A Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted Psychotherapy in Adults with Alcohol Use Disorder (AUD)
- Conditions
- Alcohol use disorder (AUD)Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]MedDRA version: 20.1Level: PTClassification code 10080021Term: Alcohol use disorderSystem Organ Class: 10037175 - Psychiatric disorders
- Registration Number
- EUCTR2021-006200-33-FI
- Lead Sponsor
- Clairvoyant Therapeutics Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 160
• 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.
• A subject is eligible for participation in the trial if he/she/they (sex at birth) had:
a. =6 HDDs (defined as a day with alcohol consumption of 60 g or more for males and 40 g or more for females) in a 4-week period prior to V1 (TLFB) OR an average alcohol consumption of >40 g of ethanol/day for males and >20 g of alcohol/day for females for a 4-week period prior to V1 (TLFB), [minimum of the medium risk level as defined by the WHO International therapist for monitoring alcohol consumption and related harm.]
AND
b. =6 HDDs (defined as a day with alcohol consumption of 60 g or more for males and 40 g or more for females) in a 4-week period prior to V5 (e-diary),
• Expressed a wish to reduce or stop alcohol consumption.
• Able to provide alcohol consumption information for the 4-week period prior to V1.
• Willingness to participate in behavioural and medicinal treatments for AUD.
• Subjects of childbearing potential must be using a highly effective, established method of contraception for the entire trial duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices.
Note: Subjects identified female-at-birth who are surgically sterilised (bilateral salpingectomy, or bilateral oophorectomy)/hysterectomised at least 3 months before V1 or post-menopausal for longer than 2 years are not considered as being of childbearing potential.
Male subjects who engage in sex that could result in pregnancy should use condom with spermicide throughout their trial participation in addition to the use of a highly effective contraceptive method by any partner of childbearing potential.
• Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
• Withdrawal symptoms requiring additional medication defined as a score higher than 8 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
• 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 disorder. Recent (within last 12 months) diagnosis of a major depressive episode (MDD) (as according to Hamilton Depression Scale, HAM-D, score >19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder or eating disorders.
Note: Subjects with nicotine use disorder, phobic, or other anxiety disorders (other than post-traumatic stress disorder or panic disorder) can be included.
• Current or recent (within 6 weeks prior to V1) treatment with antipsychotic or antidepressant medications, which can influence serotonin receptor or transporter actions.
• History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses.
• Currently participating or has recently (4 weeks prior to V1) participated in a treatment program for AUD.
• Clinically significant untreated or unstable illness as defined by
a. Hepatic function:
• Aspartate aminotransferase (AST) >3x the upper limit of normal (ULN) or
•Alanine aminotransferase (ALT) >3x the upper limit of normal (ULN) or
• Total bilirubin >2x ULN
• Prolonged prothrombin time (PTT) INR =1.7
b. Renal function:
• Reduced estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2.
c. Cardiovascular functions:
• History or current evidence of a clinically significant cardiovascular disease, including myocardial infarction, cerebrovascular accident, unstable angina, New York Heart Association Class II or greater heart failure, severe cardiac arrhythmia requiring medication or implanted defibrillator or pacemaker, syncope.
•Uncontrolled hypertension, defined by systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg (measured while subject is lying supine over a 5-minute duration. If necessary, these assessments will involve three readings separated by 5 minutes) with or without antihypertensive medications; or clinically significant hypotension.
• Finding of any of the following on the V1 ECG: QT interval corrected using Fridericia’s formula (QTcF) >450 msec (males) and >470 msec (females), frequent supraventricular or ventricular ectopy, complete right and left bundle branch block (QRS >110 ms), or any other ECG findings that, in the opinion of the Investigator is regarded as abnormal.
• Allergy, hypersensitivity, or other adverse reaction to previous use of psilocybin, other hallucinogens, rescue medications and their excipients or microcrystalline cellulose.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method