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Healthy AdultsEarly Phase 1NCT07732166

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

A Early Phase 1 study testing Psilocybin (Usona Institute) and Niacin 100 mg in people with Healthy Adults, run by Pontifícia Universidade Católica do Rio de Janeiro at 1 site in Brazil.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Adults
What is being tested?
Psilocybin (Usona Institute) and Niacin 100 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteBrazil
Study dates
1 Apr 2026to 1 Dec 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Minimum age of 21 and maximum age of 60;
  • Minimum of eight years of schooling;
  • Fluency in Portuguese;
  • Agree, one week before the experiment, to abstain from:
  • Using any herbal supplements (except with prior approval from the researchers);
  • Using any non-prescribed medication (except non-steroidal anti-inflammatory drugs or paracetamol, provided they have prior approval from the research team);
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  • Using any prescribed medication (except birth control pills, thyroid hormones, or other medications, provided they have prior approval from the research team);
  • Using recreational psychoactive substances;
  • Agree to abstain, 24 hours before the experiment, from:
  • Consuming beverages with high caffeine content (e.g., coffee, mate, cola);
  • Consuming alcoholic beverages;
  • Agreeing not to use caffeine or nicotine for two and six hours, respectively, after the experiment;
  • Agree not to drive a motor vehicle or operate machinery for 24 hours after the experiment;
  • Be available to be contacted by telephone for all planned stages;
  • Agree to use effective contraception throughout the study;
  • Agree to inform researchers of any medical condition or procedure that may arise prior to the experiment;
  • Agree not to participate in any other interventional clinical trial for the duration of this study.

Who cannot join

  • History of traumatic brain injury, stroke, epilepsy, neurological disease, or cardiovascular disease;
  • Evidence or history of coronary or cerebral artery disease, peripheral vascular disease, liver disease with altered liver enzymes, or any other medical condition that the researchers, including the responsible physician, deem to significantly increase the risk of administering any substance;
  • Pregnant or breastfeeding women, or women who could potentially become pregnant and are not using any effective contraceptive method;
  • Women who, at the screening stage, do not have a negative pregnancy test.
  • Having a history of or currently having a primary psychotic disorder, schizophrenia spectrum disorder, bipolar affective disorder (type 1 and 2), dissociative identity disorder, major depressive disorder;
  • History of psychotic disorders in a first-degree relative;
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  • Have resting blood pressure that does not exceed 140 mmHg (systolic) and 90 mmHg (diastolic) - measured in four assessments on at least two different days;
  • Have resting blood pressure below 90 mmHg (systolic) and 60 mmHg (diastolic) - measured in four assessments on at least two different days;
  • Weigh less than 48 kg;
  • Require therapy with psychiatric medications concurrently with the study;
  • Have a history of or present with gastrointestinal disease;
  • Previous use of psilocybin or similar substances;
  • Frequent use (at least once a month) of any other psychoactive substance in the last year, except for nicotine, caffeine and alcohol;
  • Have a history of disorders or problems related to the use of psychoactive substances;
  • Not be able to provide adequate informed consent;
  • Any other condition that may compromise the results or that represents any risk to the participant, according to the assessment of the research team and the responsible physician.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel C Mograbi, PhD contact

+ 55 21 35272505

mograbilab@gmail.com

Brazil1 site, 1 recruiting
  • Centro de Pesquisas Matteo Ricci

    Rio de Janeiro, Rio de Janeiro, 22451-263

    Mograbi, + 55 21 35272505, mograbilab@gmail.com

    Recruiting

Other trials in Brazil

About this study

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.

Conditions
Healthy Adults
Being tested
Psilocybin (Usona Institute), Niacin 100 mg
Keywords
Psilocybin, Self-awareness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Psilocybin (Usona Institute)Drug

    3x 5mg capsules of Psilocybin (cGMP)

  • Niacin 100 mgDrug

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

Study groups in NCT07732166
Study groupRoleWhat they receive
Psilocybin (15 mg)ExperimentalNot described
Receives: Drug: Psilocybin (Usona Institute)
Niacin (100mg)Sham comparatorNot described
Receives: Drug: Niacin 100 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in global metacognitive judgment using the Computerized Success-Failure Manipulation Paradigm.

    The success-failure manipulation (SFM) task is a computerized paradigm designed to study metacognition. After a practice phase, the task uses a titration procedure to establish each participant's reaction-time threshold. In the experimental phase, the program presents trials above or below this threshold to systematically induce controlled failure or success states. Participants are asked to estimate the percentage of trials they have succeeded in. The paradigm allows precise experimental control over actual performance, enabling direct comparisons of metacognitive abilities under identical conditions. More information can be found at: http://www.redalyc.org/articulo.oa?id=513751529005

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session).

