Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

July 9, 2024 updated by: Anders Fink-Jensen, MD, DMSci
The purpose of this project is to assess the feasibility and safety of administering a single dose of psilocybin to patients diagnosed with alcohol use disorder (AUD). In addition the investigators will establish the pharmacokinetic properties of the active metabolite psilocin. This is the first step in a research project that has the overall aim to evaluate the efficacy of a single administration of psilocybin as an intervention for treatment of AUD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The investigators will evaluate the feasibility and safety of administering psilocybin to 10 patients diagnosed with AUD. Following informed consent, patients will be screened for eligibility as per in- and exclusion criteria and baseline values will be recorded as per outcome measures. All patients will receive a single administration of 25 mg of psilocybin. As per safety guidelines patients will be monitored the entire dosing session by study staff familiar with the psychedelic effects of psilocybin. In addition, the patients will meet before and after the dosing session with a psychologist connected to the study for preparation and post-session debriefing, respectively. During dosing session, the investigators will collect blood plasma psilocin levels in order to establish pharmacokinetics and an estimated brain 5-HT2AR occupancy. When the effects of psilocybin subside, the investigators will ask the patients to fill out questionnaires encapsulating the psychedelic experience. One week after drug administration the patients are required to meet for an end-of-study assessment of outcome measures including adverse events.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
    • Frederiksberg
      • Copenhagen, Frederiksberg, Denmark, 2000
        • Psychiatric Center Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age of 20-70 years (both included).
  2. Body weight of 60-95 kg (both included).
  3. Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
  4. Alcohol Use Disorder Identification Test (AUDIT) ≥ 15.
  5. ≥ 5 heavy drinking days.

Exclusion Criteria:

