Actively Recruiting
Psilocybin or Ketamine for Alcohol Use Disorder: An Active Comparator Trial
Led by University of Iowa · Updated on 2025-11-28
80
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 alcohol use disorder
- 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 alcohol use disorder
- 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, or 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 alcohol use disorder over the past 12 months
- If taking a GLP-1 agonist, stable dosage for past 3 months
- Have a 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 medications, nutritional supplements, or herbal supplements not approved by the study investigators
- Being medically unstable
- Current use of medications that may interact with the study drugs, including antidepressants, antipsychotics, psychostimulants, treatments for addictions, dopaminergic or serotonergic agents, lithium, anticonvulsants, or benzodiazepines
- History of severe suicide attempt or current suicidality
- First-degree relative with schizophrenia or schizoaffective disorder
- Comorbid substance use disorder including cocaine, psychostimulant, or opioid use disorder within the past 12 months
- History of co-occurring psychotic episode or diagnosis such as schizophrenia, schizoaffective disorder, schizophreniform, substance-induced psychosis, delusional disorder, or unspecified psychosis
- High risk of adverse emotional or behavioral reaction based on medical monitor evaluation including serious stressors, lack of social support, antisocial behavior, or serious personality disorders
- Serious ECG abnormalities such as ischemia, myocardial infarction, or prolonged QTc
- Serious abnormalities in blood counts or chemistries
- Medical conditions precluding safe participation, including significantly impaired liver function
- Pregnancy
- MRI contraindications such as having a pacemaker
AI-Screening
AI-Powered Screening
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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
CONTACT
P
Peggy C Nopoulos, MD
CONTACT
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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