Clinical trial NCT06692192: The RECAP2 Study: Midazolam and Psilocybin
Official title: Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Psilocybin
Keywords: sub-optimal wellbeing
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: Vail Health Foundation
First posted: 2024-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing.

Researchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing.

Participants will:

* Receive one of four possible combinations of medications
* Undergo an MRI
* Complete questionnaires
* Undergo transcranial magnetic stimulation (TMS) and EEG

Detailed description: The purpose of this study is to investigate the role that inducing neuroplasticity plays in the behavioral effects of psilocybin in people with modest decrements in emotional wellbeing.

Eligibility criteria: Inclusion Criteria:

* Age 18 to 70 years at screening, of any identified gender and racial/ethnic group
* Physically healthy; does not meet criteria for an exclusionary medical condition
* English-speaking (able to provide consent and complete questionnaires)
* Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder

Exclusion Criteria:

* Exclusionary DSM-5 psychiatric diagnosis and/or active suicidal ideation
* Exclusionary medical conditions
* Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)
* Clinically significant electrocardiogram (ECG)
* Use of psychotropic or CNS-altering medications within 3 months of screening
* Hypertension or tachycardia

Primary outcomes:
measure: Change in Penn Conditional Exclusion Test (PCET)
timeFrame: Baseline to 7 days post-dose
measure: Change in Warwick-Edinburgh Mental wellbeing Scale (WEMWBS)
timeFrame: Baseline to 7 days post-dose
measure: Change in Brief Experiential Avoidance Questionnaire (BEAQ)
timeFrame: Baseline to 7 days post-dose
measure: Change in transcranial magnetic stimulation evoked potential (TEP) amplitude
timeFrame: Baseline to 7 days post-dose
Secondary outcomes:
measure: PCET
timeFrame: 28 days post-dose
measure: BEAQ
timeFrame: 28 days post-dose
measure: Change in Personalized Psychological Flexibility Index (PPFI)
timeFrame: Baseline to 28 days post-dose
measure: Change in Alternate Use Task (AUT)
timeFrame: Baseline to 28 days post-dose
measure: Change in Cognitive Control and Flexibility (CCF) questionnaire
timeFrame: Baseline to 28 days post-dose
measure: Change in TEP amplitude
timeFrame: Baseline to 28 days post-dose
measure: Altered States of Consciousness (ASC) questionnaire
timeFrame: Dosing 1 day
measure: Emotional Breakthrough Inventory (EBI)
timeFrame: Dosing 1 day
measure: Psychological Insight Questionnaire (PIQ)
timeFrame: Dosing 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Charles Raison, MD
role: PRINCIPAL_INVESTIGATOR
References: