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NCT04842045 · ClinicalTrials.gov registry record · Phase 1
Pilot RECAP Study in Healthy Volunteers
A Phase 1 study of Psychedelic Experiences and Amnesia, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
- 1
- Study location
NCT04842045: Completed Phase 1 study of Psychedelic Experiences and Amnesia, sponsored by University of Wisconsin, Madison.
NCT04842045 is a Phase 1 study of Psychedelic Experiences and Amnesia that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 8 participants, below the 39-participant average among 4 other Psychedelic Experiences trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04842045, a Phase 1 study of Psychedelic Experiences and Amnesia, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experience to occur while inducing amnesia for the experience. This is an essential step required for subsequent evaluation of the role of memory for the psychedelic experience in the antidepressant effects of psilocybin in the full RECAP study.
Primary Outcome
Participants will complete a selection of several questions from the ASC questionnaire that strongly associate positively or negatively with later antidepressant effect of psilocybin in patients with treatment resistant depression or capture classic features of the psychedelic experience. During the dosing session, investigator will repeatedly ask selected items from the ASC scale to get a "real time" measure of what the participants are experiencing. Each of these items will be scored separate
Conditions Studied
Interventions
- DRUG Psilocybin and Midazolam
Study Locations (1)
Wisconsin
- UWHealth, 600 Highland Avenue - Madison
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2021-05-21 |
| Est. Completion | 2022-11-17 |
| Phase | Phase 1 |
What the finished NCT04842045 record still lists
NCT04842045 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 39-participant average among 4 other Psychedelic Experiences trials with a reported enrollment target (79% lower).
The record links to 2 conditions, with Psychedelic Experiences appearing as the primary indexed condition, and to 1 intervention - of which Psilocybin and Midazolam is the first listed.
NCT04842045 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04842045 about?
NCT04842045 is a clinical study titled "Pilot RECAP Study in Healthy Volunteers". The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin. This pilot dosing study (PILOT RECAP) is designed to determine the optimal dose of midazolam that allows a psychedelic experie...
What is the current status of trial NCT04842045?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2021-05-21. Estimated completion is 2022-11-17.
What conditions does trial NCT04842045 study?
This clinical trial studies the following conditions: Psychedelic Experiences, Amnesia.
What interventions are being tested in trial NCT04842045?
The interventions under investigation include: Psilocybin and Midazolam (DRUG).
Who is sponsoring clinical trial NCT04842045?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04842045 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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