- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04817410
ED Initiated Oral Naltrexone for AUD
Emergency Department Initiated Oral Naltrexone for Patients With Moderate to Severe Alcohol Use Disorder: A Pilot Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Overview
The study will be comprised of two components outlined below:
Site Implementation Component
In this component implementation science strategies will be used to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability and linkage pathways. Three specific aims are to, 1) optimize registered nurse (RN) driven non-targeted alcohol use screening supplemented with secondary screening using DSM-5 criteria for AUD and an SBIRT (screening, brief intervention and referral to treatment) intervention administered by trained staff. 2) During a 3-month period, use continuous quality improvement methods to decrease the time for completion of AUD screening to an interval that is acceptable to ED patients and ED providers and 3) Assess willingness to initiate oral naltrexone among ED patients with moderate to severe AUD. Ten (10) patients will be enrolled in phase 1.
- Oral Naltrexone Feasibility Component
In this component the study team aims to assess the feasibility of initiating treatment in ED patients with moderate to severe AUD on oral naltrexone, an evidence based and accepted standard of care treatment for AUD. Specifically, 1) over an 8-month period the study team aims to identify 20 patients with moderate to severe AUD eligible and interested in immediate initiation of oral naltrexone. Consenting patients will be receive a standard SBIRT intervention and be provided with immediate oral naltrexone initiation in the ED with a 14-day starter pack at the time of ED discharge. All participants will receive facilitated linkage to comprehensive out-patient care. 2) The study team aims will evaluate the impact of immediate ED initiated oral naltrexone with the primary outcome being engagement in comprehensive addiction care at 14 and 30 days post enrollment. Secondary outcomes include medication adherence, changes in daily alcohol consumption, number of heavy drinking days, hospital admissions and ED utilization, transition to long-acting injectable naltrexone and alcohol craving. 3) Lastly, the study team will collect data on recruitment and attrition rates, as well as means and standard deviations for key measures that will be needed to plan a definitive randomized controlled trial of ED-initiated oral naltrexone.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Lauren Gordon, MPH
- Email: lauren.gordon@mountsinai.org
Study Contact Backup
- Name: Ethan Cowan, MD
- Phone Number: 212-420-2652
- Email: ethan.cowan@mountsinai.org
Study Locations
-
-
New York
-
New York, New York, United States, 10003
- Mount Sinai Beth Israel
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Emergency Department patients 18 years of age or older
- Treated in the ED during screening hours
- Moderate to severe AUD as determined by DSM-5 criteria
- Able to speak and understand English
- Medically stable for an interview as determined by their primary ED provider
- Willing and able to consent to study participation
- Two points of contact available for follow-up
Exclusion Criteria:
- ED patients younger than 18 years of age
- Medically or psychiatrically unstable as determined by the ED provider
- Unable to speak or understand English
- Unable to provide consent for study participation
- Past year opioid dependence
- Urine drug screen positive for opioids
- Current or anticipated need for opioid medications for pain
- Anticipated surgical procedure within 14-day of ED visit
- Serologic evidence of liver disease (LFTs 3X normal) within 7 days of enrollment
- Cirrhosis either by PMH or self-report
- Pregnant or breastfeeding
- Lacking contact information for follow-up
- Requiring in-patient admission for medical or psychiatric reasons
- Patient receiving a sexual assault forensics exam (SAFE)
- Patient suspected of having COVID-19
- Patient is actively suicidal or homicidal
- Previously enrolled in either the implementation or feasibility phase of the study
- Be a prisoner or in police custody at the time of the index ED visit
- Be currently (anytime within the last 14 days) enrolled in formal addiction treatment, including by court order.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral Naloxone
Oral Naltrexone initiation
|
Emergency Department Initiated Oral Naltrexone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of participants enrolled and receiving formal addiction treatment at day 14
Time Frame: Day 14
|
Number of participant enrolled with engagement in care of comprehensive addiction treatment
|
Day 14
|
Number of participants enrolled and receiving formal addiction treatment at day 30
Time Frame: Day 30
|
Number of participant enrolled with engagement in care of comprehensive addiction treatment
|
Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Guidelines Regimen Information Program (GRIP) guide at day 14
Time Frame: Day 14
|
Adherence to daily oral naltrexone measured using GRIP guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor.
|
Day 14
|
Guidelines Regimen Information Program (GRIP) guide at day 30
Time Frame: Day 30
|
Adherence to daily oral naltrexone measured using GRIP guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor.
|
Day 30
|
Number of pills in bottle at day 14
Time Frame: Day 14
|
Adherence to daily oral naltrexone measured using pill counts.
|
Day 14
|
Number of pills in bottle at day 30
Time Frame: Day 30
|
Adherence to daily oral naltrexone measured using pill counts.
|
Day 30
|
Number of drinks
Time Frame: up to 30 days
|
Daily alcohol intake self reported via a text-messaging application
|
up to 30 days
|
Number of Heavy Drinking Days
Time Frame: up to 30 days
|
Number of heavy drinking days defined as 4 or more drinks for a woman or 5 or more drinks for a man on the same occasion in a 24 hour period.
|
up to 30 days
|
Health Services Utilization Survey
Time Frame: Day 30
|
A brief, structured measure (not scored) regarding health care utilization (inpatient and outpatient) will be used, which collects information on the type and amount of services received.
This includes ED visits, hospitalizations, primary medical care visits.
|
Day 30
|
Number of participants who Transition to LA Injectable
Time Frame: Day 30
|
Number of participants who transition from oral to long acting injectable naloxone.
|
Day 30
|
Health Related Quality of Life (HRQoL)
Time Frame: Day 30
|
HRQoL - full scale score ranges from 0 to 100, higher score indicates better health outcomes
|
Day 30
|
The Patient Rated Inventory of Side Effects (PRISE) survey
Time Frame: Day 30
|
Medication side effects of oral naltrexone measured using PRISE survey - is a patient self-report measure used to identify and evaluate the tolerability of side effect symptom.
This scale is a 7 item assessment of the side effects in the following symptom areas; gastrointestinal, heart, skin, nervous system, eyes/ears, genital/urinary, sleep, sexual functioning, and other.
Each domain has multiple symptoms and for each domain the patient rates whether these symptoms are tolerable or distressing.
Higher score represents more side-effects.
|
Day 30
|
Daily alcohol craving scale
Time Frame: up to 30 days
|
Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity.
|
up to 30 days
|
AUD Program Satisfaction Survey
Time Frame: Day 30
|
Satisfaction with the naloxone initiation program measured using Satisfaction survey - full scale from 0 to 36 higher score represents more satisfaction.
|
Day 30
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ethan Cowan, MD, Icahn School of Medicine at Mount Sinai
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-21-00278
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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