RECRUITING

Psilocybin vs Ketamine for Alcohol Use Disorder

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Psilocybin vs Ketamine for Alcohol Use Disorder

Quick Facts

Study Start:2025-06-12
Study Completion:2028-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06405607

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.

Ages Eligible for Study:21 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Weight between 50kg and 150kg
  2. * No known allergies to rescue medication
  3. * For people capable of becoming pregnant, not pregnant and using contraception
  4. * Not currently breastfeeding
  5. * Meets criteria for DSM-V moderate to severe AUD.
  6. * Have at least 4 heavy drinking days (5 or more standard drinks in a day) in the past 30 days.
  7. * Not currently participating in formal treatment for AUD.
  8. * No history of a of cerebrovascular accident, asthma, or significant alcohol withdrawal history
  9. * No seizure disorder, coronary artery disease, heart failure, uncontrolled hypertension, insulin-dependent diabetes, pancreatitis, liver disease
  10. * No hallucinogen or ketamine use in past 12 months
  11. * No self-reported, personal, or familial history of specific psychotic disorders/episodes.
  12. * No serious traumatic brain injury (TBI) in the past 2 years
  13. * No substance use disorder other than AUD over the past 12 months
  14. * If taking a GLP-1 agonist, stable dosage for past 3 months
  15. * Family member/friend for pick-up, overnight post-drug session monitoring.
  16. * No MRI contraindications
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Lindsay E Golden, BS
CONTACT
319-384-5243
lindsay-golden@uiowa.edu
Peggy C Nopoulos, MD
CONTACT
319-356-1144
peggy-nopoulos@uiowa.edu

Principal Investigator

Peggy C Nopoulos, MD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Iowa

  • Peggy C Nopoulos, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-12
Study Completion Date2028-04

Study Record Updates

Study Start Date2025-06-12
Study Completion Date2028-04

Terms related to this study

Keywords Provided by Researchers

  • psychedelic
  • psilocybin
  • ketamine

Additional Relevant MeSH Terms

  • Alcohol Use Disorder
  • Alcohol Dependence
  • Alcohol Abuse