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Psilocybin Efficacy With or Without Pimavanserin Pretreatment

ConditionsMood (Psychological Function)Well BeingMoodHealthy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age21-65
SponsorJohns Hopkins University

About this trial

Twenty healthy adults (≥21 years old) will be enrolled to evaluate the efficacy of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or placebo. Outcome assessments will occur at 1 week and 1 month following psilocybin administration.

The purpose of this study is to clarify the receptor-level mechanisms underlying psilocybin's effects on mood and well-being, along with the associated neurophysiologic signatures. These mechanisms will be examined using psychometric scales, autonomic and fMRI-based neurophysiologic markers, and integrated pharmacokinetic/pharmacodynamic modeling.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 21 to 65 years old

Provision of written informed consent

Fluency in English

At least high school level of education

Disqualifiers

Non-English speakers and those with language or hearing impairments

Left-handedness (assessed by the Edinburgh Handedness Inventory)

Any lifetime history of psychedelic use, including serotonergic compounds (e.g., psilocybin, LSD, mescaline, DMT, 5-MeO-DMT) and nontraditional psychedelics (e.g., MDMA, ketamine, ibogaine)

History of psychiatric diagnosis in adulthood (≥18 years), including, but not limited to, major depressive disorder, bipolar disorder I and II, psychotic disorders, and substance use disorder.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Psilocybin

    Drug

    Psilocybin, 25 mg, oral, single dose

  • Pimavanserin

    Drug

    Pimavanserin, 34 mg, oral, two doses

  • Inactive Placebo

    Drug

    Inactive placebo, oral, two doses

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Psilocybin + PimavanserinExperimental treatment 2 interventions
Group B: Psilocybin + PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Persisting Effects Questionnaire (PEQ) score

Persisting effects will be assessed using the single item well-being item from the Persisting Effects Questionnaire (PEQ) at 1-week (primary inferential contrast) and 1-month post-dosing. The PEQ is an instrument designed to measure participants' retrospective attributions regarding the longer-term impact of the psilocybin experience, including effects on mood, behavior, and overall well-being. The item is rated on a 7-point Likert scale (-3 = decreased very much; -2 = decreased moderately; -1 = decreased slightly; 0 = no change; 1 = increased slightly; 2 = increased moderately; 3 = increased very much). Score range -3 to 3.

Time frame
Day 7, Day 30

Secondary outcomes

1

Amygdala Response to Stimuli in the Emotion Recognition Test

Blood oxygenation level-dependent (BOLD) percent signal change in response to stimuli in the emotion recognition task will be measured in the left and right amygdala.

Time frame
Day -1 (baseline), Day 7, Day 30
2

Pharmacokinetics (PK) of Psilocybin metabolites

PK parameter (AUC 0-6h) for unconjugated psilocin in plasma.

Time frame
0-6 hours

Other outcomes

Sponsors and contacts

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Johns Hopkins University

Lead sponsor

Source ClinicalTrials.gov
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