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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness of a sub-acute stabilization center (SASC) for individuals who have experienced or are at risk for an opioid overdose in Seattle, WA. The study compares those receiving care at the SASC with two other groups: eligible individuals who choose not to attend the SASC and similar individuals from King County. The SASC provides services such as medical monitoring, medications for opioid withdrawal, and harm reduction support. Individuals who have experienced an opioid overdose, are stable, and agree to be transported to the SASC may be suitable for this trial. As an unphased trial, this study presents a unique opportunity to enhance understanding and improve care for opioid overdose patients.

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.

What prior data suggests that this sub-acute stabilization is safe for opioid overdose patients?

Studies have shown that treatments in sub-acute stabilization centers can be safe for people recovering from an opioid overdose. For example, research found that over 60% of patients stabilized with just one dose of an antidote after an opioid overdose. This indicates that the immediate care provided in these centers can be effective and well-tolerated.

Similar models to these centers have also demonstrated good results. About 63.5% of patients completed withdrawal management, and 73.4% completed residential care. These figures indicate that patients generally handle the treatment process well.

While more research is always helpful, current evidence suggests that these stabilization treatments are generally safe and can be an important step in recovery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The sub-acute stabilization for opioid overdose is unique because it combines immediate post-overdose medical care with social support, starting medications for opioid use disorder, and harm reduction services. Unlike standard treatments that might focus primarily on medical stabilization or medication, this approach offers a comprehensive package addressing both the immediate medical needs and the long-term recovery aspects. Researchers are excited because this holistic approach could potentially improve patient outcomes by providing continuous care and support, reducing the risk of future overdoses, and encouraging sustained recovery.

What evidence suggests that sub-acute stabilization is effective for opioid overdose?

This trial will compare sub-acute stabilization with a comparison group. Studies have shown that centers for short-term stabilization can assist individuals at high risk of opioid overdose. In one study of 77 patients who experienced an opioid overdose, over 60% stabilized with just one dose of a treatment. This demonstrates the effectiveness of quick medical intervention in such situations. Methadone treatment, available at these centers, has reduced the risk of death in the initial weeks of treatment. This combination of immediate care and ongoing support can be life-saving for those struggling with opioid use. ^{1 2 4 6 7}

Who Is on the Research Team?

Caleb Banta-Green, PhD, MPH, MSW

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06768814?draw=2&rank=1

Overdose Recovery and Care Access (ORCA) Qualitative ... 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 ...

2. withpower.com withpower.com/trial/phase-opioid-related-disorders-11-2024-934e6

Sub-acute Stabilization for Opioid Overdose 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 ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06768814/overdose-recovery-and-care-access-orca-qualitative-stakeholder-interviews-and-county-level-data

Overdose Recovery and Care Access (ORCA) Qualitative ... 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 ...

4. bmj.com bmj.com/content/357/bmj.j1550

Mortality risk during and after opioid substitution treatment In pooled trend analysis, all cause mortality dropped sharply over the first four weeks of methadone treatment and decreased gradually two weeks ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8986509/

Treatment of opioid overdose: current approaches and recent ... Opioid overdose deaths reached a new record of over 74,000 in a 12-month period ending April 2021. Naloxone is the primary opioid overdose ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7383778/

[image] Opioid Overdose and Addiction Treatment Equally important, the MASC treatment model is showing initial success, with completion rates of 63.5% for withdrawal management and 73.4% for residential. The ...

7. library.samhsa.gov library.samhsa.gov/sites/default/files/overdose-prevention-response-kit-pep23-03-00-001.pdf

SAMHSA Overdose Prevention and Response Toolkit 1 In addition, provisional data from CDC now show that overdose deaths have declined throughout 2024, with a projected decline of nearly 27% in ...