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NCT Number: NCT07516405

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.

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Key information

Conditions

Healthy Volunteer Older Adults (65-85 Years)

Age range

65 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California San Francisco (UCSF) Department of Neurology, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 65-85 years & be male, female, or non-binary
  • Generally healthy
  • Have an identified support person
  • Capacity to Consent

Exclusion criteria

  • 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
  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

    Total drug exposure measured with blood samples - Pharmacokinetics

  2. Elimination Half-life

    Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

    Elimination Half-life measured with blood samples - Pharmacokinetics

  3. Maximum concentration (Cmax)

    Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

    Maximum plasma concentration (Cmax) measured with blood samples - Pharmacokinetics

  4. Minimum concentration (Cmin)

    Time frame: Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)

    Minimum plasma concentration (Cmin) measured with blood samples - Pharmacokinetics

Other outcomes

  1. Psychedelic Experience (Exploratory)

    Time frame: Enrollment/Baseline study visit, Week 2, and Week 6 of study participation

    Psychedelic Experience: Mystical Experience Questionnaire 4-item (Range: 0-20 (4 items × 0-5 each; higher score predicts greater improvement in clinical outcomes); Persisting Effects Questionnaire-4 (Range: 0-32 (4 items × 0-8 each; drug experience measuring meaningfulness, spiritual significance, psychologically challenges, & personal psychological insights gained); Challenging Experience Questionnaire 7-item (Range: 0-42 (7 items × 0-5 each; higher score indicates more challenging experiences related to psychedelic administration); Emotional Breakthrough Inventory (Range: 0-100, 6 items, higher score indicates emotional breakthroughs in psychedelic experiences & predicts post-psychedelic changes in well-being); Awe Experience Scale (Range: 30-210, 30 items × 1-7 each, six factors: vastness, need for accommodation, altered time perception, self-diminishment, connectedness, physical sensation; Stanford Expectations of Treatment Scale Range: 0-24, positive & negative expectations

  2. Well-being & Participant Feedback (Exploratory)

    Time frame: Enrollment/Baseline study visit, Week 2, Week 6, Week 10, and Week 14 of study participation

    Brief Inventory of Thriving (Brief Inventory of Thriving, Range: 10-50 (10 items × 1-5 each, strongly disagree → strongly agree; Higher scores = greater overall psychological well-being / "thriving" & Participant Feedback Questionnaire, 6 questions, strongly disagree → strongly agree, higher score indicates more positive experience with the study

  3. Pain (Exploratory, optional)

    Time frame: Enrollment/Baseline study visit, Week 2, and Week 6 of study participation

    Pain intensity and tolerance in response to acute noxious stimuli both intensity and the unpleasantness of the sensation. Pin prick task involves the dorsum of the hand to be pricked twice, followed by 2 trains of 10 pricks, 1/second, and 0-100 pain ratings will be collected from 0-10. Cold pressor tasks involves participants submerging their hand in cold water up to 3 minutes and rating pain intensity and unpleasantness every 30 seconds on a 0-100 scale.

Study contacts

Contact information is provided by the study sponsor or research team.

Lila Harris, BS

CONTACT

[email protected]

Mary P Mancuso, MA (dual degrees)

CONTACT

[email protected]

3037245729

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Dana-Farber Cancer Institute
  • Emory University
  • NYU Langone Health
  • National Institute on Aging (NIA)
  • University of California, San Francisco
  • University of Nebraska

Registry information

Official study title

A Multicenter Phase 1 Safety and Tolerability Trial of Psilocybin in Healthy Older Adults

Acronym: Psil-Pk

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 8, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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