Clinical TrialAlcohol Use Disorder (AUD)KetaminePlaceboWithdrawn

Ketamine for the Treatment for Alcohol Use Disorder in the ED

Pilot double-blind, placebo-controlled randomised clinical trial (n=50) testing a single IV ketamine infusion (0.8 mg/kg over 40 minutes) versus saline in adults with severe alcohol use disorder seeking inpatient detoxification in the ED to assess safety and preliminary efficacy.

Target Enrollment
50 participants
Study Type
Phase II interventional
Design
Randomized, triple Blind

Detailed Description

Randomised, triple-blind, parallel-group trial comparing a single IV ketamine infusion (0.8 mg/kg, 40 minutes) with saline placebo in individuals presenting to the ED for inpatient alcohol detoxification; primary aim is safety.

Secondary measures include alcohol use outcomes (TLFB abstinent days, days to relapse, heavy drinking days), engagement with addiction treatment, urine ketamine, and alcohol biomarkers at 28 days.

Study Protocol

Preparation

sessions

Dosing

1 sessions
40 min each

Integration

sessions

Study Arms & Interventions

Ketamine

experimental

Single IV ketamine infusion 0.8 mg/kg over 40 minutes (n=25).

Interventions

  • Ketamine0.8 mg/kg
    via IV• single dose• 1 doses total

    Infusion over 40 minutes in ED.

Placebo

inactive

Saline placebo 0.9% infusion over 40 minutes (n=25).

Interventions

  • Placebo
    via IV• single dose• 1 doses total

    0.9% saline infused over 40 minutes.

Participants

Ages
18 – 99
Sexes
Male & Female

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)

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 >130 bmp, 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

Study Details

Locations

Brigham and Women's Faulkner Hospital — Boston, Massachusetts, United States

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