Psilocybin for Elderly

(Psil-Pk Trial)

Recruiting at 5 trial locations

Overseen By Lila Harris, BS

Age: 65+

Sex: Any

Trial Phase: Phase 1

Sponsor: University of Colorado, Denver

Must not be taking: Serotonergic agents, Antipsychotics

Disqualifiers: Unstable condition, CNS pathology, others

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

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.

Are You a Good Fit for This Trial?

Inclusion Criteria

Capacity to Consent

I am between 65 and 85 years old.

Generally healthy

Exclusion Criteria

Family history of psychotic or serious bipolar spectrum illnesses

Primary psychotic or affective psychotic disorders

Extensive use of serotonergic hallucinogens

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two escalating doses of psilocybin 30 days apart

8 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Psilocybin

How Is the Trial Designed?

Group I: Psilocybin Experimental Treatment 1 Intervention

Two escalating doses of psilocybin 30 days apart

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

University of Nebraska

Collaborator

Trials

563

Recruited

1,147,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+