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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
United States2 sites, 2 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Standard education | Active comparator | 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. Receives: Behavioral: Standard education |
| Enhanced Overdose Education (EOE) | Experimental | 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. Receives: Behavioral: Enhanced Overdose Education (EOE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prescription fill rate
Pharmacy records/survey to determine if naloxone kit prescription was filled
Measured: 1 month
Secondary outcomes (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.
- First posted26 May 2023
- Study start1 Mar 2024
- Primary completion31 Aug 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid OverdoseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hartford Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hartford HealthCare
- Responsible party
- Sponsor
- Investigators
- Jonathan C Allen, MD, Principal investigator, Hartford HealthCare
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Availability of Intranasal Naloxone Rescue for Opioid Overdose
- ClinicalTrials.gov ID
- NCT05877118
- Acronym / sponsor ID
- HHC-2023-0079
- Conditions
- Opioid Overdose
- Keywords
- Naloxone, Overdose education
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Hartford HospitalUniversity, hospital or other
- Collaborators
- Hartford HealthCare
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 26 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Standard education | Active comparator | Behavioral: Standard educationWritten 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. |
| Enhanced Overdose Education (EOE) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Behavioural | Enhanced Overdose Education (EOE) |
| Standard educationWritten instructions that accompany a kit prescription in many EDs throughout the country. | Behavioural | Standard education |
Primary outcome
Prescription fill rate
Time frame: 1 month
Pharmacy records/survey to determine if naloxone kit prescription was filled
1 secondary outcome
Education content survey
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan C Allen, MD principal investigator
Hartford HealthCare
2 sites in 1 country: see every site and its status.
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.