RECRUITINGPhase 3INTERVENTIONAL

Emergency Department-Initiated Medications for Alcohol Use Disorder

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Between 18 and 80 years in age 2. Diagnosed with moderate to severe Alcohol Use Disorder 3. Stated willingness and ability to comply with all study procedures and availability for the duration of the study 4. 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 5. Able to speak English sufficiently to understand study procedures and provide written willing to sign a consent form to participate in the study. 6. Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4. Who Should NOT Join This Trial: 1. 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) 2. Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery) 3. History of complicated alcohol withdrawal 4. Condition that precludes interview (i.e., life threatening injury/illness) 5. Inability to consent due to cognitive impairment 6. Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation 7. In police custody 8. Unable to provide contact information 9. Previously enrolled in this study or currently enrolled in another study for which they are currently receiving study medications or active ongoing intervention 10. 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). 11. Creatine Clearance \<60 mL/min within past 72 hours. 12. Currently pregnant or breast feeding 13. Requiring hospitalization at the time of the index visit 14. Past week treatment with medications for the treatment of alcohol use disorder ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Between 18 and 80 years in age 2. Diagnosed with moderate to severe Alcohol Use Disorder 3. Stated willingness and ability to comply with all study procedures and availability for the duration of the study 4. 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 5. Able to speak English sufficiently to understand study procedures and provide written informed consent to participate in the study. 6. Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4. Exclusion Criteria: 1. 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) 2. Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery) 3. History of complicated alcohol withdrawal 4. Condition that precludes interview (i.e., life threatening injury/illness) 5. Inability to consent due to cognitive impairment 6. Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation 7. In police custody 8. Unable to provide contact information 9. Previously enrolled in this study or currently enrolled in another study for which they are currently receiving study medications or active ongoing intervention 10. 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). 11. Creatine Clearance \<60 mL/min within past 72 hours. 12. Currently pregnant or breast feeding 13. Requiring hospitalization at the time of the index visit 14. Past week treatment with medications for the treatment of alcohol use disorder 15. Taking gabapentin or naltrexone for any reason 16. Appearing unable or unwilling to comply with discharge instructions or complete follow-up 17. Current residence outside of the state of Connecticut

Treatments Being Tested

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.

Locations (1)

Yale New Haven Hospital

New Haven, Connecticut, United States