Psilocybin Therapy for Alcoholism

Recruiting in Palo Alto (17 mi)

+13 other locations

Overseen byHannu Alho, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Clairvoyant Therapeutics

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing whether psilocybin, a substance from certain mushrooms, combined with therapy can help people who drink too much alcohol. Psilocybin has shown promise in reducing heavy drinking days in previous trials for alcohol use disorder. The study will see if this combination works better than therapy alone. Participants will attend therapy sessions and take either psilocybin or another substance to see if their drinking decreases.

Eligibility Criteria

This trial is for adults with a moderate to severe Alcohol Use Disorder (AUD) who want to cut down or stop drinking. They must be generally healthy, without unstable medical conditions, and have no history of hallucinogen use disorder or significant psychiatric disorders like schizophrenia or bipolar disorder.

Inclusion Criteria

I want to cut down or quit drinking alcohol.

Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology

Moderate to severe diagnosis of AUD as measured by DSM-5 criteria using Structured Clinical Interview for DSM-5 by the investigator

Exclusion Criteria

History of hallucinogen use disorder, any use in the past 1 year, or more than 25 lifetime uses

I was diagnosed with a severe mood or anxiety disorder or an eating disorder in the last year.

I or someone in my family has been diagnosed with schizophrenia, bipolar disorder, OCD, or experienced a psychotic episode.

+1 more

Participant Groups

The study tests if psilocybin-assisted psychotherapy can help reduce alcohol consumption more effectively than placebo-assisted therapy. Participants will attend 13 visits, undergo therapy sessions including two where they'll receive either psilocybin or a placebo, and track their daily alcohol intake.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: PsilocybinExperimental Treatment1 Intervention

2 oral doses of 25mg psilocybin capsules

Group II: PlaceboPlacebo Group1 Intervention

2 oral doses of placebo (microcrystalline cellulose) capsules