Psilocybin vs Ketamine for Alcohol Use Disorder... — Clinical Trial Details

Parallel-group, double-blind randomised trial enrolling 80 participants with moderate–severe alcohol use disorder to compare efficacy and safety of a single 30 mg psilocybin session versus a single weight-based ketamine session (0.75 mg/kg), both delivered alongside individual psychotherapy.

Outcomes include alcohol consumption patterns (heavy drinking days), safety, and psychiatric measures; eligibility excludes recent hallucinogen/ketamine use, active suicidality, unstable medical conditions, and first-degree family history of psychotic disorders.

Participants

Ages

21 – 65

Sexes

Male & Female

BMI

Psychosis History

Excluded

Inclusion Criteria

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

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 serotonergic agents, lithium, anticonvulsants, or benzodiazepines).
Psychiatric assessment that yields: 1) history of severe suicide attempt, 2) current suicidality 3) first-degree relative with schizophrenia or schizoaffective disorder, 4) comorbid substance use disorder including cocaine, psychostimulant, or opioid use disorder within past 12 months 5) history of co-occurring psychotic episode/diagnosis including schizophrenia, schizoaffective disorder, schizophreniform, substance-induced psychosis, delusional disorder, or psychosis not otherwise specified, 6) high risk of adverse emotional or behavioral reaction based on the medical monitor's clinical evaluation that may also yield evidence of serious current stressors, a lack of meaningful social support, antisocial behavior, and/or serious personality disorders amongst other conditions.
Medical assessment that yields: serious ECG abnormalities (evidence of ischemia, myocardial infarction, QTc prolongation [QTc > .045]), serious abnormalities of complete blood count or chemistries, medical conditions that would preclude safe participation (significantly impaired liver function), or pregnancy.
MRI contraindication (pacemaker, etc.)

Company

Product

Legal

Psilocybin vs Ketamine for Alcohol Use Disorder (Psi vs Ket)

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Therapeutic Protocol

Study Arms & Interventions

Psilocybin

Interventions

Ketamine

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators