Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial (NCT06405607) | Clinical Trial Compass
RecruitingPhase 2
Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
United States80 participantsStarted 2025-06-12
Plain-language summary
This study will collect data that measures the effects of a psychedelic intervention on patients struggling with alcohol use disorder (AUD). The study design will be a double blind, randomized, active-comparator trial with two study arms. Subjects randomized to Arm 1 (n=40) will receive individual psychotherapy sessions plus a 30 mg dose of psilocybin. Arm 2 subjects (n=40) will receive individual psychotherapy sessions and a 0.75 mg/kg dose of ketamine.
Who can participate
Age range21 Years – 65 Years
SexALL
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Inclusion criteria:
* Weight between 50kg and 150kg
* No known allergies to rescue medication
* For people capable of becoming pregnant, not pregnant and using contraception
* Not currently breastfeeding
* Meets criteria for DSM-V moderate to severe AUD.
* Have at least 4 heavy drinking days (5 or more standard drinks in a day) in the past 30 days.
* Not currently participating in formal treatment for AUD.
* No history of a of cerebrovascular accident, asthma, or significant alcohol withdrawal history
* No seizure disorder, coronary artery disease, heart failure, uncontrolled hypertension, insulin-dependent diabetes, pancreatitis, liver disease
* No hallucinogen or ketamine use in past 12 months
* No self-reported, personal, or familial history of specific psychotic disorders/episodes.
* No serious traumatic brain injury (TBI) in the past 2 years
* No substance use disorder other than AUD over the past 12 months
* If taking a GLP-1 agonist, stable dosage for past 3 months
* Family member/friend for pick-up, overnight post-drug session monitoring.
* No MRI contraindications
Exclusion Criteria:
Drug/medication assessment that yields: nonprescription medication use, nutritional supplement, or herbal supplement (except when approved by the study investigators), medically unstable, current medication use that has significant potential to interact with study drug (e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonerg…