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| Name | Class |
|---|---|
| The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin | Experimental | 10 patients will receive a single administration of psilocybin |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 week after drug administration |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility: Proportion of participants who complete | Proportion of included patients who complete the planned procedures | 1 week after drug administration |
| Pharmacokinetic parameter of psilocin: Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anders Fink-Jensen, Professor | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Center Copenhagen | Copenhagen | Frederiksberg | 2000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40018886 | Derived | 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. |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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Open label study
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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 | 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 | 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 | 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 | 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 | Acute changes in systolic and diastolic blood pressure (mmHg) | From drug administration to 360 minutes after |
| Pharmacodynamics of cardiovascular measures | Acute changes in heart rate (beats per minute) | 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. | 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. | 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). | 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. | 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). | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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). | Baseline |
| Persisting Effects | 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 | 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 |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |