Sub-acute Stabilization for Opioid Overdose

Overseen By Anthony S Floyd, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Must be taking: Buprenorphine, Methadone

Disqualifiers: Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

40000 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial involves the use of buprenorphine and methadone for opioid use disorder, it's possible that adjustments to your current medications might be needed. Please consult with the trial coordinators for specific guidance.

Is the sub-acute stabilization treatment for opioid overdose safe for humans?

The research articles reviewed do not provide specific safety data for sub-acute stabilization treatment for opioid overdose. However, they discuss the use of naloxone, a common treatment for opioid overdose, which is generally considered safe when administered by paramedics, although some adverse events may occur. ^{1 2 3 4 5}

How does sub-acute stabilization treatment for opioid overdose differ from other treatments?

Sub-acute stabilization for opioid overdose is unique because it focuses on stabilizing patients after the initial emergency treatment, potentially involving ongoing care and monitoring to prevent further complications. This approach may differ from standard emergency treatments like naloxone, which are primarily used for immediate overdose reversal. ^{3 6 7 8 9}

Research Team

Caleb Banta-Green, PhD, MPH, MSW

Principal Investigator

University of Washington

Eligibility Criteria

This trial is for individuals in Seattle who have had or are at risk of an opioid overdose and interact with the city's EMS. Participants will be compared to those who decline the service and similar individuals outside Seattle.

Inclusion Criteria

Verbally consents to transfer of care to SASC

I can breathe well on my own without assistance.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Intervention

Participants are transported to the sub-acute stabilization center (SASC) for post-overdose monitoring, initiation of medications for opioid use disorder, and provision of harm reduction services.

Less than 24 hours

1 visit (in-person)

Implementation Research Interviews

Repeated cross-sectional interviews with professional stakeholders about the implementation of the SASC and CPI activities.

Ongoing

Virtual interviews

Follow-up

Participants are monitored for safety and effectiveness after intervention, including repeat opioid overdose, MOUD initiation and retention, and emergency department utilization.

1 year

Treatment Details

Interventions

• Sub-acute stabilization

Trial Overview The study tests a sub-acute stabilization center (SASC) offering services like post-overdose monitoring, medication-assisted treatment, ongoing care linkage for OUD, and harm reduction supplies. The effectiveness will be measured against two comparison groups.

Participant Groups

Group I: Intervention Experimental Treatment 1 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.

Group II: Comparison Active Control 1 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 Is Running the Clinical Trial?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Opioid dosage is the most consistently identified risk factor for overdose in patients receiving opioid analgesics, highlighting the need for careful dosage management.

Concurrent use of sedative-hypnotics, extended-release/long-acting opioids, and comorbid substance use or mental health disorders also significantly increase the risk of overdose, indicating that these factors should be closely monitored in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding Risk Factors for Opioid Overdose in Clinical Populations to Inform Treatment and Policy. Park, TW., Lin, LA., Hosanagar, A., et al.[2022]

In a study of 1192 opioid overdose episodes treated with naloxone by paramedics, 45% of patients experienced adverse events, primarily related to opioid withdrawal, but most were non-serious.

Despite the high frequency of adverse events, serious complications were rare, with only 0.3% of cases requiring hospitalization, indicating that naloxone administration in out-of-hospital settings is generally safe and effective in saving lives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events after naloxone treatment of episodes of suspected acute opioid overdose. Buajordet, I., Naess, AC., Jacobsen, D., et al.[2022]

In a study of 77 patients who experienced acute opioid overdose, over 60% were stabilized with just one dose of an antidote, indicating effective immediate treatment in emergency settings.

Despite quick stabilization, 64% of patients left the hospital against medical advice after an average stay of less than 6 hours, highlighting a need for better follow-up care and counseling options for opioid users.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

After antagonization of acute opiate overdose: a survey at hospitals in Vienna. Seidler, D., Stühlinger, GH., Fischer, G., et al.[2019]

In a study of 46,952 hospital patients, 158 received naloxone due to opioid-related issues, highlighting the ongoing risk of opioid oversedation in hospitalized patients.

