Safety for Home Administration of Microdose Psilocybin Use

NCT ID: NCT06450210

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-06
• Study Completion Date: 2027-06-30

Brief Summary

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.

Detailed Description

This study aims to enroll 20 healthy participants who will complete all study procedures. Participants will undergo a standard screening procedure. Baseline measures will be completed before the first dose. Participants will then be given ascending doses of psilocybin trihydrate (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg) and a single, interspersed, randomized placebo on separate days in double-blind fashion at the research site. A 1 mg dose of psilocybin anhydrate is equivalent to a 1.19 mg dose of psilocybin trihydrate (used in this study). For each session, participants will be assessed with criteria for the safety of home dosing. If any dose meets criteria for at-home dosing, and a lower dose did not fail these criteria, that dose will be identified as the safe dose for the given participant. After administration of all doses of psilocybin to all participants, if a safe at-home dose was identified for all participants, that will be considered the highest safe dose for at-home administration to be used for future studies.

Visit summary:

Initial screening: Medical and psychological screening (Approx. 4 hours though portions of this may be completed remotely).

Dosing sessions: There will be 5 double-blind laboratory dosing sessions involving administration of ascending doses of psilocybin and a single, interspersed, randomized placebo dose. Baseline questionnaires will be completed on the day of the first dosing visit, and safety assessments will be administered during and at the end of each session.

Conditions

Psychedelic Experiences

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

1.2 mg psilocybin trihydrate microdose

Participants will receive a single microdose of 1.2 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion.

Group Type: EXPERIMENTAL

psilocybin trihydrate

Intervention Type: DRUG

Microdoses of psilocybin trihydrate will be administered to participants (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg).

2.0 mg psilocybin trihydrate microdose

Participants will receive a single microdose of 2.0 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion.

Group Type: EXPERIMENTAL

psilocybin trihydrate

Intervention Type: DRUG

Microdoses of psilocybin trihydrate will be administered to participants (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg).

3.0 mg psilocybin trihydrate microdose

Participants will receive a single microdose of 3.0 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion.

Group Type: EXPERIMENTAL

psilocybin trihydrate

Intervention Type: DRUG

Microdoses of psilocybin trihydrate will be administered to participants (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg).

4.2 mg psilocybin trihydrate microdose

Participants will receive a single microdose of 4.2 mg psilocybin trihydrate via oral capsule in the laboratory in double-blind fashion.

Group Type: EXPERIMENTAL

psilocybin trihydrate

Intervention Type: DRUG

Microdoses of psilocybin trihydrate will be administered to participants (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg).

Placebo

Participants will receive a single placebo oral capsule in the laboratory in double-blind fashion.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive a capsule identical in appearance to the active drug that contains an inactive substance.

Interventions

psilocybin trihydrate

Microdoses of psilocybin trihydrate will be administered to participants (1.2 mg, 2.0 mg, 3.0 mg, and 4.2 mg).

Intervention Type: DRUG

Placebo

Participants will receive a capsule identical in appearance to the active drug that contains an inactive substance.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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
• Agree to refrain from using any psychoactive drugs, including alcoholic beverages and nicotine, within 24 hours of each drug administration. The exception is caffeine.
• Agree not to take any as needed (PRN) medications on the mornings of drug sessions
• Agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.
• Agree that for one week before each drug session, he/she will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.
• Licensed to drive (for driving simulator test).

Exclusion Criteria

• 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
• Currently taking psychoactive drugs (prescribed or not) on a daily basis. This includes nicotine but excepts caffeine.
• Currently taking on a regular (e.g. daily) basis any medications having a centrally-acting serotonergic effect, including monoamine oxidase inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least five half-lives of the agent have elapsed after the last dose.
• More than 20% outside the upper or lower range of ideal body weight according to Metropolitan Life height and weight table
• History of schizophrenia spectrum disorder
• History of bipolar I disorder
• History of substance induced psychotic disorder
• Current history of meeting Diagnostic and Statistical Manual (DSM)-5 criteria for a moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)
• Have a first degree relative with bipolar I disorder, or schizophrenia spectrum disorder.

Cardiovascular screening: To qualify for the study, blood pressure at screening will be less than 130 mmHg systolic, 80 mmHg diastolic, and 90 beats per minute; mean heart rate must also be no less than 40 beats per minute. Blood pressure will be taken while subjects are at rest and have been seated or supine for at least 5 minutes.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Private Philanthropic Funds

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandeep M. Nayak, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

5510 Nathan Shock Drive

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Matthew Nielsen Dick

Role: CONTACT

microdose@jh.edu

410-999-8066

Facility Contacts

Matthew H Nielsen Dick, BA

Role: primary

microdose@jh.edu

410-999-8066

Other Identifiers

IRB00422973

Identifier Type: -

Identifier Source: org_study_id