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NCT05661669
Ketamine for the Treatment for Alcohol Use Disorder in the ED
Conditions: Alcohol Use Disorder
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 50
Sponsor: Brigham and Women's Hospital
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.
Eligibility Criteria
Inclusion Criteria:English speaking adults aged 18 and aboveDiagnosed with DSM5 alcohol use disorder, severeAdmitted 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 hospitalExclusion Criteria:Any psychotic disorder, bipolar disorder, active suicidality or homicidalityInability to perform consent due to impaired mental statusClinical Institute Withdrawal Assessment (CIWA) score > 20 at any point in the EDAlcohol withdrawal seizure prior to or during the ED visitSystolic blood pressure persistently elevated above 180mmHg, or heart rate >130bmp, in the EDHistory of hypersensitivity to ketamine, or experience of emergence reactionHistory of any illicit or recreational use of ketamineReceipt of ketamine treatment for depression in the past 3 monthsHistory 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 apneaHistory within 6 months of head trauma, stroke, or myocardial infarctionLiver dysfunction with LFTs >3x upper normal limitCurrent 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
Source: ClinicalTrials.gov (NCT05661669). StuddyBuddy aggregates publicly available trial information.