RECRUITING

Psilocybin vs Ketamine for Alcohol Use Disorder

Description

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.

Conditions

Alcohol Use DisorderAlcohol DependenceAlcohol Abuse
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Related Conditions:

Alcohol Use DisorderAlcohol DependenceAlcohol Abuse

Study Overview

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Study Details

Study 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.

Psilocybin vs Ketamine for Alcohol Use Disorder

Psilocybin vs Ketamine for Alcohol Use Disorder

Condition
Alcohol Use Disorder
Intervention / Treatment

-

Contacts and Locations

Iowa City

University of Iowa Health Care, Iowa City, Iowa, United States, 52240

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

  • * 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

Ages Eligible for Study

21 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Iowa,

Peggy C Nopoulos, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

2028-04