Healthy VolunteerPhase 1Psil-PkNCT07516405
Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
A Phase 1 study testing Psilocybin (Usona Institute) in people with Healthy Volunteer and Older Adults (65-85 Years), run by University of Colorado, Denver at 6 sites in United States.
Trial summary
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85. Read more about this study
- Who is it for?
- Ages 65 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Older Adults (65-85 Years)
- What is being tested?
- Psilocybin (Usona Institute)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Apr 2026to Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65-85 years \& be male, female, or non-binary
- Generally healthy
- Have an identified support person
- Capacity to Consent
Who cannot join
- Unstable medical condition
- Risk for hypertensive crisis (screening blood pressure >140/90 mmHg)
- Significant central nervous system (CNS) pathology
- Primary psychotic or affective psychotic disorders
- Family history of psychotic or serious bipolar spectrum illnesses
- High risk of adverse emotional or behavioral reaction
Show all 13Show fewer
- Active substance use disorders (SUDs)
- Extensive use of serotonergic hallucinogens
- High risk of completed suicide
- History of hallucinogen persisting perception disorder (HPPD)
- Concurrent Medications: centrally-acting serotonergic agents; antipsychotics; certain mood stabilizers, aldehyde dehydrogenase inhibitors; significant inhibitors of UGT 1A9 or UGT 1A10
- Certain psychiatric conditions
- Presence of relevant finding (psychological, physical symptom, medication) prior to dosing that would make a participant unsuitable for the study
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lila Harris, BS contact
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Emory University Brain Health Center
Atlanta, Georgia, 30329
Tanja Mletzko, MA, 404-778-6663, study@emory.edu
Joyelle Van Eron, MPH, 404-727-8966, jvanero@emory.edu
- Recruiting
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
Mary Mancuso, MS, 303-724-5729, inspire@cuanschutz.edu
Lila Harris, BA
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Gabriel Najarian, patresearch@dfci.harvard.edu
Yvan Beaussant, MD
- Recruiting
New York University Langone Health, Center for Psychedelic Medicine
New York, New York, 10016
Denise Balili, MS, 646-501-2623, denise.balili@nyulangone.org
Stephen Ross, MD
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68105
Jennifer Wettschreck, MS, 402-559-3342, jemurray@unmc.edu
Lou Lukas, MD
- Recruiting
University of California San Francisco (UCSF) Department of Neurology
San Francisco, California, 94158
Jennifer Mitchell, PhD, 510-985-3522, psy.elder@ucsf.edu
Jennifer Mitchell, PhD
About this study
Official title: A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Read the detailed description
The purpose of this study is to learn whether psilocybin, a psychedelic compound, can be given safely to older adults. We want to understand how psilocybin affects the body and mind, including blood pressure, heart rhythm, and mood. We also want to see how the body processes psilocybin (how quickly it is absorbed and cleared) and whether it affects thinking, memory, or wellbeing.
- Primary Objective: Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults.
- Cohort 1a Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart.
- Cohort 1b Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart.
- Secondary Objectives: Evaluate the pharmacokinetics of Psilocybin for each Cohort of healthy older adults.
- Exploratory Objectives: Evaluate patient-reported outcomes related to Psilocybin administration (e.g., psychedelic experience and well-being) in each Cohort.
Assess the relationships between the pharmacokinetic profile, safety endpoints, and patient-reported outcomes in each Cohort.
- Conditions
- Healthy Volunteer, Older Adults (65-85 Years)
- Being tested
- Psilocybin (Usona Institute)
- Keywords
- healthy older adults ages 65-85, psilocybin safety, psilocybin tolerability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin (Usona Institute)Drug
Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults.
- Cohort 1a Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart.
