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Clinical and Mechanistic Effects of Psilocybin in Alcohol Addicted Patients

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ClinicalTrials.gov Identifier: NCT04141501
Recruitment Status : Recruiting
First Posted : October 28, 2019
Last Update Posted : May 20, 2022
Schweizerischer Nationalfonds
Information provided by (Responsible Party):
University of Zurich

Brief Summary:
Effects of serotonin 2A/1A receptor stimulation by psilocybin on alcohol addicted patients: a randomized double-blind placebo-controlled study

Condition or disease Intervention/treatment Phase
Alcohol Use Disorder Drug: Psilocybin Drug: Placebo oral capsule Phase 2

Detailed Description:

Two billion people globally consume alcohol, leading in 2016 to 2.8 million deaths (5.2% of all deaths) and 99.2 million Disability Adjusted Life Years (DALYs) lost (4.2% of all DALYs). Of all the diseases, conditions, and injuries attributable to alcohol use, alcohol use disorders (AUDs) create the largest health burden globally. However, approved pharmacological treatments for alcoholism are limited in their effectiveness. A recent proof of- concept study testing psilocybin in ten alcohol dependent patients provides encouraging efficacy results and safety data. The investigators, therefore, propose to test the efficacy of psilocybin for treating alcohol use disorder and study its underlying neurobiological mechanisms in a randomized, placebo controlled, double blind study. To evaluate effects of psilocybin on alcohol use behaviour, clinical symptoms, neurocognitive and emotional measures in patients with alcohol use disorder.

The present clinical trial aims at investigation the clinical and mechanistic effects of Psilocybin in Alcohol Addicted Patients.

Patients with alcohol use disorder who have undergone withdrawal treatment within the last 6 weeks will be investigated in a single-centre, double-blind, placebo-controlled, parallel-group design clinical trial contrasting the acute and persisting effects of psilocybin to those of placebo. Patients will be randomly assigned to psilocybin or placebo group with a 1:1 allocation ratio. The study comprises a total of 6 visits during 6 weeks and two follow-up online surveys (3 and 6 months after treatment). In addition, two follow-up surveys that can be completed from home will guarantee monitoring of long-lasting changes in symptomology and ensure all potential side-effects can be captured. On the treatment visit, a single dose of psilocybin (25mg) or placebo will be administered. Patients will be monitored until all effects have worn off.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase II, randomized, double blind, placebo controlled, parallel group, single center study
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: double-blinded
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Double Blind, Placebo Controlled, Parallel Group, Single Center Study of Psilocybin Efficacy and Mechanism in Alcohol Use Disorder
Actual Study Start Date : June 8, 2020
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Arm Intervention/treatment
Placebo Comparator: Control: Placebo
30 Patients will receive placebo
Drug: Placebo oral capsule
single dose of mannitol (100%)

Active Comparator: Intervention: Psilocybin
30 Patients will receive psilocybin
Drug: Psilocybin
single dose of psilocybin (25mg). orally in form of a capsule

Primary Outcome Measures :
  1. Changes in Time-Line Follow-Back [ Time Frame: every day from baseline until 6 months after the intervention ]
    measures changes of the alcohol use behavior over time.The Time-Line Follow-Back questionnaire assesses the standard glasses of alcohol consumed in a day. The minimum is no alcohol consumption, with the maximum being an open end. Less alcohol consumption will be the better outcome, whereas more alcohol consumption will be a worse outcome. The Time-Line Follow-Back isn't a scale.

Secondary Outcome Measures :
  1. Brain [ Time Frame: five day before intervention until two weeks after intervention ]
    changes in functional connectivity during resting-state, changes in cue-reactivity, and autobiographic memory assessed with fMRI

  2. Empathy [ Time Frame: five day before intervention until two weeks after intervention ]
    Changes in empathy assessed with the Multifaceted Empathy Task

  3. Blood sample: Neural profile analysis [ Time Frame: five days before intervention ]
    To investigate the in vitro neuronal profile of psilocybin in alcohol dependent individuals blood cells before and after psilocybin administration will be differentiated into cortical neurons.

