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NCT05698511 · ClinicalTrials.gov registry record · Phase 1
Neural and Physiological Correlates of Psychedelic Sub-states
A Phase 1 study of Healthy Volunteers and Psychedelic Experiences, sponsored by Robin Carhart-Harris, PhD, MA.
- Active
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT05698511 is a Phase 1 study of Healthy Volunteers and Psychedelic Experiences that is active but no longer recruiting, run by Robin Carhart-Harris, PhD, MA. The registered enrollment target is 12 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05698511, a Phase 1 study of Healthy Volunteers and Psychedelic Experiences, is active but no longer recruiting, sponsored by Robin Carhart-Harris, PhD, MA.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The main purpose of this study is to gain a better understanding of the distinct mental states and physical reactions that can arise during a psychedelic experience. By repeatedly assessing the same participants in an MRI while under the effects of psilocybin, the investigators want to identify reliable brain and body reactions arising during these psychedelic experiences. It is hoped that this will provide an insight to inspire future research on psilocybin and related psychedelics as well as inform on their therapeutic action. This study will involve up to 12 healthy volunteers with previous psychedelic experience. Participants in this study will be given four doses of psilocybin, with breaks of at least seven days in between dosing visits. The first dosing visit will feature a 10 mg dose of psilocybin, which can be considerate a low to moderate dose, whereas the remaining three dosing visits will feature 25 mg psilocybin, a high dose that is consistent with the dosage chosen for several modern clinical trials with psilocybin. From the initial in-person screening visit to the final follow-up, participants will be in this study for approximately 6-12 weeks and visit the research site 5 times. The first visit will be an in-person screening visit, during which the investigators will assess participants' eligibility to be enrolled. There will be 4 subsequent visits to the scan center for dosing and magnetic resonance imaging (MRI) scanning, and there will be a final remote follow up. Each of the four dosing visits will include four periods of lying within the MRI scanner for scanning, each of these 'in-scanner' sessions will last for \~ 45 minutes. Actual scans, which are also called 'runs' last for \~ 12 mins. During these 'runs', the investigators will ask participants two brief questions about how positive or negative their current experience is every 100 seconds. They will be able to record their answers using a button box which they will be operating with their h
Conditions Studied
Interventions
- DRUG Psilocybin
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-07-31 |
| Est. Completion | 2026-01-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05698511
The ClinicalTrials.gov registry entry for NCT05698511 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (98% lower). The listed sponsor is Robin Carhart-Harris, PhD, MA, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Psilocybin is the first listed.
NCT05698511 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT05698511 about?
NCT05698511 is a clinical study titled "Neural and Physiological Correlates of Psychedelic Sub-states". The main purpose of this study is to gain a better understanding of the distinct mental states and physical reactions that can arise during a psychedelic experience. By repeatedly assessing the same participants in an MRI while under the effects of psilocybin, the investigators want to identify reli...
What is the current status of trial NCT05698511?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2023-07-31. Estimated completion is 2026-01-30.
What conditions does trial NCT05698511 study?
This clinical trial studies the following conditions: Healthy Volunteers, Psychedelic Experiences, Neuroimaging.
What interventions are being tested in trial NCT05698511?
The interventions under investigation include: Psilocybin (DRUG).
Who is sponsoring clinical trial NCT05698511?
This trial is sponsored by Robin Carhart-Harris, PhD, MA, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05698511 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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