Psilocybin for Aging

Overseen By BCSP Research Staff

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of California, Berkeley

Must not be taking: Antidepressants, Antipsychotics, Mood stabilizers, others

Disqualifiers: Psychiatric disorder, Cardiovascular disease, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Participants in this study will undergo a series of non-invasive tests and activities designed to understand how a single dose of psilocybin might influence cognition and emotional well-being in healthy older adults. After providing written informed consent, eligible participants, aged between 60 and 85, will be randomly assigned to receive a dose of psilocybin ranging from a microdose to a moderate-to-high dose. Anatomical magnetic resonance imaging (MRI) and diffusion weighted imaging (DWI) will be used to assess changes in brain structure, while functional magnetic resonance imaging (fMRI) will be used to quantify changes in functional brain activity.

Are You a Good Fit for This Trial?

Healthy adults aged 60-85 who can swallow capsules, attend all study visits, and have a support person. They must not have MRI contraindications, psychiatric disorders, significant cardiovascular disease, poorly controlled diabetes or other serious health issues. Women of childbearing potential must use birth control.

Inclusion Criteria

I am between 60 and 85 years old.

Are able and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations

I can swallow capsules.

Exclusion Criteria

Have MRI contraindications (e.g., metal implants, pacemakers, claustrophobia etc.) as determined by an MRI contraindications questionnaire

I have had recent thoughts or actions related to suicide.

I have a history of heart valve issues or high blood pressure in the lungs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of psilocybin ranging from microdose to moderate-to-high dose

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at baseline, week 1, and week 4

4 weeks

3 visits (in-person)

Extended Follow-up

Additional assessments to measure long-term effects at week 8

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

Trial Overview The trial is studying the impact of a single dose of psilocybin on brain structure and function in older adults using MRI and fMRI scans. Participants will be randomly assigned to receive varying doses from microdose to moderate-to-high.

How Is the Trial Designed?

Group I: Psilocybin Level 3 Experimental Treatment 1 Intervention

The effects of different doses of psilocybin (21 - 30 mg) will be compared.

Group II: Psilocybin Level 2 Experimental Treatment 1 Intervention

The effects of different doses of psilocybin (11 - 20 mg) will be compared.

Group III: Psilocybin Level 1 Experimental Treatment 1 Intervention

The effects of different doses of psilocybin (1 - 10 mg) will be compared.

Who Is Running the Clinical Trial?

University of California, Berkeley

Lead Sponsor

Trials

193

Recruited

716,000+