Ketamine for the Treatment for Alcohol Use Disorder in the ED

• Status: Not yet recruiting
• Trial end date: 2024-08-30
• Target enrollment: 0
• Participant gender: All

Summary

The investigators' approach is to conduct a pilot double-blind, placebo-controlled randomized clinical trial with individuals with alcohol use disorder (AUD) seeking inpatient alcohol detoxification in the emergency department (ED) to receive either intravenous ketamine or saline placebo. The primary aim is to evaluate the intervention's safety. The secondary aim is to evaluate the preliminary efficacy of alcohol-related outcomes.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ketamine

Criteria

Inclusion Criteria:

• English speaking adults aged 18 and above

• Diagnosed with DSM5 alcohol use disorder, severe

• Admitted to BWF inpatient withdrawal management unit (Addiction Recovery Program)

• Able to identify 2 individuals who can act as points of contact following discharge from the hospital

Exclusion Criteria:

• Any psychotic disorder, bipolar disorder, active suicidality or homicidality

• Inability to perform consent due to impaired mental status

• Clinical Institute Withdrawal Assessment (CIWA) score > 20 at any point in the ED

• Alcohol withdrawal seizure prior to or during the ED visit

• Systolic blood pressure persistently elevated above 180mmHg, or heart rate >130bmp, in the ED

• History of hypersensitivity to ketamine, or experience of emergence reaction

• History of any illicit or recreational use of ketamine

• Receipt of ketamine treatment for depression in the past 3 months

• History of DSM5 hallucinogen use disorder, intracranial mass or bleed, porphyria, thyrotoxicosis, seizure disorder other than from alcohol withdrawal, liver cirrhosis, renal failure, obstructive lung disease, or sleep apnea

• History within 6 months of head trauma, stroke, or myocardial infarction

• Liver dysfunction with LFTs >3x upper normal limit

• Current use of medications with known drug-drug interactions with ketamine (i.e., St. John's Wort, theophylline, opioid analgesics, CNS depressants other than benzodiazepines or phenobarbital)

• Pregnant