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Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

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ClinicalTrials.gov Identifier: NCT04718792
Recruitment Status : Not yet recruiting
First Posted : January 22, 2021
Last Update Posted : January 28, 2021
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 January 8, 2021
First Posted Date  ICMJE January 22, 2021
Last Update Posted Date January 28, 2021
Estimated Study Start Date  ICMJE January 20, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 17, 2021)
Safety: Adverse events associated with administration of psilocybin in patients diagnosed with alcohol use disorder [ Time Frame: 1 week after drug administration ]
Assessment of the incidence and severity of expected and unexpected adverse events
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2021)
  • Feasibility: Proportion of participants who complete [ Time Frame: 1 week after drug administration ]
    Proportion of included patients who complete the planned procedures
  • Pharmacokinetic parameter of psilocin: Cmax [ Time Frame: From drug administration and 300 minutes after. ]
    Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data. Blood samples will be drawn with intervals of 20 minutes
  • Pharmacokinetic parameter of psilocin: Tmax [ Time Frame: From drug administration to 300 minutes after. ]
    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
  • Pharmacokinetic parameter of psilocin: AUC [ Time Frame: From drug administration to 300 minutes after. ]
    AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.
  • Subjective effects of psilocybin: Intensity [ Time Frame: From drug administration to 8 hours after ]
    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.
  • Subjective effects of psilocybin: Mystical Experience [ Time Frame: 8 hours after drug administration ]
    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.
  • Subjective effects of psilocybin: Altered States of Consciousness [ Time Frame: 8 hours after drug administration ]
    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).
  • Subjective effects of psilocybin: Awe Experience [ Time Frame: 8 hours after drug administration ]
    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.
  • Subjective effects of psilocybin: Ego Dissolution [ Time Frame: 8 hours after drug administration ]
    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).
  • Change in craving [ Time Frame: Baseline and 1 week after drug administration ]
    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.
  • Change in self-efficacy [ Time Frame: Baseline and 1 week after drug administration ]
    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.
  • Change in mindfulness [ Time Frame: Baseline and 1 week after drug administration ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
Official Title  ICMJE Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Open label study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Alcohol Use Disorder (AUD)
Intervention  ICMJE Drug: Psilocybin
A single administration psilocybin (25mg, opaque capsule for oral ingestion). The psilocybin is synthetically manufactured under current Good Manufacturing Practices (cGMP)
Study Arms  ICMJE Experimental: Psilocybin
10 patients will receive a single administration of psilocybin
Intervention: Drug: Psilocybin
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: January 17, 2021)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age of 20-70 years (both included).
  2. Body weight of 60-95 kg (both included).
  3. Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
  4. Alcohol Use Disorder Identification Test (AUDIT) ≥ 15.
  5. ≥ 5 heavy drinking days.

Exclusion Criteria:

  1. Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
  2. History of delirium tremens or alcohol withdrawal seizures.
  3. History of suicide attempt or present suicidal ideation.
  4. Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
  5. Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.
  6. Impaired hepatic function (liver transaminases > 3 times upper normal limit).
  7. Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
  8. Abnormal electrocardiogram
  9. Impaired renal function (eGFR < 50 ml/min).
  10. Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
  11. Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
  12. Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
  13. Any other active substance use defined as a Drug Use Disorder Identification Test score > 6/2 (m/w) and substance use disorder based on investigator's clinical evaluation, except for nicotine.
  14. Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective61.
  15. Hypersensitivity to the active substance or to any of the excipients.
  16. Unable to speak and/or understand Danish.
  17. Any condition that the investigator feels would 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: Anders Fink-Jensen, Professor +45 22755843 anders.fink-jensen@regionh.dk
Contact: Mathias E Jensen, MD +45 61634663 mathias.ebbesen.jensen.01@regionh.dk
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04718792
Other Study ID Numbers  ICMJE PSILO4ALCO-FEASIBILITY
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 Not Provided
Responsible Party Anders Fink-Jensen, MD, DMSci, Psychiatric Centre Rigshospitalet
Study Sponsor  ICMJE Anders Fink-Jensen, MD, DMSci
Collaborators  ICMJE The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
Investigators  ICMJE
Principal Investigator: Anders Fink-Jensen, Professor Professor
PRS Account Psychiatric Centre Rigshospitalet
Verification Date January 2021

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