Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

Assessment of the incidence and severity of expected and unexpected adverse events

Proportion of included patients who complete the planned procedures

Cmax: maximum concentration of plasma psilocin determined from concentrations-versus-time data. Blood samples will be drawn with intervals of 20 minutes

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

AUC: Area under the plasma concentrations-versus-time curve determined using the linear trapezoidal rule.

Acute and subacute changes in plasma and wholeblod brain-derived neurotropic factor (BDNF)

Acute and subacute changes in plasma cytokines including tumour necrosis factor alpha, interleukin-4 and 6.

Acute changes in systolic and diastolic blood pressure (mmHg)

Acute changes in heart rate (beats per minute)

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.

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.

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).

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.

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 heavy drinking day, defined as consuming 60/48 g (men/women) of alcohol or more on any day, in the past 28 days as quantified by the Timeline Followback Method

Change in drinks per day in the past 28 days as quantified by the Timeline Followback Method

Change in drinking days in the past 28 days as quantified by the Timeline Followback Method

Change in self-reported alcohol use measured by the Alcohol Use Identification Test (AUDIT). The AUDIT has 10 questions and the possible responses to each question are scored 0, 1, 2, 3 or 4, with the exception of questions 9 and 10 which have possible responses of 0, 2 and 4. The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcoho

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-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 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.

Change in self-reported flexibility measured by the Acceptance and Action Questionnaire (AAQ). The patients are asked to rate the items on a 7-point scale going from 1= Never true to 7= Always true.

Change in self-reported depression symptoms measured by the Major Depressive Inventory (MDI). The patients are asked to rate the items on a 6-point scale going from 1= Always to 7= Never.

Assessment of the patients expectations before the treatment as measured by the Stanford Expectations of Treatment Scale (SETS).

Assessment of eight categories of possible changes in attitudes, mood, social effects, and behavior after drug administration

Change in personality traits as measured by NEO Five-Factor Inventory-3 (NEO-FFI-3). NEO-FFI is 60 items measuring five dimensions of personality: Agreeableness (A), Conscientiousness (C), Neuroticism (N), Extraversion (E), and Openness to Experience (O)