- Cohort 1b Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin | Experimental | Two escalating doses of psilocybin 30 days apart Receives: Drug: Psilocybin (Usona Institute) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Frequency and severity of adverse events; Proportion of participants who complete the intervention, do not advance to the second dose, and who withdraw early from the trial
Measured: up to 14 weeks
Secondary outcomes (4)
Total drug exposure (Area Under the Curve, AUC)
Total drug exposure measured with blood samples - Pharmacokinetics
Measured: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)
Elimination Half-life
Elimination Half-life measured with blood samples - Pharmacokinetics
Measured: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)
Maximum concentration (Cmax)
Maximum plasma concentration (Cmax) measured with blood samples - Pharmacokinetics
Measured: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)
Minimum concentration (Cmin)
Minimum plasma concentration (Cmin) measured with blood samples - Pharmacokinetics
Measured: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start1 Apr 2026
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort model: each cohort will receive 2 escalating doses of psilocybin 30 days apart. The first 20 participants will follow this schema: Cohort 1a: Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart. If tolerated in the first 20 participants, the second 20 participants will follow this schema: Cohort 1b: Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of California, San Francisco, Emory University, Dana-Farber Cancer Institute, NYU Langone Health, University of Nebraska
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516405
- Sponsor's protocol ID
- 25-2070
- Other IDs
- UG3AG094957
- Acronym
- Psil-Pk
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT07516405
- Acronym / sponsor ID
- Psil-Pk / 25-2070
- Conditions
- Healthy Volunteer, Older Adults (65-85 Years)
- Keywords
- healthy older adults ages 65-85, psilocybin safety, psilocybin tolerability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA), University of California, San Francisco, Emory University, Dana-Farber Cancer Institute, NYU Langone Health, University of Nebraska
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Detailed description
The purpose of this study is to learn whether psilocybin, a psychedelic compound, can be given safely to older adults. We want to understand how psilocybin affects the body and mind, including blood pressure, heart rhythm, and mood. We also want to see how the body processes psilocybin (how quickly it is absorbed and cleared) and whether it affects thinking, memory, or wellbeing.
- Primary Objective: Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults.
- Cohort 1a Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart.
- Cohort 1b Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart.
- Secondary Objectives: Evaluate the pharmacokinetics of Psilocybin for each Cohort of healthy older adults.
- Exploratory Objectives: Evaluate patient-reported outcomes related to Psilocybin administration (e.g., psychedelic experience and well-being) in each Cohort.
Assess the relationships between the pharmacokinetic profile, safety endpoints, and patient-reported outcomes in each Cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort model: each cohort will receive 2 escalating doses of psilocybin 30 days apart. The first 20 participants will follow this schema: Cohort 1a: Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart. If tolerated in the first 20 participants, the second 20 participants will follow this schema: Cohort 1b: Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart.
| Arm | Type | Receives |
|---|---|---|
| Psilocybin | Experimental | Drug: Psilocybin (Usona Institute)Two escalating doses of psilocybin 30 days apart |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65-85 years \& be male, female, or non-binary
- Generally healthy
- Have an identified support person
- Capacity to Consent
Key exclusion criteria (13 listed)
- Unstable medical condition
- Risk for hypertensive crisis (screening blood pressure >140/90 mmHg)
- Significant central nervous system (CNS) pathology
- Primary psychotic or affective psychotic disorders
- Family history of psychotic or serious bipolar spectrum illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin (Usona Institute)Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults. * Cohort 1a Psilocybin Moderate Dose: 2 doses of oral psilocybin (10mg and then 25mg) 30 days apart. * Cohort 1b Psilocybin High Dose: 2 doses of oral psilocybin (15mg and then 30mg) 30 days apart. | Drug | Psilocybin |
Primary outcome
Adverse Events
Time frame: up to 14 weeks
Frequency and severity of adverse events; Proportion of participants who complete the intervention, do not advance to the second dose, and who withdraw early from the trial
4 secondary outcomes
Total drug exposure (Area Under the Curve, AUC)
Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)
Elimination Half-life
Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)
Maximum concentration (Cmax)
Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)
Minimum concentration (Cmin)
Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lila Harris, BS contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Psilocybin (Usona Institute) in people with Healthy Volunteer and Older Adults (65-85 Years), run by University of Colorado, Denver at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mary P Mancuso, MA (dual degrees) (3037245729, inspire@cuanschutz.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: up to 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.