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Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05416229
Recruitment Status : Not yet recruiting
First Posted : June 13, 2022
Last Update Posted : September 2, 2022
Sponsor:
Collaborator:
The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
Information provided by (Responsible Party):
Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet

Tracking Information
First Submitted Date  ICMJE May 30, 2022
First Posted Date  ICMJE June 13, 2022
Last Update Posted Date September 2, 2022
Estimated Study Start Date  ICMJE October 2022
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2022)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2022)
  • Change in total alcohol consumption [ Time Frame: Baseline to week 12 ]
    Total grams of alcohol consumed per day as measured by TLFB.
  • Change in days of abstinence [ Time Frame: Baseline to week 12 ]
    Percentage of days without any alcohol consumption as measured by TLFB.
  • Change in phosphatidyl-ethanol (PEth) [ Time Frame: Baseline to week 12 ]
    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.
  • Change in Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Baseline to week 12 ]
    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.
  • Change in Penn Alcohol Craving Scale (PACS) score [ Time Frame: Baseline to week 12 ]
    PACS is a 40-item questionnaire that measures alcohol craving severity. The score range is 0-30, with higher scores indicating more severe symptoms.
  • Change in Alcohol Abstinence Self-efficacy Scale (AASE) score [ Time Frame: Baseline to week 12 ]
    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.
  • Change in Fagerstrom Test for Nicotine Dependence (FTND) [ Time Frame: Baseline to week 12 ]
    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.
  • Change in Drug Use Disorders Identification Test (DUDIT) [ Time Frame: Baseline to week 12 ]
    DUDIT is an 11-item questionnaire that measures drug use. The score range is 0-44, with higher scores indication a more problematic use.
  • Change in Major Depression Inventory (MDI) [ Time Frame: Baseline to week 12 ]
    MDI is a 12-item questionnaire that measures depression severity. The score range is 0-50, with higher scores indicating greater severity.
  • Change in Short-Form 36 (SF-36) [ Time Frame: Baseline to week 12 ]
    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.
  • Change in Mindful Attention Awareness Scale (MAAS) [ Time Frame: Baseline to week 12 ]
    MAAS is a 15-item scale that measures core characteristic of mindfulness. The score range is 1-6, with higher scores indicating greater mindfulness.
  • Change in Acceptance and Action Questionnaire (AAQ) [ Time Frame: Baseline to week 12 ]
    AAQ is a 7-item questionnaire that measures psychological flexibility. The score range is 7-49, with higher scores indicating lesser flexibility.
  • Change in NEO-Personality Inventory (NEO-PI= [ Time Frame: Baseline to week 12 ]
    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.
  • Persisting Effects Questionnaire (PEQ) [ Time Frame: Week 12 ]
    PEQ is a 143-item scale aiming to assess changes in attitudes, moods, behavior, and spiritual experience
  • Neuroplasticity and inflammation [ Time Frame: Baseline to week 12 ]
    Neuroplasticity and inflammation as measured by mean concentrations of plasma serum brain-derived neurotrophic factor (BDNF) and plasma cytokines, respectively.
  • Subjective effects of psilocybin: Subjective Drug Intensity (SDI) [ Time Frame: 0-6 hours post dosing ]
    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.
  • Pharmacokinetics- and dynamics of psilocybin [ Time Frame: 0 - 6 hours post dosing ]
    Pharmacokinetics- and dynamics of plasma psilocin, serum BDNF and plasma cytokines, as determined by concentration-time curves of mean plasma concentrations
  • Subjective effects of psilocybin: Mystical Experience Questionnaire (MEQ) [ Time Frame: Completed once the effects are fully subsided or at least 6 hours after dosing ]
    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.
  • 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 ]
    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).
  • Subjective effects of psilocybin: Ego Dissolution Inventory (EDI) [ Time Frame: Completed once the effects are fully subsided or at least 6 hours after dosing ]
    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).
  • Subjective effects of psilocybin: Emotional Breakthrough Inventory (EBI) [ Time Frame: Completed once the effects are fully subsided or at least 6 hours after dosing ]
    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).
  • 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 ]
    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.
  • Brain imaging [ Time Frame: 1 week post dosing ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2022)
  • Change in days of abstinence [ Time Frame: Baseline to week 12 ]
    Percentage of days without any alcohol consumption as measured by TLFB.
  • Change in total alcohol consumption [ Time Frame: Baseline to week 12 ]
    Total grams of alcohol consumed per day as measured by TLFB.
  • Change in phosphatidyl-ethanol (PEth) [ Time Frame: Baseline to week 12 ]
    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.
