Status:
UNKNOWN
Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder
Lead Sponsor:
Anders Fink-Jensen, MD, DMSci
Collaborating Sponsors:
The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief Summary
Note: The trial is only eligible for citizens of Denmark. The purpose of this project is to assess the treatment efficacy of a single high dose of psilocybin administered within a protocol of psychol...
Detailed Description
To establish efficacy, we will investigate a single dose of psilocybin versus placebo in a randomised, double-blinded, placebo-controlled 12 weeks clinical trial. 90 patients, aged 20-70 years, diagno...
Eligibility Criteria
Inclusion
- Bodyweight of 50-110 kg
- AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
- AUD Identification Test (AUDIT) ≥ 15.
- ≥ 5 heavy drinking days in the past 28 days prior to inclusion.
Exclusion
- Current or previously diagnosed with any psychotic disorder or bipolar affective disorder.
- Immediate family member with a diagnosed psychotic disorder.
- History of delirium tremens or alcohol withdrawal seizures.
- History of suicide attempt or present suicidal ideation at screening.
- Withdrawal symptoms at screening (\>nine on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (43).
- Present or former severe neurological disease including trauma with loss of consciousness \> 30 min.
- Impaired hepatic function (alanine transaminase \>210/135 units/l men/women)
- Cardiovascular disease defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, myocardial infarction within the last 12 months or uncontrolled hypertension (systolic blood pressure \>165 mmHg, diastolic blood pressure \>95 mmHg).
- Present or former abnormal QTc (\>450/470 ms men/women).
- Treatment with disulfiram, naltrexone, acamprosate and nalmefene within 28 days of inclusion.
- Treatment with any serotonergic medication or drugs within one month prior inclusion.
- Any oOther active substance use disorders (except nicotine) defined as a Drug Use Disorder Identification Test score \>six/two (men/women) and investigator's clinical evaluation.
- Women who are pregnant, breastfeeding, or intend to become pregnant or are not using adequate contraceptive measures considered highly effective (44).
- Unable to speak or understand Danish.
- Any other condition that the clinician estimates can interfere with trial participation.
Key Trial Info
Start Date :
September 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT05416229
Start Date
September 1 2023
End Date
November 1 2025
Last Update
August 24 2023
Active Locations (1)
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1
Psychiatric Center Copenhagen, Frederiksberg Hospital
Frederiksberg, Denmark, 2000