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Recruiting NCT06405607

Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial

Phase II Interventional Alcohol Use Disorder Alcohol Dependence Alcohol Abuse

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Psilocybin, Ketamine.
Who it may be relevant to
Registry conditions: Alcohol Use Disorder, Alcohol Dependence, Alcohol Abuse. Basic parameters: 21 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Psilocybin vs Ketamine for Alcohol Use Disorder

Overview

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.

Interventions

  • Drug Psilocybin
    30 mg single dose
  • Drug Ketamine
    0.75 mg/kg weight-based single dose

Primary outcome measures

  • Timeline Follow-Back for Alcohol to assess change [Time frame: Weekly, over the course of 16 weeks]
Secondary outcome measures (3)
  • T1rho [Time frame: Twice (before intervention, post intervention): at week 1 and week 16]
  • Resting state fMRI [Time frame: Twice (before intervention, post intervention):: at week 1 and week 16]
  • EEG- signal complexity [Time frame: Twice (before drug administration and at peak of drug experience) during week 3]

Eligibility 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

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.)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Iowa Health Care — Iowa City

Identifiers

NCT: NCT06405607 · 202404714

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