Safety for Home Administration of Microdose Psilocybin Use
ConditionPsychedelic Experiences
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21-60
SponsorJohns Hopkins University
About this trial
The goal of this laboratory study is to establish whether and which microdoses of psilocybin are safe to administer at home to healthy participants.
Eligible participants will be given ascending doses of psilocybin trihydrate and a single, interspersed, randomized placebo on separate days in double-blind fashion. The participants will be asked to complete questionnaires and undergo safety assessments.
Eligibility criteria
Qualifiers
21 to 60 years old
Have given written informed consent
Have at least a high-school level of education or equivalent (e.g. GED) and be fluent in English
Be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests
Disqualifiers
Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control.
Cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g. atrial fibrillation, corrected QT interval (QTc) > 450 msec), artificial heart valve, or transient ischemic attack (TIA) in the past year
Epilepsy
Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia
Trial design
Treatments tested in this trial
- psilocybin trihydrate
- Placebo
Treatment groups
20 Participants
are divided into 5 treatment groupsSponsors and collaborators
Johns Hopkins University
Lead sponsor
Private Philanthropic Funds
Collaborator
Source ClinicalTrials.gov