Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT05661669
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05661669
Study Brief:
Protocol Section:
NCT05661669