  • Change in Penn Alcohol Craving Scale (PACS) score [ Time Frame: Baseline to week 12 ]
    PACS is a 40-item questionnaire that measures alcohol craving severity. The score range is 0-30, with higher scores indicating more severe symptoms.
  • Change in Alcohol Abstinence Self-efficacy Scale (AASE) score [ Time Frame: Baseline to week 12 ]
    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.
  • Change in Major Depression Inventory (MDI) [ Time Frame: Baseline to week 12 ]
    MDI is a 12-item questionnaire that measures depression severity. The score range is 0-50, with higher scores indicating greater severity.
  • Change in Short-Form 36 (SF-36) [ Time Frame: Baseline to week 12 ]
    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.
  • Change in Mindful Attention Awareness Scale (MAAS) [ Time Frame: Baseline to week 12 ]
    MAAS is a 15-item scale that measures core characteristic of mindfulness. The score range is 1-6, with higher scores indicating greater mindfulness.
  • Change in Acceptance and Action Questionnaire (AAQ) [ Time Frame: Baseline to week 12 ]
    AAQ is a 7-item questionnaire that measures psychological flexibility. The score range is 7-49, with higher scores indicating lesser flexibility.
  • Neuroplasticity and inflammation [ Time Frame: Baseline to week 12 ]
    Neuroplasticity and inflammation as measured by mean concentrations of plasma serum brain-derived neurotrophic factor (BDNF) and plasma cytokines, respectively.
  • Subjective effects of psilocybin: Subjective Drug Intensity (SDI) [ Time Frame: 0-6 hours post dosing ]
    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.
  • Subjective effects of psilocybin: Mystical Experience Questionnaire (MEQ) [ Time Frame: Completed once the effects are fully subsided or at least 6 hours after dosing ]
    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.
  • 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 ]
    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).
  • 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 ]
    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.
  • Subjective effects of psilocybin: Ego Dissolution Inventory (EDI) [ Time Frame: Completed once the effects are fully subsided or at least 6 hours after dosing ]
    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).
  • Subjective effects of psilocybin: Emotional Breakthrough Inventory (EBI) [ Time Frame: Completed once the effects are fully subsided or at least 6 hours after dosing ]
    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).
  • Pharmacokinetics- and dynamics of psilocybin [ Time Frame: 0 - 6 hours post dosing ]
    Pharmacokinetics- and dynamics of plasma psilocin, serum BDNF and plasma cytokines, as determined by concentration-time curves of mean plasma concentrations
  • Brain imaging [ Time Frame: 1 week post dosing ]
    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
Current Other Pre-specified Outcome Measures
 (submitted: August 31, 2022)
  • Role of the Music I [ Time Frame: before and after dosing ]
    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
  • Role of the Music II [ Time Frame: week 4 ]
    We will explore the role of the music in psilocybin-assisted therapy by qualitative semi-structured interview
  • Treatment expectancies [ Time Frame: Baseline ]
    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)
  • Optional long-term follow-ups [ Time Frame: week 26 and week 52 ]
    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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder
Official Title  ICMJE 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.
Brief 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).

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
single-centre, randomised, double-blinded, placebo-controlled, 1:1 parallel-group clinical trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder
Intervention  ICMJE
  • Drug: Psilocybin
    Psilocybin-assisted therapy
  • Drug: Lactose
    Placebo-assisted therapy
Study Arms  ICMJE
  • Experimental: Psilocybin-assisted therapy
    45 patients will receive a single administration of 25mg psilocybin given in a protocol of psychological support before, during and after dosing.
    Intervention: Drug: Psilocybin
  • Placebo Comparator: Placebo-assisted therapy
    45 patients will receive a single administration of placebo (lactose) given in a protocol of psychological support before, during and after dosing.
    Intervention: Drug: Lactose
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2022)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mathias E Jensen, MD +45 61634663 mathias.ebbesen.jensen.01@regionh.dk
Contact: Anders Fink-Jensen, Professor +45 22755843 anders.fink-jensen@regionh.dk
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05416229
Other Study ID Numbers  ICMJE PSILO4ALCO-TRIAL
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Time Frame: Immediately following publication. No end date.
Access Criteria: Researchers who provide a methodologically sound proposal.
Current Responsible Party Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Anders Fink-Jensen, MD, DMSci
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
Investigators  ICMJE
Principal Investigator: Anders Fink-Jensen, Professor Psychiatric Center Copenhagen, Rigshospitalet
PRS Account Psychiatric Centre Rigshospitalet
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP