RecruitingEarly Phase 1NCT07732166

Changes in Self-awareness Induced by Psychoactive Substances: an Experimental Study With Psilocybin.


Sponsor

Pontifícia Universidade Católica do Rio de Janeiro

Enrollment

100 participants

Start Date

Apr 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

Self-awareness, the capacity of becoming the object of one's own awareness, is a frontier of scientific knowledge. Over centuries, distinct philosophical and religious traditions have grappled with the subject, but only recently has the importance of self-awareness been established as a central concept for scientific investigation, to which scientific methods can be applied to explore and characterize this phenomenon. Self-awareness has important implications, notably from a clinical perspective. Psychedelics can affect the sense of self, with 'ego dissolution' being an essential feature of the experience of substances such as psilocybin and dimethyltryptamine. Recent evidence indicates that psychedelics can rearrange brain connectivity, with these changes being linked to alterations in self-awareness. Nevertheless, the extent to which specific components of self-awareness are modified by these substances has not been fully explored. It is possible that part of the clinical benefits of psychedelics, for conditions such as depression, OCD, and anxiety, is mediated by changes in self-awareness. Given this clinical potential, the current study aims to examine the effects of psilocybin on various components of self-awareness in healthy participants. 100 participants will be allocated to receive either 15mg of psilocybin (n=50) or an active placebo (100mg niacin; n=50). Participants will be assessed one week before, immediately after, and one week after the administration of the substances, performing tasks and completing questionnaires measuring self-awareness at these time points. The neural correlates of self-awareness, before and after substance effects, will be investigated using near-infrared spectroscopy. Participants allocated to the placebo group will be invited to an open-label extension with psilocybin upon availability of the substance. It is expected that the results of the study will elucidate the brain regions involved in self-awareness, as well as the alterations induced by psilocybin in this process, opening the possibility of new therapeutic interventions for different clinical groups.


Eligibility

Min Age: 21 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Niacin 100 mg and a drug called Psilocybin (Usona Institute) for people with healthy adults. The study is currently recruiting participants at 1 location. People eligible for this study include aged 21 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPsilocybin (Usona Institute)

3x 5mg capsules of Psilocybin (cGMP)

DRUGNiacin 100 mg

1x capsule 100mg Niacin (cGMP) + 2x 25mg Capsules of MCC Inert Placebo


Locations(1)

Centro de Pesquisas Matteo Ricci

Rio de Janeiro, Rio de Janeiro, Brazil

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NCT07732166


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