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| ID | Type | Description | Link |
|---|---|---|---|
| UG3AG094957 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
| University of California, San Francisco | OTHER |
| Emory University | OTHER |
| Dana-Farber Cancer Institute |
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This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin | Experimental | Two escalating doses of psilocybin 30 days apart |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin (Usona Institute) | Drug | Evaluate the safety and tolerability of psychedelic administration in two cohorts of healthy older adults.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | up to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Total drug exposure (Area Under the Curve, AUC) | Total drug exposure measured with blood samples - Pharmacokinetics | Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation) |
| Elimination Half-life |
| Measure | Description | Time Frame |
|---|---|---|
| Psychedelic Experience (Exploratory) | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary P Mancuso, MA (dual degrees) | Contact | 3037245729 | inspire@cuanschutz.edu | |
| Lila Harris, BS | Contact | lila.m.harris@cuanschutz.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco (UCSF) Department of Neurology | Recruiting | San Francisco | California | 94158 | United States |
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| ID | Term |
|---|---|
| D011562 | Psilocybin |
| ID | Term |
|---|---|
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
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| OTHER |
| NYU Langone Health | OTHER |
| University of Nebraska | OTHER |
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.
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|
Elimination Half-life measured with blood samples - Pharmacokinetics
| 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 | 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 | Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation) |
| Enrollment/Baseline study visit, Week 2, and Week 6 of study participation |
| Well-being & Participant Feedback (Exploratory) | 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 | Enrollment/Baseline study visit, Week 2, Week 6, Week 10, and Week 14 of study participation |
| Pain (Exploratory, optional) | 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. | Enrollment/Baseline study visit, Week 2, and Week 6 of study participation |
| University of Colorado Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| Emory University Brain Health Center | Recruiting | Atlanta | Georgia | 30329 | United States |
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| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| University of Nebraska Medical Center | Not yet recruiting | Omaha | Nebraska | 68105 | United States |
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| New York University Langone Health, Center for Psychedelic Medicine | Not yet recruiting | New York | New York | 10016 | United States |
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D014363 | Tryptamines |
| D054836 | Indolizidines |
| D007212 | Indolizines |