A Study of Psychedelics in Healthy Older Adults With Low Well-being

ConditionsAnhedonia in Healthy Volunteers Older Adults (50-90 Years)

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age50-85

SponsorJennifer Mitchell

About this trial

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)

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

Psilocybin (drug)
Drug
Participants will receive either Psilocybin or Dextromethorphan in this clinical trial
Dextromethorphan (DXM)
Drug
Participants will receive either Psilocybin or Dextromethorphan in this clinical trial

Treatment groups

80 Participants

are divided into 4 treatment groups

Group A: A low-to-moderate dose of Psilocybin (5-10 mg)Experimental treatment 1 intervention

Group B: A moderate-to-high dose of Psilocybin (25-30 mg)Experimental treatment 1 intervention

Group C: A low-to-moderate dose of Dextromethorphan (30-60 mg)Experimental treatment 1 intervention

Group D: A moderate-to-high dose of Dextromethorphan (80-90 mg)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

Acute changes in EEG-based ESBA

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).

Time frame

Pre- to post-dose two hours later

Secondary outcomes

Changes in TNF-alpha

Compare changes in a biomarkers of neuroinflammation (TNF-alpha) psilocybin across the four study arms, with the presence of biomarkers of AD pathology used in the statistical analyses as a moderator. Reference Range 0.56-1.40 pg/mL

Time frame

Screening to three weeks post dosing

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jennifer Mitchell

Lead sponsor

University of California, San Francisco

Sponsor institution

Source ClinicalTrials.gov

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