Safety and Tolerability Trial of Psilocybin in Healthy Older Adults
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age65-85
SponsorUniversity of Colorado, Denver
About this trial
This study plans to learn more about the safety and tolerability of psychedelic administration (psilocybin) in healthy older adults ages 65-85.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Aged 65-85 years & be male, female, or non-binary
Generally healthy
Have an identified support person
Capacity to Consent
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Psilocybin (Usona Institute)
DrugEvaluate 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.
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: PsilocybinExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
up to 14 weeksSecondary outcomes
1
Total drug exposure (Area Under the Curve, AUC)
Total drug exposure measured with blood samples - Pharmacokinetics
Time frame
Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)2
Elimination Half-life
Elimination Half-life measured with blood samples - Pharmacokinetics
Time frame
Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)3
Maximum concentration (Cmax)
Maximum plasma concentration (Cmax) measured with blood samples - Pharmacokinetics
Time frame
Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)4
Minimum concentration (Cmin)
Minimum plasma concentration (Cmin) measured with blood samples - Pharmacokinetics
Time frame
Two separate medication administration days 30 days apart (Week 2 & Week 6 of study participation)Other outcomes
1
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
Time frame
Enrollment/Baseline study visit, Week 2, and Week 6 of study participation2
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
Time frame
Enrollment/Baseline study visit, Week 2, Week 6, Week 10, and Week 14 of study participation3
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.
Time frame
Enrollment/Baseline study visit, Week 2, and Week 6 of study participationSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Colorado, Denver
Lead sponsor
National Institute on Aging (NIA)
Collaborator
University of California, San Francisco
Collaborator
Emory University
Collaborator
Dana-Farber Cancer Institute
Collaborator
NYU Langone Health
Collaborator
University of Nebraska
Collaborator
Source ClinicalTrials.gov