A Study of Psychedelics in Healthy Older Adults With Low Well-being
A Double Blind, Randomized Trial Investigating the Safety, Feasibility, and Mechanisms of Psychedelics in Healthy Older Adults With Low Well-being as Moderated by Biomarkers for Preclinical Alzheimer's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 50 Years to 85 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 4 visits
- Time periods mentioned: 3 months
- Procedures mentioned: MRI scans, Wearing a device
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Explore longitudinal changes in autonomic physiology via wearable recording devices as well as longitudinal structural and functional brain changes measured in the MRI Participants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how psilocybin and dextromethorphan affect brain activity in healthy adults ages 50–85 with low well-being. Researchers will also track brain changes and blood signs of inflammation, and look at whether signs of Alzheimer's disease affect the results. The study lasts up to 3 months and includes one drug visit lasting 8–12 hours.
This study is being conducted to understand changes in brain activity following administration of two different drugs (Psilocybin and Dextromethorphan) in older adults with low well-being. The main questions it aims to answer are, does psilocybin: 1. Acutely increase complexity of EEG activity in older adults with low well-being, as modulated by the presence of biomarkers of Alzheimer's disease (AD) pathology. 2. Longitudinally decrease plasma markers of neuroinflammation, as modulated by the presence of biomarkers of AD pathology. 3. Explore longitudinal changes in autonomic physiology via wearable recording devices as well as longitudinal structural and functional brain changes measured in the MRI Participants will be in the study for up to 3 months, which will include 3 to 4 in person visits and 3 to 4 remote visits. Most visits will be between 1 to 3 hours, but the dosing visit will last a minimum of 8 hours and could be as long as 12 hours. During the dosing visit, all participants will receive a single dose of the study drugs and dosages listed below. Researchers will compare participants who receive the following drug options: * A low-to-moderate dose of Psilocybin (5-10 mg) * A moderate-to-high dose of Psilocybin (25-30 mg) * A low-to-moderate dose of Dextromethorphan (30-60 mg) * A moderate-to-high dose of Dextromethorphan (80-90 mg)
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be age 50–85 and have below-average well-being on a study survey.
- Have no problems with memory or thinking, with a score above 24 on the MMSE screening test.
- Have a willing contact person who sees or talks with you at least weekly, can describe your daily abilities, and can pick you up after the drug visit.
- If assigned female at birth: not be breastfeeding, and have had no period for over 12 months or otherwise be physically unable to become pregnant.
- If assigned male at birth: not donate sperm for 3 months after the drug visit. If sex could lead to pregnancy, use a condom and have your partner use a second, highly effective birth control method during that time.
- Know English well and be able to show that you understand and agree to join the study.
- Be willing to follow all study steps and be available for the full study.
- Be able to swallow capsules.
Who can't join
- Have a known allergy or severe reaction to either study drug or other capsule ingredients.
- Be unable to report symptoms well enough, or have a condition that researchers believe could affect participation or study results.
- Have implants, metal, or other safety risks that prevent MRI brain scans. These may include certain tattoos, piercings that cannot be removed, severe fear of closed spaces, or movement or breathing problems.
- Have a history of lasting changes in what you see after using drugs that cause hallucinations.
- Have serious heart or blood vessel problems, certain abnormal heart tests or rhythms, a mini-stroke in the past 6 months, a past bleeding stroke, or a heart attack within the past year. Symptoms with activity, such as chest pain, racing heart, or fainting, also exclude you.
- Have a resting heart rate below 60 or above 90 beats per minute, repeated blood pressure readings with a top number of 140 or higher or bottom number of 90 or higher, or a QTc heart-test result above 450 milliseconds.
- Have a major illness, such as seizures or diabetes needing insulin; advanced cancer or its treatment in the past 12 months; or major surgery within 6 months before screening or planned during the study.
- Have liver or kidney test results outside the study's limits, or an increased risk of falls. Gilbert syndrome, a liver condition, is allowed.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
The eligibility criteria are deliberately incomplete to preserve the scientific integrity of the study. Inclusion Criteria: * 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 Criteria: General: * 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 MRI Exclusions: * 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) Psychiatric: •History of hallucinogen persisting perception disorder (HPPD) (as per DSM-5 criteria) Cardiovascular: * 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 General health: * 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
Study sites (1)
CA
- University of California San Francisco, Sandler Neuroscience Building · San Francisco, CA 94158Gabriella Mace · Study contact · 415-707-5399 · agingandpsychedelics@ucsf.eduLorenzo Pasquini, PhD · Sub-investigatorJennifer Mitchell, PhD · Principal investigatorMore trials in San Francisco