Back to resultsPsilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
Primary Purpose
Alcohol Use Disorder (AUD)
Status
Active
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Psilocybin
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder (AUD) focused on measuring psilocybin, alcohol use disorder, psychedelics, addiction, pharmacokinetics, psilocin, feasibility
Eligibility Criteria
Inclusion Criteria:
- Age of 20-70 years (both included).
- Body weight of 60-95 kg (both included).
- Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
- Alcohol Use Disorder Identification Test (AUDIT) ≥ 15.
- ≥ 5 heavy drinking days.
Exclusion Criteria:
- Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
- History of delirium tremens or alcohol withdrawal seizures.
- History of suicide attempt or present suicidal ideation.
- Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
- Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.
- Impaired hepatic function (liver transaminases > 3 times upper normal limit).
- Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
- Abnormal electrocardiogram
- Impaired renal function (eGFR < 50 ml/min).
- Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
- Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
- Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
- 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.
- Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective61.
- Hypersensitivity to the active substance or to any of the excipients.
- Unable to speak and/or understand Danish.
- Any condition that the investigator feels would interfere with trial participation.
Sites / Locations
- Psychiatric Center Copenhagen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Psilocybin
Arm Description
10 patients will receive a single administration of psilocybin
Outcomes
Primary Outcome Measures
Safety: Adverse events associated with administration of psilocybin in patients diagnosed with alcohol use disorder
Assessment of the incidence and severity of expected and unexpected adverse events
Secondary Outcome Measures
Feasibility: Proportion of participants who complete
Proportion of included patients who complete the planned procedures
Pharmacokinetic parameter of psilocin: Cmax
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
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
AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.
Subjective effects of psilocybin: Intensity
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
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
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
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
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
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
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
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.
Full Information
NCT ID
NCT04718792
First Posted
January 8, 2021
Last Updated
July 5, 2023
Sponsor
Anders Fink-Jensen, MD, DMSci
Collaborators
The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
1. Study Identification
Unique Protocol Identification Number
NCT04718792
Brief Title
Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
Official Title
Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
June 21, 2024 (Anticipated)
Study Completion Date
June 21, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Anders Fink-Jensen, MD, DMSci
Collaborators
The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder (AUD)
Keywords
psilocybin, alcohol use disorder, psychedelics, addiction, pharmacokinetics, psilocin, feasibility
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Open label study
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psilocybin
Arm Type
Experimental
Arm Description
10 patients will receive a single administration of psilocybin
Intervention Type
Drug
Intervention Name(s)
Psilocybin
Intervention Description
A single administration psilocybin (25mg, opaque capsule for oral ingestion). The psilocybin is synthetically manufactured under current Good Manufacturing Practices (cGMP)
Primary Outcome Measure Information:
Title
Safety: Adverse events associated with administration of psilocybin in patients diagnosed with alcohol use disorder
Description
Assessment of the incidence and severity of expected and unexpected adverse events
Time Frame
1 week after drug administration
Secondary Outcome Measure Information:
Title
Feasibility: Proportion of participants who complete
Description
Proportion of included patients who complete the planned procedures
Time Frame
1 week after drug administration
Title
Pharmacokinetic parameter of psilocin: Cmax
Description
Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data. Blood samples will be drawn with intervals of 20 minutes
Time Frame
From drug administration and 300 minutes after.
Title
Pharmacokinetic parameter of psilocin: Tmax
Description
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
Time Frame
From drug administration to 300 minutes after.
Title
Pharmacokinetic parameter of psilocin: AUC
Description
AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.
Time Frame
From drug administration to 300 minutes after.
Title
Subjective effects of psilocybin: Intensity
Description
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.
Time Frame
From drug administration to 8 hours after
Title
Subjective effects of psilocybin: Mystical Experience
Description
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.
Time Frame
8 hours after drug administration
Title
Subjective effects of psilocybin: Altered States of Consciousness
Description
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).
Time Frame
8 hours after drug administration
Title
Subjective effects of psilocybin: Awe Experience
Description
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.
Time Frame
8 hours after drug administration
Title
Subjective effects of psilocybin: Ego Dissolution
Description
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).
Time Frame
8 hours after drug administration
Title
Change in craving
Description
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.
Time Frame
Baseline and 1 week after drug administration
Title
Change in self-efficacy
Description
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.
Time Frame
Baseline and 1 week after drug administration
Title
Change in mindfulness
Description
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.
Time Frame
Baseline and 1 week after drug administration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age of 20-70 years (both included).
Body weight of 60-95 kg (both included).
Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
Alcohol Use Disorder Identification Test (AUDIT) ≥ 15.
≥ 5 heavy drinking days.
Exclusion Criteria:
Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
History of delirium tremens or alcohol withdrawal seizures.
History of suicide attempt or present suicidal ideation.
Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.
Impaired hepatic function (liver transaminases > 3 times upper normal limit).
Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
Abnormal electrocardiogram
Impaired renal function (eGFR < 50 ml/min).
Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).
Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
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.
Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective61.
Hypersensitivity to the active substance or to any of the excipients.
Unable to speak and/or understand Danish.
Any condition that the investigator feels would interfere with trial participation.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Fink-Jensen, Professor
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychiatric Center Copenhagen
City
Copenhagen
State/Province
Frederiksberg
ZIP/Postal Code
2000
Country
Denmark
12. IPD Sharing Statement
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Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
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