The study suggests that implementing better sedation assessments and coordinated pain management strategies could help prevent the need for naloxone by reducing the reliance on opioids and minimizing the use of multiple sedating medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of required sedation assessment in nursing workflow to address naloxone utilization. Hardison, E., Bloomer, A., Wally, MK., et al.[2023]

Among over 1.1 million adolescents studied, only 0.06% experienced an opioid overdose, indicating that while the risk exists, it is relatively low for previously opioid-naive individuals.

Receiving more than 30 opioid tablets significantly increased the risk of overdose by 35%, and tramadol was found to pose a 2.67-fold higher risk of overdose compared to oxycodone, especially in adolescents with preexisting mental health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Associations Between Opioid Prescribing Patterns and Overdose Among Privately Insured Adolescents. Groenewald, CB., Zhou, C., Palermo, TM., et al.[2020]

A study of 10,454 heroin users in Italy found that being in treatment significantly reduces the risk of overdose mortality, with a hazard ratio of 0.09 compared to those out of treatment.

However, there is a heightened risk of fatal overdose immediately after treatment ends, with a hazard ratio of 26.6 in the first month, highlighting the need for better education and prevention programs for users transitioning out of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of fatal overdose during and after specialist drug treatment: the VEdeTTE study, a national multi-site prospective cohort study. Davoli, M., Bargagli, AM., Perucci, CA., et al.[2012]

In a study of 726 presumed opioid overdose patients treated by emergency medical services, 94% responded positively to naloxone, indicating its high efficacy in reversing opioid overdoses in an out-of-hospital urban setting.

Most patients (80%) who had an initial blood pressure received naloxone intramuscularly, and the response rates were similar for both intramuscular and intravenous administration, demonstrating that naloxone is effective regardless of the route of delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Out-of-hospital treatment of opioid overdoses in an urban setting. Sporer, KA., Firestone, J., Isaacs, SM.[2022]

The new 4 mg intranasal naloxone formulation (Narcan®) was highly effective in reversing opioid overdoses, with a success rate of 98.8% reported in 242 out of 245 cases surveyed by first responders and community organizations.

Most overdose reversals occurred quickly, with 73.5% of cases responding within 5 minutes, highlighting the formulation's rapid action in emergency situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of naloxone nasal spray 4 mg in the community setting: a survey of use by community organizations. Avetian, GK., Fiuty, P., Mazzella, S., et al.[2019]

Fatal opioid overdoses are a significant public health issue, with known risk factors like loss of tolerance and the use of alcohol or other CNS depressants, but the exact mechanisms behind these fatalities remain unclear.

The paper suggests that underlying health issues, particularly pulmonary and hepatic dysfunction, may increase the risk of both fatal and non-fatal overdoses, highlighting the need for more epidemiological data on the long-term health impacts of non-fatal overdoses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heroin overdose: causes and consequences. Warner-Smith, M., Darke, S., Lynskey, M., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Understanding Risk Factors for Opioid Overdose in Clinical Populations to Inform Treatment and Policy. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Adverse events after naloxone treatment of episodes of suspected acute opioid overdose. [2022]

3. England pubmed.ncbi.nlm.nih.gov

After antagonization of acute opiate overdose: a survey at hospitals in Vienna. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Implementation of required sedation assessment in nursing workflow to address naloxone utilization. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Associations Between Opioid Prescribing Patterns and Overdose Among Privately Insured Adolescents. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Risk of fatal overdose during and after specialist drug treatment: the VEdeTTE study, a national multi-site prospective cohort study. [2012]

7. United States pubmed.ncbi.nlm.nih.gov

Out-of-hospital treatment of opioid overdoses in an urban setting. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Use of naloxone nasal spray 4 mg in the community setting: a survey of use by community organizations. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Heroin overdose: causes and consequences. [2019]