Phase 1 / Phase 2: testing Psilocybin for Mood (Psychological Function)
Twenty healthy adults (≥21 years old) will be enrolled to measure the how well it works of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or dummy treatment (placebo). Outcome assessments will occur at 1 week and 1 month following psilocybin administration.
Official registry: https://clinicaltrials.gov/study/NCT07610135 · Johns Hopkins University · enrollment listed as 20
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Psilocybin, Pimavanserin, or Inactive Placebo. The registry lists allocation as randomized. Twenty healthy adults (≥21 years old) will be enrolled to measure the how well it works of a single oral dose of psilocybin (25 mg) administered with or without pretreatment using oral pimavanserin (34 mg) or dummy treatment (placebo).
They plan to enroll about 20 people at Baltimore. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
PRISMatic: A Phase 1b Randomized, Double-Armed, Parallel-Group, Placebo-Controlled Trial of Psilocybin Efficacy With or Without Pimavanserin Pretreatment
Interventions: Psilocybin, Pimavanserin, Inactive Placebo
Primary outcome (registry wording): Persisting Effects Questionnaire (PEQ) score
Who it is for (from inclusion criteria)
- Ages 21 Years to 65 Years
- Age 21 to 65 years old
- At least high school level of education
- Agree to abstain from any psychoactive drugs on the day prior to and the day of the drug administration session as demonstrated by a negative toxicology report
- Agree not to take any PRN medications on the mornings of drug sessions
- 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
Who the registry excludes
- 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
- Current use of neuropsychiatric medications, including but not limited to typical/atypical antidepressants, antipsychotics, and stimulants
- Lifetime history of substance use disorder
- Current (within past six months) substance use disorder of moderate or greater severity
Public study contact (from the registry)
Arozo Azimi
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
1 listed- Johns Hopkins Center for Psychedelic and Consciousness Research — Baltimore, Maryland (recruiting)
FAQ about this NCT record
Is NCT07610135 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07610135?
Phase 1 / Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07610135?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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