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Psychedelic Agent

Psilocybin and Midazolam for 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

RECAP Trial Summary

This trial is designed to find the best dose of a drug that will allow someone to have a psychedelic experience while being unable to remember it. This is a necessary step for further study into whether or not psychedelic experiences can have antidepressant effects.

Eligible Conditions
  • Amnesia
  • Psychedelic Experiences

RECAP Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Accuracy on post-dosing Day 1 in recognizing ASC items asked during the dosing session Day 0 (number of correct versus distractor items)
Midazolam
Safety of psilocybin-midazolam co-administration assessed by number of participants leading to withdrawal from study due to adverse events
+4 more

RECAP 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

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,183 Previous Clinical Trials
3,167,963 Total Patients Enrolled
Christopher R Nicholas, MD,PHDPrincipal InvestigatorUniversity of Wisconsin Hospital and Clinics, Madison, Wisconsin, United State, 53715

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities to volunteer for this clinical investigation?

"Clinicaltrials.gov indicates that the trial, which was established on May 21st 2021 is not presently recruiting. However, there are still 104 other trials actively enrolling patients at this moment in time."

Answered by AI

What is the approximate size of the cohort involved in this research?

"At present, this clinical trial is not recruiting. The original post date was May 21st 2021 and the most recent update to the listing occurred on August 1st 2022. If you are seeking other trials, there are 7 amnesia trials currently enrolling patients as well as 97 studies involving Psilocybin and Midazolam that require participants."

Answered by AI

Has the FDA sanctioned Psilocybin and Midazolam for therapeutic use?

"Our team at Power rated the safety of Psilocybin and Midazolam a 1 as there is restricted evidence advocating for both efficacy and security, due to this being an early phase trial."

Answered by AI

Are individuals aged over 30 eligible to enrol in this experiment?

"This medical experiment only permits patients between the ages of 21 and 65 to be recruited. Fortunately, there are 25 trials taking place for individuals under 18 years old and 71 studies available for those beyond the age of retirement."

Answered by AI

To whom is enrollment into this medical study open?

"The recruitment criteria for this amnesia trial is as follows: 12 participants between 21-65 years of age, no DSM-5 psychiatric diagnosis and psychotropic medications in current use, willingness to participate in all study activities, contraceptive methods by sexually active males and women of childbearing potential, medically healthy with no exclusionary medical condition established and abstention from psychedelic drug consumption within the previous 3 months."

Answered by AI

What medical conditions are Psilocybin and Midazolam traditionally employed to address?

"Psilocybin and midazolam are both effective treatments for reducing anxiety, inducing amnesia, and managing convulsive status epilepticus."

Answered by AI

Who else is applying?

What state do they live in?
Washington
California
South Carolina
Other
How old are they?
18 - 65
What site did they apply to?
UWHealth, 600 Highland Avenue
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Pilot RECAP Study in Healthy Volunteers
2021. "Pilot RECAP Study in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04842045.
~2 spots leftby Apr 2025
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