Health TrialsbyHealthPanel

Pilot Study on the Effects of Psilocybin on Belief Updating and Insight Formation

ConditionPhase I
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrown University

About this trial

The primary aim of this phase I mechanistic pilot study is to evaluate the effects of psilocybin on aspects of cognition in healthy adult volunteers. Up to 24 participants will receive a single dose of either psilocybin or inert placebo, and they will be asked to complete several computer-based behavioral tasks measuring features of learning, belief updating, and abstraction. Participants will also complete measures of subjective experience and expectancy, as well as semi-structured interviews at follow up, to assess whether experience correlates with behavior. This is a Voluntary Submission.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

be at least 18 years old at time of signing informed consent

be fluent in speaking and reading English

be able to swallow pills (capsules)

agree to use highly effective birth control for at least one month prior to enrollment, and for the duration of study enrollment, whether male or female assigned at birth. Acceptable methods include: copper or hormonal coil intrauterine device (IUD), implanted or injected hormonal method, documented permanent sterilization, documented not able to become pregnant, or oral/intravaginal/transdermal hormones plus a barrier contraception. Two forms of contraception are required with any barrier method or with any oral, intravaginal, or transdermal hormonal method due to these methods not being considered highly effective alone. Abstinence alone is not an acceptable contraceptive method for this study.

Disqualifiers

have used any psychedelic, hallucinogen, or entactogen, including 3,4-methylenedioxymethamphetamine (MDMA) and ketamine/esketamine, but not including cannabis, within the past 3 months

unwilling or unable to stop using cannabis a minimum of one week prior to enrollment and to refrain from cannabis use for the duration of the study enrollment, to be tested with urine drug screens

currently pregnant (as indicated by a positive urine pregnancy test assessed at intake and before the drug session), nursing, intending to become pregnant within 3 months of enrollment, intending to father a child within 3 months of enrollment, intending to donate sperm or eggs within 3 months of enrollment, or not practicing a highly effective means of birth control as noted in the Inclusion Criteria.

history of traumatic brain injury, or history of seizure disorder in adulthood

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin (Usona Institute)

    Drug

    1 dose of psilocybin 25 mg oral capsule

  • Inactive Placebo (Usona Institute)

    Drug

    1 dose of Microcrystalline Cellulose (MCC) 25 mg capsule

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: PsilocybinExperimental treatment 1 intervention
Group B: Inert PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Reinforcement Learning and Abstraction Task

Custom computer-based behavioral task requiring participants to complete a series of puzzles to complete game levels. This task requires working memory and reinforcement learning, and it also includes a measure of state abstraction.

Time frame
During dosing session and 1 day after the dosing session
2

Belief Updating Task

Custom computer-based behavioral task in which participants must dynamically adjust predictions on each trial. This task measures trial to trial belief updating.

Time frame
1 day before dosing, during dosing, and 1 day after the dosing session

Secondary outcomes

1

Altered States of Consciousness Questionnaire (ASC)

Measure of subjective experience.

Time frame
During dosing session
2

Mystical Experience Questionnaire (MEQ)

Measure of mystical type experiences

Time frame
During dosing session
3

Psychological Insight Questionnaire (PIQ)

Measure of psychological insight

Time frame
During dosing session
4

Emotional Breakthrough Inventory (EBI)

Measure of emotional breakthrough

Time frame
During dosing session

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brown University

Lead sponsor

Source ClinicalTrials.gov
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