Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin | Drug | Psilocybin-assisted therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in total alcohol consumption | Total grams of alcohol consumed per day as measured by TLFB. | Baseline to week 12 |
| Change in days of abstinence | Percentage of days without any alcohol consumption as measured by TLFB. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | before and after dosing |
| Role of the Music II |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Anders Fink-Jensen, Professor | Psychiatric Center Copenhagen, Frederiksberg Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Center Copenhagen, Frederiksberg Hospital | Frederiksberg | 2000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36241352 | Derived | 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. |
Not provided
Not provided
All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
Researchers who provide a methodologically sound proposal.
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 17, 2026 | Feb 17, 2026 | SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D016739 | Behavior, Addictive |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D011562 | Psilocybin |
| C008315 | maltodextrin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
Not provided
Not provided
single-centre, randomised, double-blinded, placebo-controlled, 1:1 parallel-group clinical trial
Not provided
Not provided
Not provided
| Maltodextrin |
| Drug |
Placebo-assisted therapy |
|
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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. | 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. | 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 | 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. | 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). | 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). | 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). | 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. | 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 | 1 week post dosing |
We will explore the role of the music in psilocybin-assisted therapy by qualitative semi-structured interview
| 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) | 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. | week 26 and week 52 |
| D003192 | Compulsive Behavior |
| D007175 | Impulsive Behavior |
| D001519 | Behavior |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |