Alcohol Use Disorder (AUD)Phase 2NCT04718792
Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
A Phase 2 study testing Psilocybin in people with Alcohol Use Disorder (AUD), run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Psilocybin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Feb 2023to 21 Jul 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of 20-70 years (both included).
- Body weight of 60-95 kg (both included).
- Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
- Alcohol Use Disorder Identification Test (AUDIT) ≥ 15.
- ≥ 5 heavy drinking days.
Who cannot join
- Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
- History of delirium tremens or alcohol withdrawal seizures.
- History of suicide attempt or present suicidal ideation.
- Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
- Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.
- Impaired hepatic function (liver transaminases > 3 times upper normal limit).
Show all 17Show fewer
- Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
- Abnormal electrocardiogram
- Impaired renal function (eGFR < 50 ml/min).
- Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
- Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
- Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
- 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.
- Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective61.
- Hypersensitivity to the active substance or to any of the excipients.
- Unable to speak and/or understand Danish.
- Any condition that the investigator feels would interfere with trial participation.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Psilocybin
- Keywords
- psilocybin, alcohol use disorder, psychedelics, addiction, pharmacokinetics, psilocin, feasibility
- Medical subject headings
- Alcoholism, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | 10 patients will receive a single administration of psilocybin Receives: Drug: Psilocybin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Adverse events associated with administration of psilocybin in patients diagnosed with alcohol use disorder
Assessment of the incidence and severity of expected and unexpected adverse events
Measured: 12 week after drug administration
Secondary outcomes (25)
Feasibility: Proportion of participants who complete
Proportion of included patients who complete the planned procedures
Measured: 1 week after drug administration
Pharmacokinetic parameter of psilocin: Cmax
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data. Blood samples will be drawn with intervals of 20 minutes
Measured: From drug administration and 360 minutes after.
Pharmacokinetic parameter of psilocin: Tmax
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
Measured: From drug administration to 360 minutes after.
Pharmacokinetic parameter of psilocin: AUC
AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.
Measured: From drug administration to 360 minutes after.
Pharmacokinetic parameter of brain-derived neurotropic factor
Acute and subacute changes in plasma and wholeblod brain-derived neurotropic factor (BDNF)
Measured: From drug administration to 360 minutes after and 1 week after
Pharmacokinetic parameter of cytokines
Acute and subacute changes in plasma cytokines including tumour necrosis factor alpha, interleukin-4 and 6.
Measured: From drug administration to 360 minutes after and 1 week after
Pharmacodynamics of cardiovascular measures
Acute changes in systolic and diastolic blood pressure (mmHg)
Measured: From drug administration to 360 minutes after
Pharmacodynamics of cardiovascular measures
Acute changes in heart rate (beats per minute)
Measured: From drug administration to 360 minutes after
Subjective effects of psilocybin: Intensity
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.
Measured: From drug administration to 8 hours after
Subjective effects of psilocybin: Mystical Experience
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.
Measured: 8 hours after drug administration
Subjective effects of psilocybin: Altered States of Consciousness
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).
Measured: 8 hours after drug administration
Subjective effects of psilocybin: Awe Experience
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.
Measured: 8 hours after drug administration
Subjective effects of psilocybin: Ego Dissolution
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).
Measured: 8 hours after drug administration
Change in heavy drinking days
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
Measured: Baseline, 4, 12 and 52 weeks after drug administration
Change in drinks per day
Change in drinks per day in the past 28 days as quantified by the Timeline Followback Method
Measured: Baseline, 4, 12 and 52 weeks after drug administration
Change in drinking days
Change in drinking days in the past 28 days as quantified by the Timeline Followback Method
Measured: Baseline, 4, 12 and 52 weeks after drug administration
Change in alcohol use
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
Measured: Baseline, 12 and 52 week after drug administration
Change in craving
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.
Measured: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in self-efficacy
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.
Measured: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in mindfulness
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.
Measured: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in psychological flexibility
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.
Measured: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Change in depressive symptoms
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.
Measured: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Expectancy to treatment
Assessment of the patients expectations before the treatment as measured by the Stanford Expectations of Treatment Scale (SETS).
Measured: Baseline
Persisting Effects
Assessment of eight categories of possible changes in attitudes, mood, social effects, and behavior after drug administration
Measured: 4, 12 and 52 weeks after drug administration
Change in personality traits
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)
Measured: Baseline and Week 12 after drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start9 Feb 2023
- Primary completion21 Jul 2024 (estimated)
- Study completion21 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label study
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anders Fink-Jensen, MD, DMSci
- Sponsor type
- University, hospital or other
- Collaborators
- The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
- Responsible party
- Sponsor-investigator, Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
- Investigators
- Anders Fink-Jensen, Professor, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04718792
- Sponsor's protocol ID
- PSILO4ALCO-FEASIBILITY
- Status last verified
- Jul 2024
- First submitted
- 8 Jan 2021
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jensen ME, Stenbaek DS, Messell CD, Poulsen ED, Varga TV, Fisher PM, Nielsen MKK, Johansen SS, Volkow ND, Knudsen GM, Fink-Jensen A. Single-dose psilocybin therapy for alcohol use disorder: Pharmacokinetics, feasibility, safety and efficacy in an open-label study. J Psychopharmacol. 2025 May;39(5):463-473. doi: 10.1177/02698811251319457. Epub 2025 Feb 28.
PubMed 40018886
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
- ClinicalTrials.gov ID
- NCT04718792
- Acronym / sponsor ID
- PSILO4ALCO-FEASIBILITY
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- psilocybin, alcohol use disorder, psychedelics, addiction, pharmacokinetics, psilocin, feasibility
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Anders Fink-Jensen, MD, DMSciUniversity, hospital or other
- Collaborators
- The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
- Study start
- 9 Feb 2023 (actual)
- Primary completion
- 21 Jul 2024 (estimated)
- Study completion
- 21 Jul 2024 (estimated)
- First posted
- 22 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label study
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: Psilocybin10 patients will receive a single administration of psilocybin |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of 20-70 years (both included).
- Body weight of 60-95 kg (both included).
- Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
- Alcohol Use Disorder Identification Test (AUDIT) ≥ 15.
- ≥ 5 heavy drinking days.
Key exclusion criteria (17 listed)
- Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
- History of delirium tremens or alcohol withdrawal seizures.
- History of suicide attempt or present suicidal ideation.
- Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
- Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsilocybinA 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) | Drug | Psilocybin |
Primary outcome
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
25 secondary outcomes
Feasibility: Proportion of participants who complete
Time frame: 1 week after drug administration
Pharmacokinetic parameter of psilocin: Cmax
Time frame: From drug administration and 360 minutes after.
Pharmacokinetic parameter of psilocin: Tmax
Time frame: From drug administration to 360 minutes after.
Pharmacokinetic parameter of psilocin: AUC
Time frame: 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
Pharmacokinetic parameter of cytokines
Time frame: From drug administration to 360 minutes after and 1 week after
Pharmacodynamics of cardiovascular measures
Time frame: From drug administration to 360 minutes after
Pharmacodynamics of cardiovascular measures
Time frame: From drug administration to 360 minutes after
Subjective effects of psilocybin: Intensity
Time frame: From drug administration to 8 hours after
Subjective effects of psilocybin: Mystical Experience
Time frame: 8 hours after drug administration
Subjective effects of psilocybin: Altered States of Consciousness
Time frame: 8 hours after drug administration
Subjective effects of psilocybin: Awe Experience
Time frame: 8 hours after drug administration
Subjective effects of psilocybin: Ego Dissolution
Time frame: 8 hours after drug administration
Change in heavy drinking days
Time frame: 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 drinking days
Time frame: 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 craving
Time frame: 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 mindfulness
Time frame: 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 depressive symptoms
Time frame: Baseline, 1 week, 4 week, 12 and 52 week after drug administration
Expectancy to treatment
Time frame: Baseline
Persisting Effects
Time frame: 4, 12 and 52 weeks after drug administration
Change in personality traits
Time frame: Baseline and Week 12 after drug administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 40018886Jensen ME, Stenbaek DS, Messell CD, Poulsen ED, Varga TV, Fisher PM, Nielsen MKK, Johansen SS, Volkow ND, Knudsen GM, Fink-Jensen A. Single-dose psilocybin therapy for alcohol use disorder: Pharmacokinetics, feasibility, safety and efficacy in an open-label study. J Psychopharmacol. 2025 May;39(5):463-473. doi: 10.1177/02698811251319457. Epub 2025 Feb 28.
Related trials for Alcohol Use Disorder (AUD)
Not yet recruiting
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
Alcohol Use Disorder (AUD), Suicidal Ideation
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Not yet recruitingObservational study
Disease Intervention Specialist (DIS) for SUD
Substance Use Disorder (SUD), Opioid Use Disorder
Not yet recruiting
eTSF for Latinx Young Adults With Alcohol Use Disorder
Alcohol Use Disorder (AUD)
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Fink-Jensen, Professor principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin in people with Alcohol Use Disorder (AUD), run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Adverse events associated with administration of psilocybin in patients diagnosed with alcohol use disorder (time frame: 12 week after drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04718792, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024; AzTrials last refreshed its copy on 7 Nov 2026.