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Psychedelic Agent

Psilocybin and Midazolam for Dissociative Amnesia (RECAP Trial)

Phase 1
Waitlist Available
Led By Christopher R Nicholas, MD,PHD
Research Sponsored by University of Wisconsin, Madison
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up on day 15
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a combination of psilocybin and midazolam in healthy volunteers to find the right dose of midazolam. Psilocybin creates a psychedelic experience, and midazolam causes temporary memory loss for it. The goal is to see if remembering the experience is needed for psilocybin's antidepressant effects.

Eligible Conditions
  • Dissociative Amnesia
  • Amnesia
  • Psychedelic Experiences

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~on day 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and on day 15 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of participants scoring < 50 percent on post-dosing Day 1 of the mean normative score of ASC data from healthy volunteers administered the ASC questionnaire post-dosing
Number of participants scoring >50 percent of normative scores on selected questions from the Altered States of Consciousness (ASC) questionnaire asked during the dosing session Day 0.
Secondary study objectives
Accuracy on post-dosing Day 1 in recognizing ASC items asked during the dosing session Day 0 (number of correct versus distractor items)
Midazolam

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment1 Intervention
Medically and psychiatrically healthy adults ages 21 to 65 years will receive a single 25 mg dose of psilocybin combined with repeated boluses of midazolam administered in a clinically supportive setting.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin and Midazolam
2021
Completed Phase 1
~10

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,231 Previous Clinical Trials
3,199,877 Total Patients Enrolled
Christopher R Nicholas, MD,PHDPrincipal InvestigatorUniversity of Wisconsin Hospital and Clinics, Madison, Wisconsin, United State, 53715
~2 spots leftby Dec 2025
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