Clinical and Mechanistic Effects of Psilocybin in Alcohol Addicted Patients

NCT04141501 | Completed Phase 2 DMC

• 1 other identifier: PsiAlc133
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Use Disorder

Keywords

Alcoholism; Psilocybin; Psychedelics; clinical efficacy; autobiographical memory; cue-reactivity exposure; placebo-controlled; proof-of-concept

Outcome Measures

Primary Outcomes (2)

• Changes in Time-Line Follow-Back

  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 primary efficacy value will be alcohol use (average of daily standard units of alcohol use between visit 3 and visit 6) between psilocybin administration and visit 6 (four weeks after psilocybin administration)

  every day from baseline until 6 months after the intervention (primary endpoint: 4 weeks after administration, follow-up period 6 months)

• Relapse using Time-Line Follow-Back

  Re-instatement of alcohol drinking behaviour \> 1 standard drink will be defined as relapse.

  Relapse will be compared between the placebo and psilocybin group in the time period four weeks after visit 3

Secondary Outcomes (23)

• Brain

  The MRI will be completed at baseline (visit 2, approx. 5 days prior), approx. 90 minutes after the administration of the investigational medicinal product (IMP), and following IMP-administration (approx. 4 weeks later).

• Empathy

  five days before IMP-administration, one day post and approx. 4 weeks post intervention

• Blood sample: Neural profile analysis

  At baseline, approx. five days before intervention

• Blood sample: Epigenetic analysis

  At baseline (approx. five day before intervention), one day after the IMP-administration, and approx. 4 weeks after the IMP-administration

• Blood sample: Markers of alcohol use

  This will be analysed at screening visit and approx. 4 weeks after the IMP-administration.

Study Arms (2)

Control: Placebo

PLACEBO COMPARATOR

30 Patients will receive placebo

Drug: Placebo oral capsule

Intervention: Psilocybin

ACTIVE COMPARATOR

30 Patients will receive psilocybin

Drug: Psilocybin

Interventions

Psilocybin DRUG

single dose of psilocybin (25mg). orally in form of a capsule

Intervention: Psilocybin

Placebo oral capsule DRUG

single dose of mannitol (100%)

Control: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Informed Consent as documented by signature
• Right-handedness according to Oldfield (1971) perfomed 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, 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

You may not qualify if:

• Allergy, hypersensitivity, or other adverse reaction to previous use of psilocybin or other hallucinogens
• uncorrected Hypertension (assessed at screening day: higher than 139 systolic and 89 diastolic)
• 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)
• 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

Sponsors & Collaborators

• University of Zurich: lead
• Schweizerischer Nationalfonds: collaborator

Study Sites (1)

Psychiatrische Universitätsklinik Zürich

Zurich, 8032, Switzerland

Location

Related Publications (1)

• Rieser NM, Bitar R, Halm S, Rossgoderer C, Gubser LP, Thevenaz M, Kreis Y, von Rotz R, Nordt C, Visentini M, Moujaes F, Engeli EJE, Ort A, Seifritz E, Vollenweider FX, Herdener M, Preller KH. Psilocybin-assisted therapy for relapse prevention in alcohol use disorder: a phase 2 randomized clinical trial. EClinicalMedicine. 2025 Mar 14;82:103149. doi: 10.1016/j.eclinm.2025.103149. eCollection 2025 Apr.

  PMID: 40144690 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Katrin Preller, Dr.

  Psychiatric University Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: double-blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase II, randomized, double blind, placebo controlled, parallel group, single center study

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 28, 2019
• Study Start: June 8, 2020
• Primary Completion: March 14, 2023
• Study Completion: September 14, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)