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Opioid OverdoseNCT05877118

Improving Availability of Intranasal Naloxone

A study testing Enhanced Overdose Education (EOE) and Standard education in people with Opioid Overdose, run by Hartford Hospital at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

While there is a lifesaving medication called naloxone that can reverse the deadly effects of opioid overdose, patients often fail to fill the prescription at the pharmacy when it is prescribed. Read more about this study

Who is it for?
Ages 21 to 65 years
Conditions the study is for
Opioid Overdose
What is being tested?
Enhanced Overdose Education (EOE) and Standard education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
2 sitesUnited States
Study dates
1 Mar 2024to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

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 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • -Patients will be in the process of being discharged from Hartford Hospital ED with a naloxone kit prescription following opiate or opioid intoxication/poisoning, use of illicit opioids or prescription opioids, or opioid injection use-related conditions

Who cannot join

  • Patient has previously received the standard naloxone kit education or has a known allergy to naloxone and/or kit constituents
  • Patient or support network does not speak English
  • Patient is in police custody
  • Patient is not being discharged home from the ED.

Trial locations and contacts

2 sites in 1 country.

Jimmy Choi, PsyD contact

860-545-7128

jimmy.choi@hhchealth.org

United States2 sites, 2 recruiting
  • Hartford Hospital Emergency Department

    Hartford, Connecticut, 06106

    David Pepper, MD

    Recruiting
  • Olin Neuropsychiatry Research Center

    Hartford, Connecticut, 06106

    Jimmy Choi, PsyD, jimmy.choi@hhchealth.org

    Michael Stevens, PhD

    Recruiting

Other trials in United States

About this study

Official title: Improving Availability of Intranasal Naloxone Rescue for Opioid Overdose

While there is a lifesaving medication called naloxone that can reverse the deadly effects of opioid overdose, patients often fail to fill the prescription at the pharmacy when it is prescribed. This is particularly concerning and true in those at the highest risk of death-those who end up in the emergency department for opioid overdose. The goal of this study is to compare the impact of different overdose education on naloxone prescription fill rates in opioid users being discharged from our hospital emergency department. You will receive either (a) written education about naloxone through their MyChart account, or (b) a concise one-page handout and 4-minute video clip reviewed with the participant and a support individual (family/friend) prior to discharge.

Read the detailed description

The rates of opioid overdose and overdose deaths in Connecticut have increased dramatically in the past decade. While there is a lifesaving medication called naloxone that can reverse the deadly effects of opioid overdose, patients often fail to fill the prescription at the pharmacy when it is prescribed. This is particularly concerning and true in those at the highest risk of death-those who end up in the emergency department for opioid overdose. Indeed, a recent national study by the University of Michigan found that from 2001 to 2016 less than 1% of patients filled their prescription for naloxone following ED discharge. To address this problem, The investigators propose a prospective randomized clinical trial comparing an experimental education intervention that may improve prescription fill rate against the current standard of care at the Hartford Hospital ED (HH-ED). Our primary aim is to provide preliminary data on the impact of an enhanced overdose education (EOE) delivered at the HH-ED, on intranasal naloxone rescue kit prescription fill rates in opioid users. The investigators hypothesize that compared to those who receive standard education (written instructions, current standard of care), opioid users who receive EOE while being discharged from the emergency department will be more likely to fill the prescription for an intranasal naloxone rescue kit within one month of hospital discharge. Our secondary aim is to obtain preliminary data on the impact of EOE, delivered at the HH-ED, on naloxone rescue kit knowledge. The investigators hypothesize that compared to the current standard education, opioid users and their support network, who receive EOE while being discharged from the emergency department, will retain more educational content about naloxone rescue kits at one-month post ED visit. In exploratory fashion, the investigators will also qualitatively examine reasons the kit was or was not filled. The long-term, overarching goal of this line of research is to reduce mortality in opioid users, starting with increasing the likelihood that rescue kit prescriptions will be filled.

Conditions
Opioid Overdose
Being tested
Enhanced Overdose Education (EOE), Standard education
Keywords
Naloxone, Overdose education
Medical subject headings
Opiate Overdose

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Enhanced Overdose Education (EOE)Behavioural

    EOE was adapted by Co-I Dr. Monique Miley at HHC's premier addiction hospital-The Rushford Center. It follows the guidelines set by Co-PI Jonathan Craig Allen when working with opioid patients reluctant to obtain naloxone:

    • Express confidence in naloxone
    • Provide a clear statement about suitability (You are an excellent candidate for naloxone)
    • Begin discussion using presumptive language (You must be ready for an overdose)
  • Standard educationBehavioural

    Written instructions that accompany a kit prescription in many EDs throughout the country.

Study groups in NCT05877118
Study groupRoleWhat they receive
Standard educationActive comparatorWritten instructions and information communicated to the patient through MyChart. The following four key points are covered: (1) When someone overdoses on opiates, their breathing will get very slow and may stop (2) Naloxone is a safe life-saving medication that can reverse an opioid overdose (3) You give someone naloxone by injecting it through the nostril, (4) If a first dose of naloxone does not work after about 3 minutes, give a second dose.
Receives: Behavioral: Standard education
Enhanced Overdose Education (EOE)ExperimentalA one-page education pamphlet handed to participants and their identified support individual and a 4-minute video clip that will be viewed in the hospital and emailed or texted to both. EOE is purposefully brief and intended to increase uptake by participants and their support network who may not be motivated or willing to engage in face-to-face or extensive education. The pamphlet and video both emphasize the Why and How. That is, the significance of naloxone in decreasing the likelihood of death following an overdose while providing simple instructions on how to use the nasal kit. They also emphasize an important point missing in standard education: to tell others in the support network where it is and how to use it.
Receives: Behavioral: Enhanced Overdose Education (EOE)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prescription fill rate

    Pharmacy records/survey to determine if naloxone kit prescription was filled

    Measured: 1 month

Secondary outcomes (1)
  1. Education content survey

    Questionnaire measuring how much of education was retained and reasons for filling or not filling prescription

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2023
  2. Study start1 Mar 2024
  3. Primary completion31 Aug 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical trial
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05877118
Sponsor's protocol ID
HHC-2023-0079
Status last verified
Jun 2024
First submitted
17 May 2023
Last updated
7 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Enhanced Overdose Education (EOE) and Standard education in people with Opioid Overdose, run by Hartford Hospital at 2 sites 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 1 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jimmy Choi, PsyD (860-545-7128, jimmy.choi@hhchealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prescription fill rate (time frame: 1 month). 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 7 Jun 2024.

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