Psilocybin versus ketamine for reducing heavy drinking in alcohol use disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, active-comparator Phase 2 trial with two arms of 40 participants each comparing psilocybin (30 mg) versus ketamine (0.75 mg/kg) delivered alongside individual psychotherapy. Eligible participants are adults meeting DSM-5 criteria for moderate to severe alcohol use disorder who have had at least four heavy drinking days in the past 30 days and who meet medical and psychiatric inclusion/exclusion criteria. Key exclusions include recent hallucinogen or ketamine use, personal or family history of psychotic disorders, significant cardiac, neurologic, hepatic, or seizure disorders, pregnancy or breastfeeding, and ongoing formal AUD treatment. The study will collect clinical and behavioral measures of alcohol use and related outcomes over follow-up to compare the effects of the two interventions.

Why it matters

Who can join: the full rules

Inclusion 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

Exclusion Criteria:

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 disorder including cocaine, psychostimulant, or opioid use disorder within past 12 months 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), or pregnancy.

MRI contraindication (pacemaker, etc.)

Where it's running

• University of Iowa Health Care
  Iowa City, Iowa, United States Recruiting

Study contacts

• Principal investigator: Peggy C Nopoulos, MD — University of Iowa
• Study coordinator: Lindsay E Golden, BS
• Email: lindsay-golden@uiowa.edu
• Phone: 319-384-5243

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.