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Table 1 Schedule of key study activities

From: Psilocybin-assisted therapy for severe alcohol use disorder: protocol for a double-blind, randomized, placebo-controlled, 7-month parallel-group phase II superiority trial

 

Screening

Baseline

Preparation 1

Preparation 2

Dosing

Integration 1

Integration 2

4-week endpoint

6-month follow-up

Days relative to dosing

 

-20

-7

-1

0

+ 1

+ 7

+ 35

+ 190

Key assessments

         

Informed consent

X

        

Psychiatric screening

X

        

Physical screening

X

        

Key outcomes

         

Clinical outcomes

         

Heavy drinking

 

X

     

X

X

Drinking days

 

X

     

X

X

Abstinence

 

X

     

X

X

PEth

       

X

 

Mood

 

X

 

X

  

X

X

X

Anxiety

 

X

 

X

  

X

X

X

Trauma

 

X

 

X

  

X

X

X

Global functioning

 

X

     

X

X

Safety

         

Adverse events

 

X

X

X

X

X

X

X

X

Feasibility

         

Insclusion rates

X

        

Retention rates

  

X

X

X

X

X

X

X

Neurocog. outcomes

         

Neuroplasticity (LTP)

  

X

  

X

X

  

Cue reactivity

  

X

  

X

X

  

Inhibition

  

X

  

X

X

  

Drug experience

         

Mystical (MEQ)

    

X

    

Acceptance/Avoidance (APEQ)

    

X

    

Trauma access/process.

(Helioscope Q.)

    

X

    

Psychological processes

         

Flexibility (AAQQ II)

 

X

 

X

  

X

X

X

Interoception (MAIA)

 

X

 

X

  

X

X

X

Connectedness (WCS)

 

X

 

X

  

X

X

X

Alcohol-related parameters

         

Craving (PACS)

 

X

 

X

  

X

X

X

Abstinence self-efficacy (AASE)

 

X

 

X

  

X

X

X

Readiness to change

 

X

 

X

  

X

X

X

  1. Abbreviations: PEth Phosphatidylethanol, LTP Long-term potentiation, MEQ Mystical Experience Scale, APEQ Acceptance/Avoidance-Promoting Experiences Questionnaire, AAQ-II Acceptance and Action Questionnaire Version 2, MAIA Multidimensional Assessment of Interoceptive Awareness, WCS Watts Connectedness Scale, PACS Penn Alcohol Craving Scale, AASE Alcohol Abstinence Self-Efficacy Scale