RECRUITING

Emergency Department-Initiated Medications for Alcohol Use Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Emergency Department-Initiated Medications for Alcohol Use Disorder

Quick Facts

Study Start:2024-08-17
Study Completion:2028-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05827159

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Between 18 and 80 years in age
  2. 2. Diagnosed with moderate to severe Alcohol Use Disorder
  3. 3. Stated willingness and ability to comply with all study procedures and availability for the duration of the study
  4. 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. 5. Able to speak English sufficiently to understand study procedures and provide written informed consent to participate in the study.
  6. 6. Clinical Alcohol Withdrawal Scale (CIWA-Ar) ≥ 4.
  1. 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. 2. Current prescription of opioid pain medications, or anticipated need for opioid pain medications during the study period (i.e. planned surgery)
  3. 3. History of complicated alcohol withdrawal
  4. 4. Condition that precludes interview (i.e., life threatening injury/illness)
  5. 5. Inability to consent due to cognitive impairment
  6. 6. Awaiting an acute psychiatric evaluation for psychosis or suicidal ideation
  7. 7. In police custody
  8. 8. Unable to provide contact information
  9. 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. 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. 11. Creatine Clearance \<60 mL/min within past 72 hours.
  12. 12. Currently pregnant or breast feeding
  13. 13. Requiring hospitalization at the time of the index visit
  14. 14. Past week treatment with medications for the treatment of alcohol use disorder
  15. 15. Taking gabapentin or naltrexone for any reason
  16. 16. Appearing unable or unwilling to comply with discharge instructions or complete follow-up
  17. 17. Current residence outside of the state of Connecticut

Contacts and Locations

Study Contact

Kathryn Hawk, MD, MHS
CONTACT
267-334-4415
Kathryn.hawk@yale.edu

Principal Investigator

Kathryn Hawk, MD, MHS
PRINCIPAL_INVESTIGATOR
Yale University

Study Locations (Sites)

Yale New Haven Hospital
New Haven, Connecticut, 06520
United States

Collaborators and Investigators

Sponsor: Yale University

  • Kathryn Hawk, MD, MHS, PRINCIPAL_INVESTIGATOR, Yale University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-17
Study Completion Date2028-03-01

Study Record Updates

Study Start Date2024-08-17
Study Completion Date2028-03-01

Terms related to this study

Keywords Provided by Researchers

  • Emergency Department
  • Brief Intervention
  • Naltrexone
  • Gabapentin

Additional Relevant MeSH Terms

  • Alcohol Use Disorder