Recruiting

Observational Study

Sponsor:

University of Washington

Code:

NCT06768814

Conditions

Opioid Use Disorder

Opioid Use

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Sub-acute stabilization

Study Details

Brief 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.

Conditions

Opioid Use Disorder

Opioid Use

Study ID

NCT06768814

Start date

Dec 15, 2024

Status verified date

May, 2026

Completion date

May 31, 2029

Anticipated

Primary completion date

May 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

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

Study Design

Enrollment

40000 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

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.

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

Sub-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.

Primary outcome measure

  • Repeat opioid overdose [ Time Frame: 1 year ]
  • MOUD initiation [ Time Frame: 1 year ]
  • MOUD retention [ Time Frame: 1 year ]
  • Emergency department utilization [ Time Frame: 1 year ]
  • EMS utilization [ Time Frame: 1 year ]
  • Cost-effectiveness [ Time Frame: 1 year ]

Central Contacts and Locations

Central contacts

Anthony S Floyd, PhD

206-616-7382asfloyd@uw.edu

Locations

Downtown Emergency Service Center's Overdose Recovery and Care Access Centers

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

University of Washington

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Washington on 2026-05-06.