ClinicalTrials.gg
RecruitingNCT05877118Updated Jun 7, 2024

Improving Availability of Intranasal Naloxone

An interventional study of Enhanced Overdose Education (EOE) and Standard education in Opioid Overdose, sponsored by Hartford Hospital. Recruiting at 2 sites in United States. Open to participants aged 21 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-07.

Sponsored by Hartford Hospital · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Primary completion was expected by Aug 2025, 1 year 2 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
84
Allocation
Randomized
Ages
21 Years to 65 Years
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Opioid Overdose

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Keywords

  • Naloxone
  • Overdose education
03

In context

Opiate Overdose

70 studies on the registry are indexed under Opiate Overdose; 11 are open to participants now.

This study's planned enrollment of 84 is below the median of 184 across 48 interventional studies indexed under Opiate Overdose.

Browse Opiate Overdose studies →

Lead sponsor

Hartford Hospital is the lead sponsor of 105 studies on the registry; 20 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 5 (36%) have results posted.

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

04

Who can participate

Ages eligible
21 Years to 65 Years
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

-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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
84 participants (estimated)

Study arms

  • Active comparator
    Standard education

    Written 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.

    Behavioral: Standard education

  • Experimental
    Enhanced Overdose Education (EOE)

    A 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.

    Behavioral: Enhanced Overdose Education (EOE)

Interventions

  • BehavioralEnhanced Overdose Education (EOE)

    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)

  • BehavioralStandard education

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

06

What researchers measure

Primary outcomes

  1. Prescription fill rate

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

    Time frame: 1 month

Secondary outcomes

  1. Education content survey

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

    Time frame: 1 month

07

Study locations

2 of 2 sites recruiting
  • Hartford Hospital Emergency Department
    Hartford, Connecticut 06106, United States
    Recruiting
    • David Pepper, MD · Contact
  • Olin Neuropsychiatry Research Center
    Hartford, Connecticut 06106, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05877118
Lead sponsor
Hartford Hospital
Collaborators
Hartford HealthCare
Responsible party
Sponsor
First posted
May 26, 2023
Start date
Mar 1, 2024
Primary completion
Aug 31, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 7, 2024

Study contacts

Jimmy Choi, PsyD
Contact
jimmy.choi@hhchealth.org
860-545-7128
Jonathan C Allen, MD
principal investigator · Hartford HealthCare

Oversight

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

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