SASC and King County residents, outside of Seattle, who meet the same eligibility criteria. A comparative interrupted time series analysis is planned to study the main effectiveness outcomes. Seattle Fire EMS will assess, refer, and arrange transport participants to the SASC. The SASC will offer an array of services including post-overdose monitoring, utilization of buprenorphine and methadone for the treatment opioid use disorder and opioid withdrawal, linkage to ongoing care for OUD, and provision of harm reduction services and supplies. The length of stay in the SASC will be limited to less than 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | The sub-acute stabilization center will combine: 1) post-overdose medical and social support, 2) the offer of starting medications for opioid use disorder, and 3) harm reduction services and supplies. Receives: Behavioral: Sub-acute stabilization |
| Comparison | No intervention | Eligible Seattle EMS patients who opt not to go to the sub-acute stabilization center, and King County residents, outside of Seattle, who meet the same eligibility criteria. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repeat opioid overdose
One of more opioid overdoses after enrollment
Measured: 1 year
MOUD initiation
Starting opioid use disorder treatment with buprenorphine, methadone or naltrexone
Measured: 1 year
MOUD retention
Having one or more additional doses prescribed, administered or dispensed of buprenorphine, methadone, or naltrexone
Measured: 1 year
Emergency department utilization
Having one or more all-cause emergency department admission
Measured: 1 year
EMS utilization
Having one or more emergency medical service encounters
Measured: 1 year
Cost-effectiveness
Analysis from the perspective of a public sector payer of the per unit cost of reduced opioid overdoses attributable to the diversion program
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2025
- Study start15 Dec 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Caleb Banta-Green, University of Washington
- Investigators
- Caleb Banta-Green, PhD, MPH, MSW, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06768814
- Sponsor's protocol ID
- STUDY00019871
- Other IDs
- R33DA057600
- Status last verified
- May 2026
- First submitted
- 6 Jan 2025
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overdose Recovery and Care Access (ORCA) Qualitative Stakeholder Interviews and County-level Data
- ClinicalTrials.gov ID
- NCT06768814
- Acronym / sponsor ID
- STUDY00019871
- Conditions
- Opioid Use Disorder, Opioid Use
- Keywords
- opioid overdose, opioid poisoning, harm-reduction, sub-acute stabilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40,000 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 10 Jan 2025 (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 study is a quasi-experimental investigation of a sub-acute stabilization center (SASC) for people who have had or are at risk for having an opioid overdose and have an encounter with Seattle Fire Department emergency medical services (EMS) in Seattle, WA. Those transported to the SASC are the intervention participants and two comparison groups will be utilized: eligible Seattle EMS patients who opt not to go to the SASC and King County residents, outside of Seattle, who meet the same eligibility criteria. A comparative interrupted time series analysis is planned to study the main effectiveness outcomes.
Seattle Fire EMS will assess, refer, and arrange transport for participants to the SASC. The SASC will offer an array of services including post-overdose monitoring, utilization of buprenorphine and methadone for the treatment opioid use disorder and opioid withdrawal, linkage to ongoing care for OUD, and provision of harm reduction services and supplies. The length of stay in the SASC will be limited to less than 24 hours. A continuous process improvement (CPI) approach will monitor and refine the intervention. Characterization of the interventions will be based upon analysis of service utilization patterns over time along with interviews and surveys with stakeholders.
Detailed description
- Clinical Intervention
- We will be conducting a quasi-experimental study of a new sub-acute stabilization center (SASC) for those at high risk or who have had an opioid overdose to which Seattle Fire/EMS refer. All eligible people at risk or post OD who encounter Seattle Fire/EMS will potentially be offered the intervention, and those interested and transported will be considered study participants, there is no study assignment (anticipated n=5,495).
- Comparison groups will be identified from secondary EMS records data for Seattle (anticipated n=7,223) and the remainder of King County, WA (anticipated n=11,550).
- People 18 and older who EMS encounter who have had or are at high risk for any opioid overdose and meet clinical inclusion criteria.