Secondary outcomes (12)
  1. Changes in the Multidimensional Assessment of Interoceptive Awareness (MAIA)

    The Multidimensional Assessment of Interoceptive Awareness (MAIA) is a 32-item self-report questionnaire designed to measure multidimensional interoceptive body awareness across eight distinct subscales: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. Respondents rate items on a 6-point Likert scale ranging from 0 ("never") to 5 ("always"). Subscale scores are calculated as the average of their respective items, with higher scores reflecting greater interoceptive awareness and adaptive body focus. The instrument evaluates how individuals perceive, process, and regulate internal bodily sensations. The total cumulative raw score across all items ranges from 0 to 160. Higher average scores reflect a greater and more mindful degree of interoceptive awareness. More information at https://doi.org/10.1371/journal.pone.0048230

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session)

  2. Changes in the Emotional Regulation Questionnaire (ERQ)

    The Emotion Regulation Questionnaire (ERQ) is a 10-item self-report scale designed to assess individual differences in two widely used emotion regulation strategies: Cognitive Reappraisal (6 items) and Expressive Suppression (4 items). Respondents rate statements on a 7-point Likert scale ranging from 1 ("strongly disagree") to 7 ("strongly agree"). Subscale scores are calculated by averaging the items corresponding to each strategy, with higher scores reflecting a greater, more habitual reliance on that specific emotional regulation strategy. More information at: https://pubmed.ncbi.nlm.nih.gov/12916575/

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session)

  3. Changes in the Toronto Alexithymia Scale (TAS)

    The TAS is a 20-item, self-administered questionnaire that measures difficulty in identifying and describing emotions (alexithymia) across three subscales: Difficulty Identifying Feelings (DIF, 7 items), Difficulty Describing Feelings (DDF, 5 items), and Externally-Oriented Thinking (EOT, 8 items). Respondents rate items on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"), with five items negatively keyed. Total scores are calculated by summing item responses, with higher overall and subscale scores indicating greater difficulty with emotional processing, awareness, and expression. The instrument evaluates individual deficits in recognizing, articulating, and reflecting on emotional states. More information at: https://doi.org/10.1016/0022-3999(94)90005-1

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session)

  4. Changes in the Ruminative Response Scale-short form

    The 10-item Ruminative Response Scale (RRS-10) is a brief self-report questionnaire designed to assess repetitive, depressive rumination without confounding items related to depressive symptoms. It evaluates two distinct subscales with 5 items each: Brooding (a passive, maladaptive focus on unachieved standards) and Reflection (a purposeful, adaptive engagement in cognitive problem-solving). Respondents rate statements on a 4-point Likert scale ranging from 1 ("almost never") to 4 ("almost always"). Subscale and total scores are calculated by summing or averaging the respective item responses, with higher scores reflecting a greater frequency of ruminative thought patterns. More information at: doi.org/10.1007/978-3-030-77644-2_84-1

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session)

  5. Ego Dissolution Inventory (EDI) Score

    Self-report questionnaire designed to measure ego-dissolution-the temporary breakdown or loss of a distinct sense of self and personal identity. Uses an 8-item scale rated on a visual analog scale (VAS) from 0 to 100. 0 means "No, not more than usual" and 100 means "Yes, I experienced this completely/entirely". Total Score is calculated as the mean of all eight items, yielding an overall score from 0 to 100 that represents the strength of the experience. More information at: https://pubmed.ncbi.nlm.nih.gov/27378878/

    Measured: Immediately after the dosing session (4 hours after intake)

  6. Altered States of Consciousness Rating Scale (OAV) Score

    Self-report questionnaire used to measure subjective experiences during non-ordinary states of consciousness. It evaluates three core dimensions: Oceanic Boundlessness, Dread of Ego Dissolution, and Visionary Restructuralization. It contains 66 items rated on a continuous line or numerical scale (0 to 100), from "No, not more than usual" (0) to "Yes, much more than usual" (100). Higher scores mean a greater intensity of subjective changes during an experience for each dimension. More information at: https://doi.org/10.1371/journal.pone.0012412

    Measured: Immediately after the dosing session (4 hours after intake)

  7. Changes in Interoceptive Accuracy and Awareness, measured by a Heartbeat Discrimination Task

    In this task, participants silently count their felt heartbeats within randomized time windows of 25 to 50 seconds, without manually checking their pulse. Actual heartbeats are measured with an electrocardiogram (ECG). Participants are also asked how confident they feel about their estimates. These responses are then used to quantify metacognitive interoceptive awareness by correlating confidence with actual performance accuracy. More information can be found at: http://dx.doi.org/10.1016/j.biopsycho.2014.11.004

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session)

  8. Changes in Sense of Agency, measured by an Intentional Binding paradigm

    This task measures explicit sense of agency (SoA) through a retrospective judgment of self-authorship, where participants rate their perceived control over a sensory event triggered by their action, and implicit SoA via "intentional binding," which assesses the compression of subjective temporal intervals between a voluntary motor action and its sensory effect. The task derives two primary scores: an explicit Agency Rating Score obtained from a 9-point Likert scale (ranging from 1 for "not at all" to 9 for "extremely strongly"), and an implicit Intentional Binding Score calculated as an estimation ratio of subjective interval durations between baseline (passive) and active tasks. More details can be found at: https://doi.org/10.1016/j.concog.2018.11.005.