  1. Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
  2. History of delirium tremens or alcohol withdrawal seizures.
  3. History of suicide attempt or present suicidal ideation.
  4. Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
  5. Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.
  6. Impaired hepatic function (liver transaminases > 3 times upper normal limit).
  7. Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
  8. Abnormal electrocardiogram
  9. Impaired renal function (eGFR < 50 ml/min).
  10. Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
  11. Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
  12. Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
  13. Any other active substance use defined as a Drug Use Disorder Identification Test score > 6/2 (m/w) and substance use disorder based on investigator's clinical evaluation, except for nicotine.
  14. Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective61.
  15. Hypersensitivity to the active substance or to any of the excipients.
  16. Unable to speak and/or understand Danish.
  17. Any condition that the investigator feels would interfere with trial participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Psilocybin
10 patients will receive a single administration of psilocybin
Drug: Psilocybin
A single administration of PEX010 (psilocybin 25 mg, opaque capsule for oral ingestion). PEX010 contains psilocybin (25 mg) naturally extracted from Psilocybe cubensis mushroom fruiting bodies, manufactured under current Good Manufacturing Practices (cGMP)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety: Adverse events associated with administration of psilocybin in patients diagnosed with alcohol use disorder
Time Frame: 12 week after drug administration
Assessment of the incidence and severity of expected and unexpected adverse events
12 week after drug administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility: Proportion of participants who complete
Time Frame: 1 week after drug administration
Proportion of included patients who complete the planned procedures
1 week after drug administration
Subjective effects of psilocybin: Intensity
Time Frame: From drug administration to 8 hours after
Intensity of the drug effect will be assessed with intervals of 20 minutes asking the patients "How intense is the experience right now" on a 0-10 Likert scale where 0 = not intense at all, 10 = very intense.
From drug administration to 8 hours after
Subjective effects of psilocybin: Mystical Experience
Time Frame: 8 hours after drug administration
Experiential aspects of psilocybin measured by The Mystical Experience Questionnaire (MEQ). The patients are asked to rate the items on a 6-point scale going from 0= none; not at all to 5=extreme; more than ever before in my life and stronger than 4.
8 hours after drug administration
Subjective effects of psilocybin: Altered States of Consciousness
Time Frame: 8 hours after drug administration
Experiential aspects of psilocybin measured by the 11-Dimensional Altered State of Consciousness scale (11-DASC). The patients are asked to rate the items by placing marks on a horizontal visual analogue scale (100 millimeters in length) going from "no, not more than usual" (on the left) to "yes, very much more than usual" (on the right).
8 hours after drug administration
Subjective effects of psilocybin: Awe Experience
Time Frame: 8 hours after drug administration
Experiential aspects of psilocybin measured by the Awe Experience Scale. The patients are asked to rate the items on a 7-point scale going from 1= Strongly Disagree to 7= Strongly Agree.
8 hours after drug administration
Subjective effects of psilocybin: Ego Dissolution
Time Frame: 8 hours after drug administration
Experiential aspects of psilocybin measured by the Ego Dissolution Inventory. The patients are asked to rate the items by placing marks on a horizontal visual analogue scale (100 millimeters in length) going from "no, not more than usual" (on the left) to "yes, very much more than usual" (on the right).
8 hours after drug administration
Pharmacokinetic parameter of psilocin: Cmax
Time Frame: From drug administration and 360 minutes after.
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data. Blood samples will be drawn with intervals of 20 minutes
From drug administration and 360 minutes after.
Pharmacokinetic parameter of psilocin: Tmax
Time Frame: From drug administration to 360 minutes after.
Tmax: Time to reach maximum concentration of plasma psilocin determined from concentrations-versus-time data. Blood samples will be drawn with intervals of 20 minutes
From drug administration to 360 minutes after.
Pharmacokinetic parameter of psilocin: AUC
Time Frame: From drug administration to 360 minutes after.
AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.
From drug administration to 360 minutes after.
Pharmacokinetic parameter of brain-derived neurotropic factor
Time Frame: From drug administration to 360 minutes after and 1 week after
Acute and subacute changes in plasma and wholeblod brain-derived neurotropic factor (BDNF)
From drug administration to 360 minutes after and 1 week after
Pharmacokinetic parameter of cytokines
Time Frame: From drug administration to 360 minutes after and 1 week after
Acute and subacute changes in plasma cytokines including tumour necrosis factor alpha, interleukin-4 and 6.
From drug administration to 360 minutes after and 1 week after
Pharmacodynamics of cardiovascular measures
Time Frame: From drug administration to 360 minutes after
Acute changes in systolic and diastolic blood pressure (mmHg)
From drug administration to 360 minutes after
Pharmacodynamics of cardiovascular measures
Time Frame: From drug administration to 360 minutes after
Acute changes in heart rate (beats per minute)
From drug administration to 360 minutes after
Change in heavy drinking days
Time Frame: Baseline, 4, 12 and 52 weeks after drug administration
Change in heavy drinking day, defined as consuming 60/48 g (men/women) of alcohol or more on any day, in the past 28 days as quantified by the Timeline Followback Method
Baseline, 4, 12 and 52 weeks after drug administration
Change in drinks per day
Time Frame: Baseline, 4, 12 and 52 weeks after drug administration
Change in drinks per day in the past 28 days as quantified by the Timeline Followback Method
Baseline, 4, 12 and 52 weeks after drug administration
Change in drinking days
Time Frame: Baseline, 4, 12 and 52 weeks after drug administration
Change in drinking days in the past 28 days as quantified by the Timeline Followback Method
Baseline, 4, 12 and 52 weeks after drug administration
Change in alcohol use
Time Frame: Baseline, 12 and 52 week after drug administration
Change in self-reported alcohol use measured by the Alcohol Use Identification Test (AUDIT). The AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcoho
Baseline, 12 and 52 week after drug administration
Change in craving
Time Frame: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in self-reported craving measured by the Penn Alcohol Craving Scale (PACS). The patients are asked to rate the items on a 7-point scale going from 0= Never to 6= Nearly all of the time.
Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in self-efficacy
Time Frame: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in self-reported self-efficacy measured by the Alcohol Abstinence Self-efficacy (AASE). The patients are asked to rate the items on a 5-point scale going from 1= not at all to 5= extremely.
Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in mindfulness
Time Frame: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in self-reported mindfulness measured by the Mindful Attention Awareness Scale (MAAS). The patients are asked to rate the items on a 6-point scale going from 1= Almost always to 6= Almost never.
Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in psychological flexibility
Time Frame: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in self-reported flexibility measured by the Acceptance and Action Questionnaire (AAQ). The patients are asked to rate the items on a 7-point scale going from 1= Never true to 7= Always true.
Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in depressive symptoms
Time Frame: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in self-reported depression symptoms measured by the Major Depressive Inventory (MDI). The patients are asked to rate the items on a 6-point scale going from 1= Always to 7= Never.
Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Expectancy to treatment
Time Frame: Baseline
Assessment of the patients expectations before the treatment as measured by the Stanford Expectations of Treatment Scale (SETS).
Baseline
Persisting Effects
Time Frame: 4, 12 and 52 weeks after drug administration
Assessment of eight categories of possible changes in attitudes, mood, social effects, and behavior after drug administration
4, 12 and 52 weeks after drug administration
Change in personality traits
Time Frame: Baseline and Week 12 after drug administration
Change in personality traits as measured by NEO Five-Factor Inventory-3 (NEO-FFI-3). NEO-FFI is 60 items measuring five dimensions of personality: Agreeableness (A), Conscientiousness (C), Neuroticism (N), Extraversion (E), and Openness to Experience (O)
Baseline and Week 12 after drug administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anders Fink-Jensen, MD, DMSci

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anders Fink-Jensen, Professor, PROFESSOR

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 21, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 17, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PSILO4ALCO-FEASIBILITY

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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