RecruitingPhase 1interventionalRules rewrite

Phase 1: testing Psilocybin (drug) for Anhedonia in Healthy Volunteers

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.

Official registry: https://clinicaltrials.gov/study/NCT07386730 · Jennifer Mitchell · enrollment listed as 80

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Psilocybin (drug), or Dextromethorphan (DXM). The registry lists allocation as randomized. 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.

They plan to enroll about 80 people at San Francisco. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Psilocybin (drug), Dextromethorphan (DXM)

Primary outcome (registry wording): Acute changes in EEG-based ESBA

Who it is for (from inclusion criteria)

Ages 50 Years to 85 Years
The eligibility criteria are deliberately incomplete to preserve the scientific integrity of the study
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
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
Be proficient in English
Stated willingness to comply with all study procedures and availability for the duration of the study

Who the registry excludes

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
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)
History of hallucinogen persisting perception disorder (HPPD) (as per DSM-5 criteria)
Baseline (heart rate \< 60 bpm or \> 90 bpm at screening or pre-dose

Public study contact (from the registry)

Gabriella Mace

415-707-5399

agingandpsychedelics@ucsf.edu

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

University of California San Francisco, Sandler Neuroscience Building — San Francisco, California (recruiting)

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FAQ about this NCT record

Is NCT07386730 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07386730?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07386730?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary