Recruiting

Intranasal Naloxone

Sponsor:

Hartford Hospital

Code:

NCT05877118

Conditions

Opioid Overdose

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

Interventions

Enhanced Overdose Education (EOE)

Standard education

Study Details

Brief 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.

Conditions

Opioid Overdose

Study ID

NCT05877118

Start date

Mar 1, 2024

Status verified date

Jun, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Aug 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 65

Healthy Volunteers: Not accepted

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:

  • 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.

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

Enhanced 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)

Standard education

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

Primary outcome measure

  • Prescription fill rate [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Jimmy Choi, PsyD

860-545-7128jimmy.choi@hhchealth.org

Locations

Hartford Hospital Emergency Department

Recruiting

Hartford, Connecticut, United States, 06106

Olin Neuropsychiatry Research Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Jimmy Choi, PsyD

jimmy.choi@hhchealth.org

More Information

Sponsor

Hartford Hospital

Last update posted

Jun 7, 2024

Last verified

Jun, 2024

Keywords

  • Naloxone
  • Overdose education

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford Hospital on 2024-06-07.