Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder

Description

This pilot study will collect preliminary data that measures the effects of psilocybin-assisted psychotherapy vs ketamine-assisted psychotherapy on patients struggling with alcohol use.

Conditions

Alcohol Use Disorder

Study Overview

Study Details

Study overview

This pilot study will collect preliminary data that measures the effects of psilocybin-assisted psychotherapy vs ketamine-assisted psychotherapy on patients struggling with alcohol use.

Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder

Psilocybin-Assisted vs Ketamine-Assisted Psychotherapy for Alcohol Use Disorder

Condition
Alcohol Use Disorder
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa, Iowa City, Iowa, United States, 52242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male
  • * English fluency
  • * Meets criteria for DSM-V moderate to severe Alcohol Use Disorder (AUD)
  • * Have at least 4 heavy drinking days in the past 30 days
  • * Not currently participating in formal treatment for alcohol dependence
  • * 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
  • * At least a high-school level of education or equivalent (e.g. GED)
  • * Family member/friend for pick-up, overnight post-drug session monitoring
  • * Psilocybin and ketamine naïve
  • * No self-reported, personal, or familial history of specific psychotic disorders/episodes
  • * No serious traumatic brain injury (TBI) in the past 2 years
  • * No known allergies to diazepam (rescue medication)
  • * Weight between 50kg and 150 kg
  • * 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 including cocaine, psychostimulant, or opioid use disorder within past 12 months and/or any use within past 30 days, 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).
  • * MRI contraindication (pacemaker, etc.)

Ages Eligible for Study

25 Years to 50 Years

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Peggy C Nopoulos,

Peggy C Nopoulos, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

2025-02