Clinical and Mechanistic Effects of Psilocybin in... — Clinical Trial Details

Participants

Ages

18 – 60

Sexes

Male & Female

BMI

17 - 30

Psychosis History

Excluded

Inclusion Criteria

Informed Consent as documented by signature
Right-handedness according to Oldfield (1971) performed during the telephone screening, laterality index ≥ 0.2
DSM-IV-diagnosis of alcohol use disorder (based on clinical assessment and confirmed by the SCID Interview)
Having undergone withdrawal treatment from alcohol use or have stopped consuming alcohol 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
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 (screening: >139 systolic or >89 diastolic)
Women who are pregnant or breast feeding or intend to become pregnant during the study
Lack of safe contraception for women of childbearing potential
Known or suspected non-compliance
Inability to follow study procedures (e.g., due to language problems, psychological disorders, dementia)
Previous enrolment into the current study
Enrolment of the investigator, family members, employees or dependent persons
Lifetime history of bipolar disorder (I, II, NOS), lifetime history of schizophrenia, schizoaffective disorder, or psychosis NOS
History of DSM-IV drug dependence other than alcohol (except caffeine or nicotine) within two months prior to enrolment
Comorbid Axis I anxiety and depression disorders and PTSD permitted only if they do not require current treatment
Family history of schizophrenia or schizoaffective disorder, or bipolar disorder type 1 (first or second degree relatives)
Violent behaviour within last 2 years or history of suicidal behaviour
Lifetime history of hallucinogen use on more than 10 occasions within last 10 years
Receiving 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 MRI
New use or dose changes of concomitant medication without informing investigators
Participation in another investigational drug study within 30 days prior to enrolment
Taking medications known to modulate UGT enzymes; inhibitors of UGT1A9/1A10 should be discontinued ≥5 half-lives prior to dosing
Monoamine oxidase and aldehyde or alcohol dehydrogenase inhibitors should be discontinued ≥5 half-lives prior to dosing

Company

Product

Legal

Clinical and Mechanistic Effects of Psilocybin in Alcohol Addicted Patients

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Related Publications

Psilocybin-assisted therapy for relapse prevention in alcohol use disorder: a phase 2 randomized clinical trial

Integration

Study Arms & Interventions

Psilocybin 25 mg

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details

Study Team

Sponsors & Collaborators