NCT05827159 Emergency Department-Initiated Medications for Alcohol Use Disorder
| NCT ID | NCT05827159 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Yale University |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 240 participants |
| Start Date | 2024-08-17 |
| Primary Completion | 2028-08-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 240 participants in total. It began in 2024-08-17 with a primary completion date of 2028-08-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Kathryn Hawk, MD, MHS
PRINCIPAL INVESTIGATOR
Yale University
Frequently Asked Questions
Who can join the NCT05827159 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Alcohol Use Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05827159 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 240 participants.
Is NCT05827159 currently recruiting?
Yes, NCT05827159 is actively recruiting participants. Contact the research team at Kathryn.hawk@yale.edu for enrollment information.
Where is the NCT05827159 trial being conducted?
This trial is being conducted at New Haven, United States.
Who is sponsoring the NCT05827159 clinical trial?
NCT05827159 is sponsored by Yale University. The principal investigator is Kathryn Hawk, MD, MHS at Yale University. The trial plans to enroll 240 participants.