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

Launched by CLAIRVOYANT THERAPEUTICS · Dec 2, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how well psilocybin, a compound found in certain mushrooms, combined with therapy, can help adults who struggle with Alcohol Use Disorder (AUD). The main goals are to find out if this treatment can help reduce drinking more effectively than a placebo (a dummy treatment) along with therapy, and to ensure that it is safe for participants. People who take part in this study will attend 13 visits, participate in therapy sessions, and have two treatment sessions where they will either receive psilocybin or a placebo. Throughout the trial, they will keep track of their daily alcohol consumption.

To be eligible for this trial, participants should have a moderate to severe alcohol use problem and want to cut back or stop drinking. They need to be generally healthy and pass certain health checks. However, those with specific psychiatric disorders or a history of hallucinogen use disorder will not be allowed to participate. This trial is currently active but not recruiting new participants, and it welcomes individuals aged 18 to 65, regardless of gender. If you or a loved one is interested in the study or wants to learn more, it’s best to consult a healthcare professional.

Gender

ALL

Eligibility criteria

• 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.