Ketamine for the Treatment for Alcohol Use Disorder in the ED

NCT ID: NCT05661669

Last Updated: 2025-01-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-08-19

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.

Detailed Description

This is a pilot double-blind, placebo-controlled randomized clinical trial of 50 individuals with alcohol use disorder (AUD) presenting to the emergency department (ED) seeking inpatient detoxification to receive either a single infusion of ketamine 0.8mg/kg (n=25) or saline placebo (n=25). The study will be conducted at Brigham and Women's Faulkner Hospital (BWF), an urban, 171-bed hospital located in Boston, MA, and a major teaching hospital for Harvard Medical School (HMS). Participants will be randomized in a double-blind fashion to receive either ketamine or saline placebo in the ED. All participants will receive the institution's standard treatment, which includes detoxification, intensive psychosocial support, and referral to outpatient treatment. The intervention (ketamine) will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes, and the placebo will be a 0.9% saline solution also administered over 40 minutes. To determine the safety of administering ketamine the investigators will measure 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). The investigators will also assess side effects, alcohol withdrawal, and craving for alcohol and ketamine. To determine the preliminary efficacy of ketamine on alcohol-related outcomes, the investigators will measure the proportion of abstinent days during the follow-up assessed using Timeline Follow-Back (TLFB). The investigators will also measure days to relapse, the proportion of heavy drinking days, engagement with addiction treatment, urine ketamine, and alcohol biomarkers (urine ethylglucuronide and serum phosphatidylethanol) at 28-days. The investigators hypothesize that results will show adequate safety and that those receiving ketamine, compared to placebo, will not experience more side effects, worse withdrawal, or greater alcohol or ketamine craving. The investigators also hypothesize that those receiving ketamine will report better drinking outcomes compared to placebo.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ketamine

This arm will receive ketamine (n=25)

Group Type: EXPERIMENTAL

Ketamine

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

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

Interventions

Ketamine

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

Intervention Type: DRUG

Saline

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

Intervention Type: DRUG

Eligibility 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)

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joji Suzuki, MD

Director, Division of Addiction Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

1R21AA030372-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2022P002550

Identifier Type: -

Identifier Source: org_study_id