Study of Psilocybin and Dextromethorphan in Older Adults with Low Well-being
This study is looking for healthy older adults, aged 50 to 85, who have low well-being. The goal is to understand how two different drugs, Psilocybin and Dextromethorphan, affect brain activity. Researchers want to see if Psilocybin can increase the complexity of brain wave patterns (measured by EEG, or electroencephalogram) and decrease inflammation markers in the blood. They will also explore changes in body functions using wearable devices and brain structure/function with MRI scans. You will be in the study for up to 3 months. The study is currently unclear on its recruitment status and plans to enroll 80 participants.
- Study design
- This interventional study plans to enroll 80 participants. You will receive either Psilocybin or Dextromethorphan.
- What's involved
- You will be in the study for up to 3 months, which will include 3 to 4 in-person visits. Procedures include EEG measurements, blood tests, wearable device use, and MRI scans.
- Compensation
- Not stated in the trial record.
- Follow-up
- Acute changes in EEG are measured two hours after dosing. Longitudinal changes in blood markers and brain activity will be explored over the study period of up to 3 months.
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NCT07386730
A Study of Psychedelics in Healthy Older Adults With Low Well-being
Recruiting
PHASE1Ages 50–85InterventionalTreatmentJennifer MitchellInvestigator-initiated
~80 participants
Updated 2026-06-08 on ClinicalTrials.gov
What's tested:Psilocybin (drug)Dextromethorphan (DXM)
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Acute changes in EEG-based ESBA
Measured over Pre- to post-dose two hours later
Conditions
Where it's being run
1 sites across 1 statesCalifornia1
Study leadership
- Lorenzo Pasquini, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
- Jennifer Mitchell, PhD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Are between 50-85 years inclusive at time of consent signing
Have below-average well-being, defined by the World Health Organization Well-Being Index (WHO-5)
Have no cognitive impairments, indicated by a Mini-Mental State Examination (MMSE) score \>24
Have an identified willing contact person with at least weekly contact with the participant to be able to provide meaningful information about the participant's daily function and able to pick up the study participant at the end of the Dosing Visit
Participants assigned female sex at birth must be non-lactating, and post-menopausal, defined as a period of over 12 months since the last menstrual period, or otherwise physically unable to become pregnant
Participants assigned male sex at birth must 1) refrain from sperm donation for 3 months after the Dosing Visit, and 2) if engaging in sexual activities that may result in pregnancy, must use a condom, plus their partner of childbearing potential must use a second, highly effective form of contraception for 3 months after the Dosing Visit
Be proficient in English
Are able and willing to provide consent as assessed by comprehension questions in informed consent process
Stated willingness to comply with all study procedures and availability for the duration of the study
Ability to swallow oral medications (capsules)
Exclusion
Have a known allergic or severe reaction to Psilocybin, Dextromethorphan, or any of the non-active components of the IMP capsules
Insufficient ability to report on symptoms to make a valid assessment on any required instrument
Have a condition or presence of clinical feature which, in the opinion of the investigators might interfere with or prevent appropriate study participation or interfere with data interpretation
Any implanted object or device that poses a safety risk or could interfere with MRI scanning (e.g. aneurysm clips, cardiac pacemakers, defibrillators, neurostimulators, cochlear implants, spinal cord stimulators, insulin or infusion pumps, metallic prostheses or fragments, heart valves, vascular stents, or shunts. surgical staples, clips, or joint replacements, radiation seeds, medication patches containing metal, or any other metallic or electronic implants)
History of metallic injury to the eyes or body, or those with tattoos containing metallic ink, permanent makeup, or body piercings that cannot be removed.
Any condition that poses a safety risk or could interfere with MRI scanning (e.g. severe claustrophobia or motion disorders or breathing problems, etc)
Clinically significant cardiovascular conditions e.g., clinically significant EKG abnormalities, transient ischemic attack in the last 6 months, history of hemorrhagic stroke, history of myocardial infarction within 1 year of signing informed consent form (ICF)
Baseline (heart rate \< 60 bpm or \> 90 bpm at screening or pre-dose
Baseline hypertension (≥140 SBP or ≥90 DBP), after repeated measurements
QTc Interval \> 450msec on 12-lead EKG. Note: If QT-prolonging medications are started or increased in dose after enrollment and prior to dosing visit, a repeat EKG must be done \>12-hours after this change to assure continued safe enrollment in the trial
Clinically significant arrhythmia (e.g., uncontrolled atrial fibrillation, or untreated supraventricular tachycardia)
Any current condition where physical activity is associated with palpitations, anginal pain or syncope
Major systemic disorders, including seizure, insulin dependent diabetes mellitus, recent history (last 12 months) of advanced cancer or its treatment (radiation therapy or chemotherapy), had major surgery within 6 months from screening or plans to have surgery while enrolled in the study
Inadequate hepatic function as determined by total bilirubin or alkaline phosphatase \>3x institutional upper limit of normal; or aspartate aminotransferase (AST) or alanine transaminase (ALT) \>3x institutional upper limit of normal. However, participants with Gilbert syndrome are allowed to enroll
Inadequate renal function as determined by estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 (based on the MDRD equation)
Participant is at increased risk of falls
What this trial measures
- Acute changes in EEG-based ESBAPre- to post-dose two hours later
Compare acute changes in EEG-based Lempel Ziv complexity (pre- to post-dose, arbitrary unit) between the four study arms, with the presence of biomarkers of AD pathology used in the statistical analyses as a moderator. Lempel-Ziv complexity in EEG is a non-linear analysis tool that quantifies the amount of entropy of spontaneous brain activity (ESBA).