PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment
Johns Hopkins University
Summary
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
- Age range
- 21–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Adults aged 21 to 65 years old * Fluency in English * At least high school level of education * Right-handed * Female participants of childbearing potential must agree to use a highly effective method of contraception throughout the study. Highly effective methods are defined as those that, when used consistently and correctly (alone or in combination), are associated with a failure rate of less than 1% per year. Condoms alone are not considered highly effective. Abstinence is not considered a highly effective method. However, at the investigator's discretion, abstinence…
Interventions
- DrugPsilocybin
Psilocybin, 25 mg, oral, single dose
- DrugPimavanserin
Pimavanserin, 34 mg, oral, two doses
- DrugInactive Placebo
Inactive placebo, oral, two doses
Location
- Johns Hopkins Center for Psychedelic and Consciousness ResearchBaltimore, Maryland