Alcohol Use DisorderPhase 1NCT04817410
ED Initiated Oral Naltrexone for AUD
A Phase 1 study testing Emergency Department Initiated Oral Naltrexone in people with Alcohol Use Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder (AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two phases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Emergency Department Initiated Oral Naltrexone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2021to 2 Nov 2023
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergency Department Initiated Oral Naltrexone for Patients With Moderate to Severe Alcohol Use Disorder: A Pilot Feasibility Study
This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder (AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two phases. The first phase (N=10) will use implementation science strategies to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability, and linkage pathways. The second phase (N=20) will incorporate lessons learned from phase 1 to initiate ED patients on MAT for AUD in the form of oral naltrexone. The primary outcome for both phase 1 and phase 2 is engagement in comprehensive addiction treatment at 14 and 30 days post enrollment.
Read the 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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Emergency Department Initiated Oral Naltrexone
- Keywords
- Medication Assisted Treatment, Emergency Department, Naltrexone
- Medical subject headings
- Alcoholism, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Department Initiated Oral NaltrexoneDrug
Emergency Department Initiated Oral Naltrexone
| Study group | Role | What they receive |
|---|---|---|
| Oral Naloxone | Experimental | Oral Naltrexone initiation Receives: Drug: Emergency Department Initiated Oral Naltrexone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14
Number of participant enrolled with engagement in care of comprehensive addiction treatment
Measured: Day 14
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 30
Number of participant enrolled with engagement in care of comprehensive addiction treatment
Measured: Day 30
Secondary outcomes (13)
Number of Alcoholic Drinks Per Day
Baseline
Measured: 7-days prior to enrollment to day of enrollment (baseline)
Number of Daily Drinks
30-days
Measured: 30-days
Daily Alcohol Craving Scale
Daily alcohol craving scale using Qualtrics - Full scale from 0 to 36, higher score represents more severity.
Measured: up to 30 days
Guidelines Regimen Information Program (GRIP) Guide at Day 14
Adherence to daily oral naltrexone measured using Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores mean better adherence.
Measured: Day 14
Guidelines Regimen Information Program (GRIP) Guide at Day 30
Adherence to daily oral naltrexone measured using the Guidelines Regimen Information Program (GRIP) guide - GRIP guide is a self-report to assess adherence, with 6 categorical items: excellent, very good, good, fair, poor, and very poor. The maximum value is 6 and the minimum value is 1. Higher scores represent better adherence.
Measured: Day 30
Number of Pills in Bottle at Day 14
Adherence to daily oral naltrexone measured using pill counts.
Measured: Day 14
Number of Pills in Bottle at Day 30
Adherence to daily oral naltrexone measured using pill counts.
Measured: Day 30
Number of Heavy Drinking 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.
Measured: up to 30 days
Health Services Utilization Survey
Participants indicated the number of inpatient admissions, outpatient visits and emergency department visits over the preceding 7-days at baseline up to 30-days. Comparison of total reported admissions or visits were made using the Friedman test. No admissions or visits counted as a 0 for comparing across timepoints. If no response was provided at any of the three time points, the participant data was not used in the comparison.
Measured: up to 30-days
Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL)
Number of unhealthy days using the HRQoL. The HRQoL assesses core health days and activity limitations. Self-reported general health was collected on a 5-item scale ranging from: excellent, very good, good, fair, and poor. An unhealthy days score was obtained by summing the number of physically unhealthy and mentally unhealthy days. The minimum score is 0 and the maximum score is 30 unhealthy days, even if the number of unhealthy days totals more than 30. If no response was provided at the time points under comparison, the participant data was not used in the comparison.
Measured: Day 30
The Patient Rated Inventory of Side Effects (PRISE) Survey
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. What is reported below are the number of participants reporting side effects for each symptom.
Measured: Day 30
AUD Program Satisfaction Survey at Baseline
Three elements of satisfaction were assessed: 1) convenience of screening, 2) difficulty of screening and 3) satisfaction with screening. Each question could be scored on scale of 0-6. For convenience of screening, lower numbers indicated more convenience. For difficulty of screening, lower numbers represent less difficulty. For satisfaction, higher numbers represent greater satisfaction.
Measured: Baseline
Number of Participants Who Transition to LA Injectable
Number of participants who transition from oral to long acting injectable naloxone.
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start28 Sep 2021
- Primary completion31 Oct 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ethan Cowan, Icahn School of Medicine at Mount Sinai
- Investigators
- Ethan Cowan, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817410
- Sponsor's protocol ID
- IRB-21-00278
- Status last verified
- Aug 2025
- First submitted
- 23 Mar 2021
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Initiated Oral Naltrexone for Patients With Moderate to Severe Alcohol Use Disorder: A Pilot Feasibility Study
- ClinicalTrials.gov ID
- NCT04817410
- Acronym / sponsor ID
- IRB-21-00278
- Conditions
- Alcohol Use Disorder
- Keywords
- Medication Assisted Treatment, Emergency Department, Naltrexone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 28 Sep 2021 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will recruit Emergency Department (ED) patients with moderate to severe alcohol use disorder (AUD) who are interested in initiating medication assisted treatment (MAT). The study is split into two phases. The first phase (N=10) will use implementation science strategies to strengthen existing non-targeted ED based AUD screening program and optimize feasibility, acceptability, and linkage pathways. The second phase (N=20) will incorporate lessons learned from phase 1 to initiate ED patients on MAT for AUD in the form of oral naltrexone. The primary outcome for both phase 1 and phase 2 is engagement in comprehensive addiction treatment at 14 and 30 days post enrollment.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Naloxone | Experimental | Drug: Emergency Department Initiated Oral NaltrexoneOral Naltrexone initiation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (19 listed)
- 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
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 |
|---|---|---|
| Emergency Department Initiated Oral NaltrexoneEmergency Department Initiated Oral Naltrexone | Drug | Oral Naloxone |
Primary outcome
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
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
13 secondary outcomes
Number of Alcoholic Drinks Per Day
Time frame: 7-days prior to enrollment to day of enrollment (baseline)
Number of Daily Drinks
Time frame: 30-days
Daily Alcohol Craving Scale
Time frame: up to 30 days
Guidelines Regimen Information Program (GRIP) Guide at Day 14
Time frame: Day 14
Guidelines Regimen Information Program (GRIP) Guide at Day 30
Time frame: Day 30
Number of Pills in Bottle at Day 14
Time frame: Day 14
Number of Pills in Bottle at Day 30
Time frame: Day 30
Number of Heavy Drinking Days
Time frame: up to 30 days
Health Services Utilization Survey
Time frame: up to 30-days
Number of Unhealthy Days Assessed by Health Related Quality of Life (HRQoL)
Time frame: Day 30
The Patient Rated Inventory of Side Effects (PRISE) Survey
Time frame: Day 30
AUD Program Satisfaction Survey at Baseline
Time frame: Baseline
Number of Participants Who Transition to LA Injectable
Time frame: Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Ethan Cowan, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Emergency Department Initiated Oral Naltrexone in people with Alcohol Use Disorder, run by Icahn School of Medicine at Mount Sinai at 1 site 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 7 inclusion and 19 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: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Enrolled and Receiving Formal Addiction Treatment at Day 14 (time frame: Day 14). The study lists 2 primary outcomes in all. 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 26 Aug 2025.