Alcohol Use DisorderPhase 3NCT05827159
Emergency Department-Initiated Medications for Alcohol Use Disorder
A Phase 3 study testing Naltrexone Pill, Naltrexone Injection and Brief Negotiation Interview in people with Alcohol Use Disorder, run by Yale University at 1 site in United States.
Trial summary
The proposed study will be the first randomized clinical trial to evaluate a comprehensive Emergency Department (ED)-based intervention for moderate to severe Alcohol Use Disorder (AUD) combining Screening, Brief Intervention and Referral to Treatment (SBIRT) with ED-initiated medications for treatment of alcohol use… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Naltrexone Pill, Naltrexone Injection and Brief Negotiation Interview
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Aug 2024to 1 Feb 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 18 and 80 years in age
- Diagnosed with moderate to severe Alcohol Use Disorder
- Stated willingness and ability to comply with all study procedures and availability for the duration of the study
- Reproductive aged females will have a negative pregnancy test within the past 24 hours and agree to use of highly effective family planning during study participation period
- Able to speak English sufficiently to understand study procedures and provide written informed consent to participate in the study.
- Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4.
Who cannot join
- A current diagnosis of OUD, self-reported past 7 day opioid or opioid pain medication use, or a positive urine opioid screen (opiates, methadone, buprenorphine, oxycodone, hydrocodone, tramadol and fentanyl)
- Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery)
- History of complicated alcohol withdrawal
- Condition that precludes interview (i.e., life threatening injury/illness)
- Inability to consent due to cognitive impairment
- Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation
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- In police custody
- Unable to provide contact information
- Previously enrolled in this study or currently enrolled in another study for which they are currently receiving study medications or active ongoing intervention
- Any contraindication to naltrexone or gabapentin, including known allergy, renal failure, acute hepatitis, hepatic failure,1 or severe lung disease or other chronic conditions such as chronic obstructive pulmonary disease (COPD).
- Creatine Clearance <60 mL/min within past 72 hours.
- Currently pregnant or breast feeding
- Requiring hospitalization at the time of the index visit
- Past week treatment with medications for the treatment of alcohol use disorder
- Taking gabapentin or naltrexone for any reason
- Appearing unable or unwilling to comply with discharge instructions or complete follow-up
- Current residence outside of the state of Connecticut
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale New Haven Hospital
New Haven, Connecticut, 06520
Kathryn Hawk, MD, MHS, 203-688-2222, kathryn.hawk@yale.edu
Kathryn Hawk, MD, MHS
About this study
The proposed study will be the first randomized clinical trial to evaluate a comprehensive Emergency Department (ED)-based intervention for moderate to severe Alcohol Use Disorder (AUD) combining Screening, Brief Intervention and Referral to Treatment (SBIRT) with ED-initiated medications for treatment of alcohol use disorder (MAUD).
The primary objective of this phase 3 study is to evaluate for differences in treatment engagement 30 days after ED visit between emergency department patients with moderate to severe alcohol use disorder (AUD) who are randomized to initiate medications for the treatment for AUD in the ED in addition to receiving a brief intervention and referral to ongoing treatment, which all participants will receive.
The secondary objective of this study is to evaluate the difference in reduction of heavy drinking days between the two ED treatment models during the 30 days post ED visit.
Read the detailed description
The proposed study will evaluate a comprehensive ED-based intervention for moderate to severe AUD combining SBIRT with ED-initiated MAUD. It is an extension and a novel application of a highly effective ED intervention model that has been successfully developed and broadly disseminated for other conditions, such as diabetes, hypertension and more recently opioid use disorder. No prospective randomized controlled trials of ED-initiated medications for the treatment of AUD, with or without psychosocial interventions, have been published to date. If found efficacious this novel intervention model has a potential to increase AUD treatment participation rates among individuals with AUD who frequently receive care in the ED. The proposed study will evaluate two ED-based interventions that have a potential to be broadly disseminated to narrow the gap between treatment need and treatment access.
