Alcohol Use DisorderPhase 2NCT05416229
Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder
A Phase 2 study testing Psilocybin and Maltodextrin in people with Alcohol Use Disorder, run by Anders Fink-Jensen, MD, DMSci at 1 site in Denmark.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- Psilocybin and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Sep 2023to 22 Dec 2025
- 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
- Bodyweight of 50-110 kg
- AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
- AUD Identification Test (AUDIT) ≥ 15.
- ≥ 5 heavy drinking days in the past 28 days prior to inclusion.
Who cannot join
- Current or previously diagnosed with any psychotic disorder or bipolar affective disorder.
- Immediate family member with a diagnosed psychotic disorder.
- History of delirium tremens or alcohol withdrawal seizures.
- History of suicide attempt or present suicidal ideation at screening.
- Withdrawal symptoms at screening (>nine on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (43).
- Present or former severe neurological disease including trauma with loss of consciousness > 30 min.
Show all 15Show fewer
- Impaired hepatic function (alanine transaminase >210/135 units/l men/women)
- Cardiovascular disease defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, myocardial infarction within the last 12 months or uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
- Present or former abnormal QTc (>450/470 ms men/women).
- Treatment with disulfiram, naltrexone, acamprosate and nalmefene within 28 days of inclusion.
- Treatment with any serotonergic medication or drugs within one month prior inclusion.
- Any oOther active substance use disorders (except nicotine) defined as a Drug Use Disorder Identification Test score >six/two (men/women) and investigator's clinical evaluation.
- Women who are pregnant, breastfeeding, or intend to become pregnant or are not using adequate contraceptive measures considered highly effective (44).
- Unable to speak or understand Danish.
- Any other condition that the clinician estimates can interfere with trial participation.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Psychiatric Center Copenhagen, Frederiksberg Hospital
Frederiksberg, 2000
About this study
Official title: The QUANTUM Trip Trial - Psilocybin-assisted Therapy for Reducing Alcohol Intake in Patients With Alcohol Use Disorder: A Randomized, Double-blinded, Placebo-controlled Clinical Trial.
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).
Read the detailed description
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.
- Conditions
- Alcohol Use Disorder
- Being tested
- Psilocybin, Maltodextrin
- Keywords
- psilocybin, alcohol dependence, addiction, randomized controlled trial, brain imaging
- 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
Psilocybin-assisted therapy
MaltodextrinDrug
Placebo-assisted therapy
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin-assisted therapy | Experimental | 45 patients will receive a single administration of 25mg psilocybin given in a protocol of psychological support before, during and after dosing. Receives: Drug: Psilocybin |
| Placebo-assisted therapy | Placebo comparator | 45 patients will receive a single administration of placebo (lactose) given in a protocol of psychological support before, during and after dosing. Receives: Drug: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to week 12
Secondary outcomes (23)
Change in total alcohol consumption
Total grams of alcohol consumed per day as measured by TLFB.
Measured: Baseline to week 12
Change in days of abstinence
Percentage of days without any alcohol consumption as measured by TLFB.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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
Measured: 1 week post dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Sep 2023
- Primary completion22 Dec 2025
- Study completion22 Dec 2025
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 DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-centre, randomised, double-blinded, placebo-controlled, 1:1 parallel-group clinical trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 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, Psychiatric Center Copenhagen, Frederiksberg Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416229
- Sponsor's protocol ID
- PSILO4ALCO-TRIAL
- Status last verified
- Mar 2026
- First submitted
- 30 May 2022
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Publications
Jensen ME, Stenbaek DS, Juul TS, Fisher PM, Ekstrom CT, Knudsen GM, Fink-Jensen A. Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial). BMJ Open. 2022 Oct 14;12(10):e066019. doi: 10.1136/bmjopen-2022-066019.