  4. Blood sample: Epigenetic analysis [ Time Frame: five day before intervention and two weeks after the intervention ]
    Genome-wide genetic analyses will be conducted to investigate association between gene variants and treatment outcomes. Genome-wide changes in epigenetic markers of treatment response will be analysed before and after psilocybin administration

  5. Blood sample: Markers of alcohol use [ Time Frame: will be analysed at screening visit and two weeks after the intervention ]
    Ethylglucuronid, aspartate aminotransferase (AST), alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) will be analysed from blood samples (except for Ethylglucuronid which will be analysed in urine samples) as objective markers of alcohol use. Additionally, cortisol will be analysed.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Informed Consent as documented by signature (Appendix Informed Consent Form)
  • Right-handedness
  • DSM-IV-diagnosis of alcohol use disorder (based on clinical assessment and confirmed by the SCID Interview)
  • Having undergone withdrawal treatment from alcohol use within 6 weeks prior to enrolment in the study
  • Drug free from any psychotropic and serotonergic medication for at least five days before administration of the study drug or placebo
  • No alcohol use between withdrawal treatment and administration of study drug or placebo
  • Good physical health with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology
  • Normal level of language comprehension (German or Swiss- German)
  • Willing to refrain from drinking caffeinated drinks during the testing days and from consuming psychoactive substances after enrolling in the study and for the remainder of the study
  • Women of childbearing potential must be using an effective, established method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices. Note: female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
  • Have a family member or friend who can pick them up and stay with them overnight after the psilocybin administration sessions (driving is forbidden at drug treatment days)
  • No further medication is allowed until visit 6, except for emergencies

Exclusion Criteria:

  • Allergy, hypersensitivity, or other adverse reaction to previous use of psilocybin or other hallucinogens
  • uncorrected Hypertension
  • Women who are pregnant or breast feeding
  • Intention to become pregnant during the course of the study,
  • Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases (Female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential)
  • Known or suspected non-compliance
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
  • Previous enrolment into the current study
  • Enrolment of the investigator, his/her family members, employees and other dependent persons
  • Lifetime history of bipolar disorder (I, II, not otherwise specified) Lifetime history of schizophrenia, schizoaffective disorder, or psychosis not otherwise specified
  • History of DSM-IV drug dependence other than alcohol (except for caffeine or nicotine) within two months prior to enrolment
  • Comorbid Axis I anxiety and depression disorders diagnoses as well as post-traumatic stress disorder will be permitted if they do not require current treatment
  • Family history of schizophrenia or schizoaffective disorder, or bipolar disorder type 1 (first or second degree relatives)
  • History of suicidal behaviour or violent behaviour within last 2 years
  • Lifetime history of hallucinogen use on more than 10 occasions within last 10 years
  • Getting psychotherapeutic or psychological treatment from third parties during the study is forbidden
  • Abnormal electrocardiogram
  • Any unstable illness as determined by history or laboratory tests
  • BMI <17 or >30
  • Uncorrected hypo- or hyperthyroidism
  • Contraindications to magnetic resonance imaging (MRI safety form)
  • During the study, new use or dose changes of already existing concomitant medication without prior informing the investigators is forbidden
  • High risk of adverse emotional or behavioural reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behaviour, serious current stressors, lack of meaningful social support)
  • Participation in another study with investigational drug within the 30 days preceding and during the present study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04141501

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Contact: Nathalie Rieser +41 44 384 33 24 studie133@bli.uzh.ch
Contact: Katrin Preller, PhD +41 44 384 25 26 preller@bli.uzh.ch

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Psychiatrische Universitätsklinik Zürich Recruiting
Zürich, Switzerland, 8032
Contact: Nathalie Rieser    +41 44 384 33 24    nathalie.rieser@bli.uzh.ch   
Contact: Katrin Preller, Phd    +41 44 384 25 26    preller@bli.uzh.ch   
Sponsors and Collaborators
University of Zurich
Schweizerischer Nationalfonds
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Principal Investigator: Katrin Preller, Dr. Psychiatric University Clinic
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Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT04141501    
Other Study ID Numbers: PsiAlc133
First Posted: October 28, 2019    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Zurich:
clinical efficacy
autobiographical memory
cue-reactivity exposure
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Physiological Effects of Drugs
Psychotropic Drugs