- SASC services will be provided by Downtown Emergency Service Center's Overdose Recovery and Care Access Centers:
- 515 Third Avenue, Seattle, WA 98104
- 517 Third Avenue, Seattle, WA 98104
- 1600 South Lane Street Seattle, WA 98144
- Implementation research interviews with professional stakeholders
- We will be conducting repeated cross-sectional interviews with professional stakeholders about the implementation of the SASC and CPI activities.
- Participants will be 18 or older and include people such as: CPI meeting attendees, EMS personnel, and SASC staff (n=60).
- It is anticipated that stakeholder interviews will be conducted virtually via video conferencing with study team members.
- Implementation research surveys with people with lived experience of drug use
- We will be utilizing a combination of data sources. Initially in-person interview data from the 1R01DA059011-01 study (Van Draanen, PI) will be utilized for analyses.
- Participants from the Van Draanen study will be 18 or older who have have survived a non-fatal opioid overdose and had an emergency medical service interaction or intervention (n=80).
- If needed, we will also, subsequently conduct repeated cross-sectional surveys with people with lived experience of drug use about their experiences and perceptions of the SASC. Final procedures will be determined in collaboration with our community partner the Lived Expertise Advisory Board.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Behavioral: Sub-acute stabilizationThe sub-acute stabilization center will combine: 1) post-overdose medical and social support, 2) the offer of starting medications for opioid use disorder, and 3) harm reduction services and supplies. |
| Comparison | No intervention | –Eligible Seattle EMS patients who opt not to go to the sub-acute stabilization center, and King County residents, outside of Seattle, who meet the same eligibility criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Verbally consents to transfer of care to SASC.
- Awake and oriented to person and place, with no significant deficits in mental status or neurological function.
- Age >=18
- Patent airway and effective respirations with adequate oxygenation.
- Stable heart rate and blood pressure, with no evidence of cardiac arrhythmias or other significant cardiovascular disfunction.
Key exclusion criteria (1 listed)
- People under 18 and who do not meet SASC admission criteria will be excluded.
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 |
|---|---|---|
| Sub-acute stabilizationThe sub-acute stabilization center (SASC) is for people who have had or are at risk for having an opioid overdose and have an encounter with Seattle Fire Department emergency medical services (EMS) in Seattle, WA. Those transported to the SASC are the intervention participants and two comparison groups will be utilized: eligible Seattle EMS patients who opt not to go to the SASC and King County residents, outside of Seattle, who meet the same eligibility criteria. A comparative interrupted time series analysis is planned to study the main effectiveness outcomes. Seattle Fire EMS will assess, refer, and arrange transport participants to the SASC. The SASC will offer an array of services including post-overdose monitoring, utilization of buprenorphine and methadone for the treatment opioid use disorder and opioid withdrawal, linkage to ongoing care for OUD, and provision of harm reduction services and supplies. The length of stay in the SASC will be limited to less than 24 hours. | Behavioural | Intervention |
Primary outcome
Repeat opioid overdose
Time frame: 1 year
One of more opioid overdoses after enrollment
MOUD initiation
Time frame: 1 year
Starting opioid use disorder treatment with buprenorphine, methadone or naltrexone
MOUD retention
Time frame: 1 year
Having one or more additional doses prescribed, administered or dispensed of buprenorphine, methadone, or naltrexone
Emergency department utilization
Time frame: 1 year
Having one or more all-cause emergency department admission
EMS utilization
Time frame: 1 year
Having one or more emergency medical service encounters
Cost-effectiveness
Time frame: 1 year
Analysis from the perspective of a public sector payer of the per unit cost of reduced opioid overdoses attributable to the diversion program
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
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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.
Caleb Banta-Green, PhD, MPH, MSW principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sub-acute stabilization in people with Opioid Use Disorder and Opioid Use, run by University of Washington 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 25 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 6 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anthony S Floyd, PhD (206-616-7382, asfloyd@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repeat opioid overdose (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2026.