PubMed 36241352
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The QUANTUM Trip Trial - Psilocybin-assisted Therapy for Reducing Alcohol Intake in Patients With Alcohol Use Disorder: A Randomized, Double-blinded, Placebo-controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT05416229
- Acronym / sponsor ID
- PSILO4ALCO-TRIAL
- Conditions
- Alcohol Use Disorder
- Keywords
- psilocybin, alcohol dependence, addiction, randomized controlled trial, brain imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Anders Fink-Jensen, MD, DMSciUniversity, hospital or other
- Collaborators
- The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 22 Dec 2025 (actual)
- First posted
- 13 Jun 2022 (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.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- single-centre, randomised, double-blinded, placebo-controlled, 1:1 parallel-group clinical trial
| Arm | Type | Receives |
|---|---|---|
| Psilocybin-assisted therapy | Experimental | Drug: Psilocybin45 patients will receive a single administration of 25mg psilocybin given in a protocol of psychological support before, during and after dosing. |
| Placebo-assisted therapy | Placebo comparator | Drug: Maltodextrin45 patients will receive a single administration of placebo (lactose) given in a protocol of psychological support before, during and after dosing. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Bodyweight of 50-110 kg
- AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
- AUD Identification Test (AUDIT) ≥ 15.
- ≥ 5 heavy drinking days in the past 28 days prior to inclusion.
Key exclusion criteria (15 listed)
- Current or previously diagnosed with any psychotic disorder or bipolar affective disorder.
- Immediate family member with a diagnosed psychotic disorder.
- History of delirium tremens or alcohol withdrawal seizures.
- History of suicide attempt or present suicidal ideation at screening.
- Withdrawal symptoms at screening (>nine on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (43).
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 |
|---|---|---|
| PsilocybinPsilocybin-assisted therapy | Drug | Psilocybin-assisted therapy |
| MaltodextrinPlacebo-assisted therapy | Drug | Placebo-assisted therapy |
Primary outcome
Change in percentage of heavy drinking days
Time frame: Baseline to week 12
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.
23 secondary outcomes
Change in total alcohol consumption
Time frame: Baseline to week 12
Change in days of abstinence
Time frame: Baseline to week 12
Change in phosphatidyl-ethanol (PEth)
Time frame: Baseline to week 12
Change in Alcohol Use Disorders Identification Test (AUDIT)
Time frame: Baseline to week 12
Change in Penn Alcohol Craving Scale (PACS) score
Time frame: Baseline to week 12
Change in Alcohol Abstinence Self-efficacy Scale (AASE) score
Time frame: Baseline to week 12
Change in Fagerstrom Test for Nicotine Dependence (FTND)
Time frame: Baseline to week 12
Change in Drug Use Disorders Identification Test (DUDIT)
Time frame: Baseline to week 12
Change in Major Depression Inventory (MDI)
Time frame: Baseline to week 12
Change in Short-Form 36 (SF-36)
Time frame: Baseline to week 12
Change in Mindful Attention Awareness Scale (MAAS)
Time frame: Baseline to week 12
Change in Acceptance and Action Questionnaire (AAQ)
Time frame: Baseline to week 12
Change in NEO-Personality Inventory (NEO-PI=
Time frame: Baseline to week 12
Persisting Effects Questionnaire (PEQ)
Time frame: Week 12
Neuroplasticity and inflammation
Time frame: Baseline to week 12
Subjective effects of psilocybin: Subjective Drug Intensity (SDI)
Time frame: 0-6 hours post dosing
Pharmacokinetics- and dynamics of psilocybin
Time frame: 0 - 6 hours post dosing
Subjective effects of psilocybin: Mystical Experience Questionnaire (MEQ)
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)
Time frame: Completed once the effects are fully subsided or at least 6 hours after dosing
Subjective effects of psilocybin: Ego Dissolution Inventory (EDI)
Time frame: Completed once the effects are fully subsided or at least 6 hours after dosing
Subjective effects of psilocybin: Emotional Breakthrough Inventory (EBI)
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)
Time frame: Completed once the effects are fully subsided or at least 6 hours after dosing
Brain imaging
Time frame: 1 week post dosing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Derived from this study: PubMed 36241352Jensen ME, Stenbaek DS, Juul TS, Fisher PM, Ekstrom CT, Knudsen GM, Fink-Jensen A. Psilocybin-assisted therapy for reducing alcohol intake in patients with alcohol use disorder: protocol for a randomised, double-blinded, placebo-controlled 12-week clinical trial (The QUANTUM Trip Trial). BMJ Open. 2022 Oct 14;12(10):e066019. doi: 10.1136/bmjopen-2022-066019.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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
Psychiatric Center Copenhagen, Frederiksberg Hospital
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 and Maltodextrin in people with Alcohol Use Disorder, 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 4 inclusion and 15 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: finished, as of the sponsor's last update on 24 Mar 2026. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in percentage of heavy drinking days (time frame: Baseline to week 12). 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 NCT05416229, 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 24 Mar 2026.