Improving Availability of Intranasal Naloxone

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Hartford Hospital
Study ID
NCT05877118
Status
Recruiting
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Conditions

  • Opioid Overdose

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Enhanced Overdose Education (EOE) — BEHAVIORAL
    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 education — BEHAVIORAL
    Written instructions that accompany a kit prescription in many EDs throughout the country.

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
Jun 2024
Primary completion
Aug 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
84 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.
  • 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.

Primary Outcome Measure

Prescription fill rate [ Time Frame: 1 month ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Hartford Hospital Emergency DepartmentHartfordConnecticut06106
David Pepper, MD
Olin Neuropsychiatry Research CenterHartfordConnecticut06106
Jimmy Choi, PsyD
[email protected]
Michael Stevens, PhD (SUB_INVESTIGATOR)

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By research site
Hartford Hospital Emergency Department· Hartford, CTOlin Neuropsychiatry Research Center· Hartford, CT

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