Study participants will be identified through targeted screening for DSM-5 criteria for moderate to severe AUD and the study inclusion/exclusion criteria. Therefore, the Screening component of the SBIRT intervention in the proposed RCT will be conducted before eligible ED patients who are interested in study participation are consented and randomized. This study will compare outcomes among individuals who are initiated on MAUD treatment in the ED, including AUD treatment with naltrexone, with ancillary support of gabapentin to assist with withdrawal symptoms.
Hypothesis 1: The rates of AUD treatment engagement will be higher among patients receiving SBIRT+ED-MAUD.
Hypothesis 2: Those randomized to SBIRT+ED-MAUD will have greater reductions of heavy drinking days.
This study is not designed to change the FDA labeling of gabapentin.
- Conditions
- Alcohol Use Disorder
- Being tested
- Naltrexone Pill, Naltrexone Injection, Brief Negotiation Interview, Gabapentin Pill
- Keywords
- Emergency Department, Brief Intervention, Naltrexone, Gabapentin
- Medical subject headings
- Alcoholism, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naltrexone PillDrug
Also called Oral naltrexone
In the MAUD component, some participants will receive oral Naltrexone in the ED.
Naltrexone InjectionDrug
Also called XR-NTX
In the MAUD component, some participants will receive a dose of XR-NTX (injection) in the ED.
Brief Negotiation InterviewBehavioural
Also called BNI
Brief Negotiation Interview (BNI) has four key components: (1) permission to discuss substance use, (2) feedback on the health consequences of ongoing substance use, including making a connection between the ED visit and substance use, (3) motivational enhancement, and (4) negotiation and advice.
Gabapentin PillDrug
Also called Oral gabapentin
In the MAUD component, ancillary treatment with gabapentin will be provided.
| Study group | Role | What they receive |
|---|---|---|
| SBIRT | Experimental | Participants will receive the Brief Negotiation Interview (BNI) and Referral to Treatment. The BNI has four key components: (1) permission to discuss substance use, (2) feedback on the health consequences of ongoing substance use, including making a connection between the ED visit and substance use, (3) motivational enhancement, and (4) negotiation and advice. Receives: Behavioral: Brief Negotiation Interview |
| SBIRT+ED-MAUD | Experimental | Participants with receive BNI, Referral to Treatment, and MAUD. In the MAUD component, either XR-NTX or oral naltrexone will be provided, supplemented by ancillary treatment with gabapentin. Participants will receive their first doses of XR-NTX (injection) and gabapentin in the ED and will receive 7 days of gabapentin take-home doses. Those who prefer to initiate treatment in ED with oral naltrexone receive their first doses of naltrexone and gabapentin in the ED and receive 29-day take-home doses of naltrexone and 7 days of gabapentin. Receives: Drug: Naltrexone Pill; Drug: Naltrexone Injection; Behavioral: Brief Negotiation Interview; Drug: Gabapentin Pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in AUD Treatment on Day 30 post-randomization
The proportions of participants participating in AUD treatment on day 30 post enrollment in SBIRT and SBIRT+EDMAUD groups.
Measured: 30 days post enrollment
Secondary outcomes (7)
Days of heavy alcohol drinking
The number of heavy alcohol drinking days during the 30 days prior and during 30 days post the ED index visit. This outcome will be based on self-report using the timeline follow-back (TLFB) method. A day of heavy alcohol drinking is defined by the NIAAA criteria as: for men, consuming more than 4 drinks on any day; for women, consuming more than 3 drinks on any day.
Measured: 30 days post ED visit
AUD Treatment Linkage
The proportion of participants that initiate AUD treatment within 7 days post ED visit with providers to which they were referred during the ED visit
Measured: up to 7 days post ED visit
Alcohol craving
Daily intensity of alcohol craving measured on a visual analog scale of 0 to 100.
Measured: up to 7 days post enrollment
Alcohol withdrawal symptoms
Daily intensity of alcohol withdrawal measured on a visual analog scale of 0 to 100.
Measured: up to 7 days post enrollment
Daily naltrexone medication adherence
Number of oral naltrexone doses taken in the past 24 hours for 7 days post enrollment of those initiated on oral naltrexone in the SBIRT+ED- MAUD arm.
Measured: up to 7 days post enrollment
Daily gabapentin medication adherence
Number of gabapentin doses taken in the past 24 hours of those in the SBIRT+ED- MAUD arm.
Measured: up to 7 days post enrollment
Treatment linkage
- Proportion of patients in each of the two study arms initiating outpatient AUD treatment within 7 days post the ED visit with providers to which they were referred during the ED visit.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start17 Aug 2024
- Primary completion1 Aug 2028 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study participants will be identified through targeted screening for DSM-5 criteria for moderate to severe AUD and the study inclusion/exclusion criteria. Therefore, the Screening component of the SBIRT intervention in the proposed RCT will be conducted before eligible ED patients who are interested in study participation are consented and randomized.
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Kathryn Hawk, Yale University
- Investigators
- Kathryn Hawk, MD, MHS, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827159
- Sponsor's protocol ID
- 2000034359
- Other IDs
- 1R01AA030568-01
- Status last verified
- Jul 2026
- First submitted
- 12 Apr 2023
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data available through NIAAA Data Archive
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department-Initiated Medications for Alcohol Use Disorder
- ClinicalTrials.gov ID
- NCT05827159
- Acronym / sponsor ID
- 2000034359
- Conditions
- Alcohol Use Disorder
- Keywords
- Emergency Department, Brief Intervention, Naltrexone, Gabapentin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 17 Aug 2024 (actual)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 24 Apr 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.
The proposed study will be the first randomized clinical trial to evaluate a comprehensive Emergency Department (ED)-based intervention for moderate to severe Alcohol Use Disorder (AUD) combining Screening, Brief Intervention and Referral to Treatment (SBIRT) with ED-initiated medications for treatment of alcohol use disorder (MAUD).
The primary objective of this phase 3 study is to evaluate for differences in treatment engagement 30 days after ED visit between emergency department patients with moderate to severe alcohol use disorder (AUD) who are randomized to initiate medications for the treatment for AUD in the ED in addition to receiving a brief intervention and referral to ongoing treatment, which all participants will receive.
The secondary objective of this study is to evaluate the difference in reduction of heavy drinking days between the two ED treatment models during the 30 days post ED visit.
Detailed description
The proposed study will evaluate a comprehensive ED-based intervention for moderate to severe AUD combining SBIRT with ED-initiated MAUD. It is an extension and a novel application of a highly effective ED intervention model that has been successfully developed and broadly disseminated for other conditions, such as diabetes, hypertension and more recently opioid use disorder. No prospective randomized controlled trials of ED-initiated medications for the treatment of AUD, with or without psychosocial interventions, have been published to date. If found efficacious this novel intervention model has a potential to increase AUD treatment participation rates among individuals with AUD who frequently receive care in the ED. The proposed study will evaluate two ED-based interventions that have a potential to be broadly disseminated to narrow the gap between treatment need and treatment access.
Study participants will be identified through targeted screening for DSM-5 criteria for moderate to severe AUD and the study inclusion/exclusion criteria. Therefore, the Screening component of the SBIRT intervention in the proposed RCT will be conducted before eligible ED patients who are interested in study participation are consented and randomized. This study will compare outcomes among individuals who are initiated on MAUD treatment in the ED, including AUD treatment with naltrexone, with ancillary support of gabapentin to assist with withdrawal symptoms.
Hypothesis 1: The rates of AUD treatment engagement will be higher among patients receiving SBIRT+ED-MAUD.
Hypothesis 2: Those randomized to SBIRT+ED-MAUD will have greater reductions of heavy drinking days.
