A Phase 2 interventional study of Ketamine and Saline in Alcohol Use Disorder, sponsored by Brigham and Women's Hospital. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-08.
Sponsored by Brigham and Women's Hospital · Phase 2, Interventional, and Treatment
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.
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.
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Exclusion Criteria:
This arm will receive ketamine (n=25)
Drug: Ketamine
This arm will receive the saline placebo (n=25)
Drug: Saline
The intervention will consist of a single infusion of ketamine in the ED at a dose of 0.8mg/kg over 40 minutes.
The placebo will be a 0.9% saline solution administered over 40 minutes.
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.
Time frame: Outcomes will be assessed throughout the inpatient admission, on average 3-5 days and throughout duration of study.
Dissociative effects
Clinician-Administered Dissociative States Scale (CADSS)
Time frame: Baseline, daily during inpatient (average 3-5 days), 28 days, and 3, 6, and 12 months after inpatient treatment.
Alcohol withdrawal
Clinical Institute Withdrawal Assessment (CIWA)
Time frame: Assessed during the inpatient admission, on average 3-5 days.
Craving for alcohol
Alcohol craving questionnaire
Time frame: 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
Visual analog scale
Time frame: 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
Visual analog scale will be used to rate the craving following a standardized protocol used to assess cue reactivity. The cue exposure procedure will end with a standardized relaxation exercise.
Time frame: Assessed during the inpatient admission, on average 3-5 days; 28 days after treatment
Preliminary efficacy of ketamine on days to alcohol relapse
Days to relapse will be measured by using the Timeline Follow-Back (TLFB).
Time frame: 7, 14, 28 days and 3, 6, and 12 months after treatment
Preliminary efficacy of ketamine on proportion heavy drinking days
The proportion of heavy drinking days will be measured by using the Timeline Follow-Back (TLFB).
Time frame: 7, 14, 28 days and 3, 6, and 12 months after treatment
Preliminary efficacy of ketamine on engagement with addiction treatment
The Alcoholic Anonymous Affiliation Scale (AAAS) will be used to measure engagement with addiction treatment. This is a 9-item scale to measure the degree of involvement with Alcoholics Anonymous.
Time frame: Measured at baseline, 28 days, and 3, 6, and 12 months post treatment.
Ketamine in Urine
Urine drug screen that includes ketamine will be assessed.
Time frame: At baseline and 28 days after treatment
Urine ethylglucuronide
Urine ethylglucuronide (EtG) will be obtained
Time frame: At baseline and at 28 days after treatment
Phosphatidylethanol (PEth)
Serum phosphatidylethanol (PEth)
Time frame: At baseline and at 28 days after treatment
Behavior Change Mechanisms
Mechanisms of behavior change will be measured using tools from the Science of Behavior Change Measures.
Time frame: Once during inpatient treatment and at 28 days after treatment
Anxiety
We will assess anxiety levels utilizing a 7-item scale (Generalized Anxiety Disorder - 7 (GAD-7))
Time frame: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Depression
We will assess depression levels utilizing a 9-item scale (Patient Health Questionnaire-9 (PHQ-9))
Time frame: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Suicidal Ideation
Columbia Suicide Severity Rating Scale (C-SSRS) will be used to assess suicidal Ideation
Time frame: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Post Traumatic Stress
A patient self-report tool developed to examine PTSD symptoms in general medical settings (Abbreviated PTSD Checklist - Civilian Version)
Time frame: Once during treatment
Study Drug Side Effects
We will use Patient Rated Inventory of Side Effects (PRISE) to qualify side effects in the following domains: gastrointestinal, heart, skin, nervous system, eyes/ears, genital/urinary, sleep, sexual functioning, and other. Each domain has multiple symptoms which can be endorsed. For each domain the patient rates whether the symptoms are tolerable or distressing.
Time frame: At baseline, each day during treatment (3-5 Days on average), 7, 14, 28 days and 3, 6, and 12 months after treatment
Spirituality
We will use a 23-item measure to assess spirituality (Spirituality Scale).
Time frame: Baseline, once during treatment, and at 28 days post treatment.
This study is withdrawn, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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