Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

Clairvoyant Therapeutics

Status and phase: Active, not recruiting; Phase 2

Conditions: Alcohol Use Disorder

Treatments: Drug: Psilocybin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05646303

CLA PSY 201

Details and patient eligibility

About

The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question[s] it aims to answer are:

• Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy?
• Is treatment with psilocybin and therapy safe for participants?

Participants will

• Attend 13 study visits
• Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo
• Record their daily alcohol consumption on study specific device

Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator.
• Expressed a wish to reduce or stop alcohol consumption.
• Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.

Exclusion criteria

• Diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic episode. Recent (within last 12 months) diagnosis of a major depressive disorder (MDD) (HAM-D score >19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder, or eating disorders.
• Subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session.
• History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups, including a placebo group

Psilocybin

Experimental group

Description:

2 oral doses of 25mg psilocybin capsules

Treatment:

Drug: Psilocybin

Placebo

Placebo Comparator group

Description:

2 oral doses of placebo (microcrystalline cellulose) capsules

Treatment:

Drug: Placebo