Clinical trial NCT05827159: Emergency Department-Initiated Medications for Alcohol Use Disorder
Official title: Emergency Department-Initiated Medications for Alcohol Use Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Alcohol Use Disorder
Keywords: Emergency Department
Brief Intervention
Naltrexone
Gabapentin
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2023-04-24
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participation in AUD Treatment on Day 30 post-randomization
timeFrame: 30 days post enrollment
Secondary outcomes:
measure: Days of heavy alcohol drinking
timeFrame: 30 days post ED visit
measure: AUD Treatment Linkage
timeFrame: up to 7 days post ED visit
measure: Alcohol craving
timeFrame: up to 7 days post enrollment
measure: Alcohol withdrawal symptoms
timeFrame: up to 7 days post enrollment
measure: Daily naltrexone medication adherence
timeFrame: up to 7 days post enrollment
measure: Daily gabapentin medication adherence
timeFrame: up to 7 days post enrollment
measure: Treatment linkage
timeFrame: 7 days
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Kathryn Hawk, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: