A Phase 2 interventional study of Psilocybin and Maltodextrin in Alcohol Use Disorder, sponsored by Anders Fink-Jensen, MD, DMSci. Completed at 1 site in Denmark. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by Anders Fink-Jensen, MD, DMSci · Phase 2, Interventional, and Treatment
Note: The trial is only eligible for citizens of Denmark.
The purpose of this project is to assess the treatment efficacy of a single high dose of psilocybin administered within a protocol of psychological support to patients diagnosed with alcohol use disorder (AUD).
To establish efficacy, we will investigate a single dose of psilocybin versus placebo in a randomised, double-blinded, placebo-controlled 12 weeks clinical trial. 90 patients, aged 20-70 years, diagnosed with alcohol use disorder and treatment seeking will be recruited from the community via advertisement and referrals from general practitioners and hospital units. The psilocybin or placebo is administered within a protocol of psychological support before, during and after the dosing. Outcome assessments will be carried out one, four, eight- and 12 weeks post dosing. The primary outcome is reduction in the percentage of heavy drinking days from baseline to follow-up at 12 weeks. Key secondary outcomes include 1) phosphatidyl-ethanol as an objective biomarker for alcohol consumption 2) plasma psilocin, the active metabolite, to establish a possible therapeutic range and 3) the acute subjective drug experience as a possible predictor of treatment outcome. Furthermore, we will investigate the neurobiological underpinnings of the possible treatment effects by use of functional magnetic resonance brain imaging one week post dosing.
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 60 is below the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Anders Fink-Jensen, MD, DMSci is the lead sponsor of 11 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
45 patients will receive a single administration of 25mg psilocybin given in a protocol of psychological support before, during and after dosing.
Drug: Psilocybin
45 patients will receive a single administration of placebo (lactose) given in a protocol of psychological support before, during and after dosing.
Drug: Maltodextrin
Psilocybin-assisted therapy
Placebo-assisted therapy
Change in percentage of heavy drinking days
Heavy drinking is defined as days with five drinks/60 grams of alcohol or more for men, four drinks/48 grams of alcohol or more for women. Data will be collected using the Timeline Followback Method (TLFB) which is a widely used, calendar-based retrospective measure of self-reported use of alcohol. The number of days drinking assessed is 28 days.
Time frame: Baseline to week 12
Change in total alcohol consumption
Total grams of alcohol consumed per day as measured by TLFB.
Time frame: Baseline to week 12
Change in days of abstinence
Percentage of days without any alcohol consumption as measured by TLFB.
Time frame: Baseline to week 12
Change in phosphatidyl-ethanol (PEth)
PEth is formed only in the presence of alcohol and is correlated with the amount of alcohol consumed the past month. PEth concentrations will be measured by peripheral blood test.
Time frame: Baseline to week 12
Change in Alcohol Use Disorders Identification Test (AUDIT)
AUDIT is a 10-item questionnaire that measures alcohol use. The score range is 0-40, with higher scores indicating a more problematic use of alcohol.
Time frame: Baseline to week 12
Change in Penn Alcohol Craving Scale (PACS) score
PACS is a 40-item questionnaire that measures alcohol craving severity. The score range is 0-30, with higher scores indicating more severe symptoms.
Time frame: Baseline to week 12
Change in Alcohol Abstinence Self-efficacy Scale (AASE) score
AASE is a 40-item questionnaire that measures two scales: the temptation to drink and the confidence in the ability to avoid drinking. The score range for each scale is 0-80, with higher score indicating greater temptation or confidence, respectively.
Time frame: Baseline to week 12
Change in Fagerstrom Test for Nicotine Dependence (FTND)
FTND is a 6-item questionnaire that measures the quantity of cigarette consumption, the compulsion to use, and dependence. The score range is 0-10, with higher scores indicating a more severe dependence.
Time frame: Baseline to week 12
Change in Drug Use Disorders Identification Test (DUDIT)
DUDIT is an 11-item questionnaire that measures drug use. The score range is 0-44, with higher scores indication a more problematic use.
Time frame: Baseline to week 12
Change in Major Depression Inventory (MDI)
MDI is a 12-item questionnaire that measures depression severity. The score range is 0-50, with higher scores indicating greater severity.
Time frame: Baseline to week 12
Change in Short-Form 36 (SF-36)
SF-36 is a 36-item questionnaire that measures the quality-of-life. The score range is 0-100, with higher scores indicating better health status.
