Ketamine for the Treatment for Alcohol Use Disorder in the ED

NCT05661669 | Withdrawn Phase 2 DMC FDA Drug

• 2 other identifiers: 2022P0025501R21AA030372-01A1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Safety of administering ketamine in the emergency department (ED) for alcohol use disorder (AUD) patients seeking detoxification

  The incidence of severe adverse events (AE), defined as either hypertensive urgency (systolic blood pressure\>180mmHg or diastolic blood pressure\>110mmHg) or tachycardia (heart rate\>130bpm). Adequate safety will be defined as \<10% of participants experiencing severe AEs.

  Outcomes will be assessed throughout the inpatient admission, on average 3-5 days and throughout duration of study.

Secondary Outcomes (18)

• Dissociative effects

  Baseline, daily during inpatient (average 3-5 days), 28 days, and 3, 6, and 12 months after inpatient treatment.

• Alcohol withdrawal

  Assessed during the inpatient admission, on average 3-5 days.

• Craving for alcohol

  Assessed during the inpatient admission, on average 3-5 days; 7, 14, 28 days and 3, 6, and 12 months after treatment

• Craving for ketamine

  Assessed during the inpatient admission, on average 3-5 days; 7, 14, 28 days and 3, 6, and 12 months after treatment

• Cue-induced craving

  Assessed during the inpatient admission, on average 3-5 days; 28 days after treatment

Study Arms (2)

Ketamine

EXPERIMENTAL

This arm will receive ketamine (n=25)

Drug: Ketamine

Placebo

PLACEBO COMPARATOR

This arm will receive the saline placebo (n=25)

Drug: Saline

Interventions

Ketamine DRUG

The intervention will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes.

Ketamine

Saline DRUG

The placebo will be a 0.9% saline solution administered over 40 minutes.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking adults aged 18 and above
• Diagnosed with DSM5 alcohol use disorder, severe
• Admitted to BWF inpatient withdrawal management unit (Addiction Recovery Program)

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Addiction Psychiatry

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 22, 2022
• Study Start: September 1, 2023
• Primary Completion: August 19, 2024
• Study Completion: August 19, 2024
• Last Updated: January 8, 2025

Record last verified: 2025-01

Locations

US (1)