This study is not designed to change the FDA labeling of gabapentin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Study participants will be identified through targeted screening for DSM-5 criteria for moderate to severe AUD and the study inclusion/exclusion criteria. Therefore, the Screening component of the SBIRT intervention in the proposed RCT will be conducted before eligible ED patients who are interested in study participation are consented and randomized.
| Arm | Type | Receives |
|---|---|---|
| SBIRT | Experimental | Behavioral: Brief Negotiation InterviewParticipants will receive the Brief Negotiation Interview (BNI) and Referral to Treatment. The BNI has four key components: (1) permission to discuss substance use, (2) feedback on the health consequences of ongoing substance use, including making a connection between the ED visit and substance use, (3) motivational enhancement, and (4) negotiation and advice. |
| SBIRT+ED-MAUD | Experimental | Drug: Naltrexone Pill, Drug: Naltrexone Injection, Behavioral: Brief Negotiation Interview, Drug: Gabapentin PillParticipants with receive BNI, Referral to Treatment, and MAUD. In the MAUD component, either XR-NTX or oral naltrexone will be provided, supplemented by ancillary treatment with gabapentin. Participants will receive their first doses of XR-NTX (injection) and gabapentin in the ED and will receive 7 days of gabapentin take-home doses. Those who prefer to initiate treatment in ED with oral naltrexone receive their first doses of naltrexone and gabapentin in the ED and receive 29-day take-home doses of naltrexone and 7 days of gabapentin. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Between 18 and 80 years in age
- Diagnosed with moderate to severe Alcohol Use Disorder
- Stated willingness and ability to comply with all study procedures and availability for the duration of the study
- Reproductive aged females will have a negative pregnancy test within the past 24 hours and agree to use of highly effective family planning during study participation period
- Able to speak English sufficiently to understand study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (17 listed)
- A current diagnosis of OUD, self-reported past 7 day opioid or opioid pain medication use, or a positive urine opioid screen (opiates, methadone, buprenorphine, oxycodone, hydrocodone, tramadol and fentanyl)
- Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery)
- History of complicated alcohol withdrawal
- Condition that precludes interview (i.e., life threatening injury/illness)
- Inability to consent due to cognitive impairment
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 |
|---|---|---|
| Naltrexone PillAlso: Oral naltrexoneIn the MAUD component, some participants will receive oral Naltrexone in the ED. | Drug | SBIRT+ED-MAUD |
| Naltrexone InjectionAlso: XR-NTXIn the MAUD component, some participants will receive a dose of XR-NTX (injection) in the ED. | Drug | SBIRT+ED-MAUD |
| Brief Negotiation InterviewAlso: BNIBrief Negotiation Interview (BNI) has four key components: (1) permission to discuss substance use, (2) feedback on the health consequences of ongoing substance use, including making a connection between the ED visit and substance use, (3) motivational enhancement, and (4) negotiation and advice. | Behavioural | SBIRT, SBIRT+ED-MAUD |
| Gabapentin PillAlso: Oral gabapentinIn the MAUD component, ancillary treatment with gabapentin will be provided. | Drug | SBIRT+ED-MAUD |
Primary outcome
Participation in AUD Treatment on Day 30 post-randomization
Time frame: 30 days post enrollment
The proportions of participants participating in AUD treatment on day 30 post enrollment in SBIRT and SBIRT+EDMAUD groups.
7 secondary outcomes
Days of heavy alcohol drinking
Time frame: 30 days post ED visit
AUD Treatment Linkage
Time frame: up to 7 days post ED visit
Alcohol craving
Time frame: up to 7 days post enrollment
Alcohol withdrawal symptoms
Time frame: up to 7 days post enrollment
Daily naltrexone medication adherence
Time frame: up to 7 days post enrollment
Daily gabapentin medication adherence
Time frame: up to 7 days post enrollment
Treatment linkage
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: Yes. Data available through NIAAA Data Archive
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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.
Kathryn Hawk, MD, MHS principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Naltrexone Pill, Naltrexone Injection and Brief Negotiation Interview in people with Alcohol Use Disorder, run by Yale University 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 6 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 21 Jul 2026. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Hawk, MD, MHS (267-334-4415, Kathryn.hawk@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in AUD Treatment on Day 30 post-randomization (time frame: 30 days post enrollment). 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 21 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.