Time frame: Baseline to week 12
Change in Mindful Attention Awareness Scale (MAAS)
MAAS is a 15-item scale that measures core characteristic of mindfulness. The score range is 1-6, with higher scores indicating greater mindfulness.
Time frame: Baseline to week 12
Change in Acceptance and Action Questionnaire (AAQ)
AAQ is a 7-item questionnaire that measures psychological flexibility. The score range is 7-49, with higher scores indicating lesser flexibility.
Time frame: Baseline to week 12
Change in NEO-Personality Inventory (NEO-PI=
The NEO-PI is a 240-item personality instrument that measures the five factors in the Five Factor Model. It consists of 30 eight-item facet scales, 6 for each of the five basic personality factors: Neuroticism (N), Extraversion (E), Openness (O), Agreeableness (A), and Conscientiousness (C), rated by use of a 5-point Likert-type scale ranging from strongly disagree to strongly agree.
Time frame: Baseline to week 12
Persisting Effects Questionnaire (PEQ)
PEQ is a 143-item scale aiming to assess changes in attitudes, moods, behavior, and spiritual experience
Time frame: Week 12
Neuroplasticity and inflammation
Neuroplasticity and inflammation as measured by mean concentrations of plasma serum brain-derived neurotrophic factor (BDNF) and plasma cytokines, respectively.
Time frame: Baseline to week 12
Subjective effects of psilocybin: Subjective Drug Intensity (SDI)
SDI will be regularly assessed 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.
Time frame: 0-6 hours post dosing
Pharmacokinetics- and dynamics of psilocybin
Pharmacokinetics- and dynamics of plasma psilocin, serum BDNF and plasma cytokines, as determined by concentration-time curves of mean plasma concentrations
Time frame: 0 - 6 hours post dosing
Subjective effects of psilocybin: Mystical Experience Questionnaire (MEQ)
MEQ is a 30-item questionnaire that measures experiential aspects of psilocybin. 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.
Time frame: Completed once the effects are fully subsided or at least 6 hours after dosing
Subjective effects of psilocybin: 5-Dimensional Altered State of Consciousness scale (5D-ASC)
5D-ASC is a 94-item questionnaire that measures experiential aspects of psilocybin. 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).
Time frame: Completed once the effects are fully subsided or at least 6 hours after dosing
Subjective effects of psilocybin: Ego Dissolution Inventory (EDI)
EDI is a 8-item questionnaire that measures the experiential aspects of psilocybin. 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).
Time frame: Completed once the effects are fully subsided or at least 6 hours after dosing
Subjective effects of psilocybin: Emotional Breakthrough Inventory (EBI)
EBI is a 6-item questionnaire that measures the experiential aspects of psilocybin. 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).
Time frame: Completed once the effects are fully subsided or at least 6 hours after dosing
Subjective effects of psilocybin: Awe Experience Scale (AWE-S)
AWE-S is a 30-item questionnaire that measures the experiential aspects of psilocybin. The patients are asked to rate the items on a 7-point scale going from 1= Strongly Disagree to 7= Strongly Agree.
Time frame: Completed once the effects are fully subsided or at least 6 hours after dosing
Brain imaging
The blood-oxygen-level-dependent differences between the two treatment arms with respect to resting-state functional connectivity, alcohol vs neutral cue-reactivity within mesocorticolimbic pathways and habitual vs goal-directed activity within corticostriatal pathways
Time frame: 1 week post dosing
Role of the Music I
We will explore the role of the music in psilocybin-assisted therapy by use of the questionnaires Experience with Music and Geneva Emotional Music Scale
Time frame: before and after dosing
Role of the Music II
We will explore the role of the music in psilocybin-assisted therapy by qualitative semi-structured interview
Time frame: week 4
Treatment expectancies
The Stanford Expectations of Treatment Scale is a 6 item a scale that measures positive and negative treatment expectancies using a Likert scale from 1 (strongly disagree) to 7 (strongly agree)
Time frame: Baseline
Optional long-term follow-ups
Patients may consent to post-trial follow-up to explore the long-term effects on drinking outcomes using TLFB adjusted for current or previous treatments since completing the trial.
Time frame: week 26 and week 52
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — All of the individual participant data collected during the trial, after deidentification.
Supporting information: Study protocol, Sap
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Anders Fink-Jensen, MD, DMSci