ClinicalTrials.gg
Sign In
RecruitingNCT06768814Updated May 6, 2026

Overdose Recovery and Care Access (ORCA) Qualitative Stakeholder Interviews and County-level Data

An interventional study of Sub-acute stabilization in Opioid Use Disorder and Opioid Use, sponsored by University of Washington. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-06.

Sponsored by University of Washington · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40,000
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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

  1. 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

  2. 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.

  3. 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.
02

Conditions studied

  • Opioid Use Disorder
  • Opioid Use

Keywords

  • opioid overdose
  • opioid poisoning
  • harm-reduction
  • sub-acute stabilization
03

In context

Opioid-Related Disorders

1,472 studies on the registry are indexed under Opioid-Related Disorders; 290 are open to participants now.

This study's planned enrollment of 40,000 is above the median of 63 across 1,166 interventional studies indexed under Opioid-Related Disorders.

Browse Opioid-Related Disorders studies →

Lead sponsor

University of Washington is the lead sponsor of 1,433 studies on the registry; 225 are open to participants now.

Of its 158 completed or terminated interventional studies of FDA-regulated products, 136 (86%) have results posted.

Browse University of Washington studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Verbally consents to transfer of care to SASC.
  2. Awake and oriented to person and place, with no significant deficits in mental status or neurological function.
  3. Age >=18
  4. Patent airway and effective respirations with adequate oxygenation.
  5. Stable heart rate and blood pressure, with no evidence of cardiac arrhythmias or other significant cardiovascular disfunction.

  6. Vitals:

    • 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

  7. 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.
  8. No signs of other traumatic injury or medical needs requiring immediate treatment.
  9. No signs of respiratory infection. Screen for COVID-19. See COVID-19 Screening protocol.

Exclusion criteria

Exclusion Criteria:

- People under 18 and who do not meet SASC admission criteria will be excluded.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
40,000 participants (estimated)

Study arms

  • Other
    Intervention

    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.

    Behavioral: Sub-acute stabilization

  • No intervention
    Comparison

    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.

Interventions

  • BehavioralSub-acute stabilization

    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.

06

What researchers measure

Primary outcomes

  1. Repeat opioid overdose

    One of more opioid overdoses after enrollment

    Time frame: 1 year

  2. MOUD initiation

    Starting opioid use disorder treatment with buprenorphine, methadone or naltrexone

    Time frame: 1 year

  3. MOUD retention

    Having one or more additional doses prescribed, administered or dispensed of buprenorphine, methadone, or naltrexone

    Time frame: 1 year

  4. Emergency department utilization

    Having one or more all-cause emergency department admission

    Time frame: 1 year

  5. EMS utilization

    Having one or more emergency medical service encounters

    Time frame: 1 year

  6. 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

    Time frame: 1 year

Other outcomes

  1. Service utilization patterns

    Changes in the way services or opioid-related emergencies are provided and changes to cascade of care changes over time (descriptive).

    Time frame: 1 year

  2. Staff observations

    How care opioid-related care is viewed by SASC staff members (descriptive).

    Time frame: 1 year

  3. Continuous process improvement (CPI) partner observations

    How care opioid-related care is viewed by CPI partners and participants (descriptive).

    Time frame: 1 year

07

Study locations

1 of 1 sites recruiting
  • Downtown Emergency Service Center's Overdose Recovery and Care Access Centers
    Seattle, Washington 98104, United States
    Recruiting
    • Daniel Malone · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2024 (actual). Primary completion is estimated for May 2028, 41 months after the start.

Of 464 non-industry interventional studies with no phase under Opioid-Related Disorders, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 47. This study's planned 41 months is above that.

Counting every sponsor, half of 495 studies reached it within 29 months; a quarter within 13 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 6, 2025
First posted
Jan 10, 2025
StartActual
Dec 15, 2024
Primary completionEst.
May 31, 2028
CompletionEst.
May 31, 2029
Last update
May 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06768814
Lead sponsor
University of Washington
Collaborators
National Institute on Drug Abuse (NIDA)
Responsible party
Caleb Banta-Green (Research Professor, School of Medicine, Psychiatry, University of Washington) — Principal investigator
First posted
Jan 10, 2025
Start date
Dec 15, 2024
Primary completion
May 31, 2028 (estimated)
Completion
May 31, 2029 (estimated)
Last update
May 6, 2026

Study contacts

Anthony S Floyd, PhD
Contact
asfloyd@uw.edu
206-616-7382
Caleb Banta-Green, PhD, MPH, MSW
principal investigator · University of Washington

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Opioid-Related Disorders →

Other studies from this sponsor

University of Washington →

Start the discussion