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Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• Age 18 to 65 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

• Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)

Locations
United States
Wisconsin
UW School of Medicine and Public Health
RECRUITING
Madison
Contact Information
Primary
RECAP Study Contact
recap2@psychiatry.wisc.edu
608-263-4852
Time Frame
Start Date: 2025-08-07
Estimated Completion Date: 2027-12
Participants
Target number of participants: 60
Treatments
Experimental: Group 1: Psilocybin and intravenous (IV) midazolam
Psilocybin (25 mg) + IV midazolam
Experimental: Group 2: Psilocybin and IV saline
Psilocybin (25 mg) + IV saline (placebo for midazolam)
Experimental: Group 3: Psilocybin and IV midazolam
Psilocybin (1 mg/control) + IV midazolam
Experimental: Group 4: Psilocybin and IV saline
Psilocybin (1 mg/control) + IV saline
Related Therapeutic Areas
Sponsors
Collaborators: Vail Health Foundation
Leads: University of Wisconsin, Madison

This content was sourced from clinicaltrials.gov