NCT05827159 · Yale University
Emergency Department-Initiated Medications for Alcohol Use Disorder
What this study is about
The proposed study will be the first randomly assigned 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).
View original scientific description
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.
Interventions
DRUG
Naltrexone Pill
In the MAUD component, some participants will receive oral Naltrexone in the ED.
DRUG
Naltrexone Injection
In the MAUD component, some participants will receive a dose of XR-NTX (injection) in the ED.
BEHAVIORAL
Brief Negotiation Interview
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.
DRUG
Gabapentin Pill
In the MAUD component, ancillary treatment with gabapentin will be provided.
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- 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
Where
- New Haven, Connecticut
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 18, 2025 · Source of record for eligibility and locations