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session)

  9. Changes in the Spontaneous Sensations Task

    The Spontaneous Sensations Task is a standard behavioral method for evaluating body awareness by measuring sensations in the absence of external triggers. Participants rest one hand palm-up on a white fabric and focus their direct gaze on it for 10 seconds. Immediately after, they must report any detected sensations on a standardized hand map, specifying their location, extent, intensity (1-10 scale), confidence level, and sensory descriptors. More details can be found at: https://doi.org/10.1080/08990220.2021.1914018

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session)

  10. Changes in an Online Paradigm of Self-reference Effect

    The online self-referential encoding paradigm assesses memory enhancement driven by self-related concepts. The task evaluates how information is systematically processed and retained when encoded in relation to the self versus structural or semantic controls. During the encoding phase, participants answer specific questions about single-trait adjectives (e.g., "Does this word describe yourself?"). The task measures memory performance through an incidental free-recall activity or a recognition format administered after a short filler task. More information can be found at: https://doi.org/10.1371/journal.pone.0176611

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session)

  11. Changes in the Eriksen Flanker Task adapted to measure Sense of Agency

    To assess the prospective contribution of action selection to the sense of agency, participants perform the Eriksen flanker task, in which they respond to a central target letter flanked by supraliminal stimuli that are congruent, neutral, or incongruent. Correct responses trigger the appearance of a colored circle after a variable delay, and participants judge their level of control over the color. The protocol evaluates how conflict in action selection affects agency ratings, more specifically, whether dysfluency reduces the perceived sense of control. More information ca be found at: http://dx.doi.org/10.1016/j.actpsy.2016.03.003

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session)

  12. Changes in Proprioceptive Information Processing measured by a Mirror-induced Bias Paradigm

    This task measures the integration of visual and proprioceptive information regarding hand location using a mirror along the midsagittal plane. Participants perform reaching movements to a target with their unseen hand behind the mirror under different conditions of exposure to the mirror-reflected hand. The task evaluates how spatial congruence between visual and real hand positions affects reach accuracy, as visual conflicts can significantly bias reaching movements. The goal is to determine how multisensory conflict affects the visual recalibration of proprioception. More information can be found at: doi.org/10.1007/s00221-005-2389-4

    Measured: From baseline (one week before the dosing session) to follow up (one week after the dosing session)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2026
  2. Study start1 Apr 2026
  3. Primary completion1 Aug 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Crossover
Model description
Participants allocated to the placebo group are invited to an open-label extension phase, upon availability of the substances.
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07732166
Sponsor's protocol ID
54547221.1.0000.5263
Status last verified
Jul 2026
First submitted
21 Jul 2026
Last updated
28 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Lage CA, Wolmarans W, Mograbi DC. An evolutionary view of self-awareness. Behav Processes. 2022 Jan;194:104543. doi: 10.1016/j.beproc.2021.104543. Epub 2021 Nov 17.

    PubMed 34800608
  • Bienemann B, Barbosa AR, Cruz LVMD, Multedo M, Mograbi D. Health Benefits and Positive Acute Effects of Psilocybin Consumption: A Quantitative Textual Analysis of User Self-Reported Data. J Psychoactive Drugs. 2024 Jul-Aug;56(3):324-332. doi: 10.1080/02791072.2023.2226414. Epub 2023 Jun 22.

    PubMed 37348116
  • Mograbi DC, Hall S, Arantes B, Huntley J. The cognitive neuroscience of self-awareness: Current framework, clinical implications, and future research directions. Wiley Interdiscip Rev Cogn Sci. 2024 Mar-Apr;15(2):e1670. doi: 10.1002/wcs.1670. Epub 2023 Dec 3.

    PubMed 38043919
  • Bienemann B, Longo MSC, Ridolfi M, Multedo M, Cruz LVM, Schenberg E, Tofoli LF, Mograbi DC. Adaptation and latent structure of the Brazilian version of the Ego Dissolution Inventory (EDI-BR): an exploratory study. Trends Psychiatry Psychother. 2024;46:e20220491. doi: 10.47626/2237-6089-2022-0491. Epub 2022 Oct 18.

    PubMed 36283045
  • Mograbi DC, Rodrigues R, Bienemann B, Huntley J. Brain Networks, Neurotransmitters and Psychedelics: Towards a Neurochemistry of Self-Awareness. Curr Neurol Neurosci Rep. 2024 Aug;24(8):323-340. doi: 10.1007/s11910-024-01353-y. Epub 2024 Jul 9.

    PubMed 38980658
  • Rodrigues RS, Wiessner I, Daldegan-Bueno D, Bienemann B, Pontual A, Tofoli LF, Mograbi DC. OAV and 5D-ASC for Brazilian Portuguese: A validation and adaptation study. J Psychopharmacol. 2025 Sep;39(9):990-1006. doi: 10.1177/02698811251344685. Epub 2025 Jun 28.

    PubMed 40579992

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Psilocybin (Usona Institute) and Niacin 100 mg in people with Healthy Adults, run by Pontifícia Universidade Católica do Rio de Janeiro at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel C Mograbi, PhD (+ 55 21 35272505, mograbilab@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in global metacognitive judgment using the Computerized Success-Failure Manipulation Paradigm. (time frame: From baseline (one week before the dosing session) to follow up (one week after the dosing session).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07732166, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.

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