Actively Recruiting
Psilocybin vs Ketamine for Alcohol Use Disorder
Led by University of Iowa · Updated on 2025-11-28
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a psychedelic intervention on adults with moderate to severe alcohol use disorder (AUD). This is a phase 2, double-blind, randomized trial comparing two treatments combined with individual psychotherapy. The study aims to measure changes in alcohol consumption and brain activity in people struggling with AUD. The trial is sponsored by the University of Iowa and includes adults aged 21 to 65 with specific health and drinking history criteria. Participants are randomly assigned to one of two groups. One group receives individual psychotherapy plus a single 30 mg dose of psilocybin, while the other group receives individual psychotherapy plus a single dose of ketamine based on body weight (0.75 mg/kg). Both treatments are given once, and therapy sessions support the intervention. The trial lasts 16 weeks, with assessments at multiple time points. During the study, participants undergo regular evaluations including weekly alcohol use tracking with the Timeline Follow-Back method over 16 weeks. Brain imaging with resting state fMRI and T1rho scans occurs twice, before and after the intervention. EEG is recorded during the drug experience to assess brain signal complexity. Safety monitoring includes overnight observation after drug sessions, and participants must have a support person for post-treatment care. The study concludes with outcome measurements at 16 weeks to assess treatment effects.
CONDITIONS
Brief Title
Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 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 or episodes
- No serious traumatic brain injury 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 or friend available for pick-up and overnight post-drug session monitoring
- No MRI contraindications
You will not qualify if you...
- Use of nonprescription medication, nutritional or herbal supplements (unless approved by investigators)
- Medically unstable condition
- Current use of medications likely to interact with study drugs (e.g., antidepressants, antipsychotics, psychostimulants, addiction treatments, dopaminergic or serotonergic agents, lithium, anticonvulsants, benzodiazepines)
- History of severe suicide attempt or current suicidality
- First-degree relative with schizophrenia or schizoaffective disorder
- Comorbid substance use disorder including cocaine, psychostimulants, or opioids within past 12 months
- History of psychotic episodes or diagnoses including schizophrenia, schizoaffective disorder, schizophreniform, substance-induced psychosis, delusional disorder, or unspecified psychosis
- High risk of adverse emotional or behavioral reaction based on clinical evaluation
- Serious ECG abnormalities (ischemia, myocardial infarction, QTc prolongation)
- Serious abnormalities in blood counts or chemistry
- Medical conditions preventing safe participation (e.g., impaired liver function)
- Pregnancy
- MRI contraindications such as pacemaker or other implants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single session during Week 3
Participants receive individual psychotherapy sessions plus a single dose of either psilocybin (30 mg) or ketamine (0.75 mg/kg).
1 treatment visit and associated monitoring
Duration - 16 weeks
Participants are monitored weekly to assess changes in alcohol use and undergo assessments including T1rho MRI, resting state fMRI, and EEG signal complexity.
Weekly visits for assessments with 2 MRI visits (Week 1 and Week 16) and EEG assessments during Week 3
Trial Site Locations
Total: 1 location
1
University of Iowa Health Care
Iowa City, Iowa, United States, 52240
Actively Recruiting
Research Team
L
Lindsay E Golden, BS
P
Peggy C Nopoulos, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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