Is NCT07386730 recruiting in San Francisco, CA?

Yes, NCT07386730 is currently recruiting participants at its San Francisco, CA location. This anhedonia in healthy volunteers clinical trial is actively enrolling qualified participants.

Is participation in this San Francisco clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Anhedonia in Healthy Volunteers Clinical Trial in San Francisco, CA

Q: How do I join the anhedonia in healthy volunteers clinical trial in San Francisco?

To join this clinical trial in San Francisco, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Anhedonia in Healthy Volunteers Study in San Francisco

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)

Sponsor: Jennifer Mitchell

Who Can Participate

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

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in San Francisco?

Yes, this clinical trial (NCT07386730) has an active research site in San Francisco, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Anhedonia in Healthy Volunteers Treatment Options in San Francisco, CA

If you're searching for anhedonia in healthy volunteers treatment options in San Francisco, CA, this clinical trial (NCT07386730) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our San Francisco research site is actively enrolling participants for this phase 1 clinical trial. You'll receive care from experienced anhedonia in healthy volunteers specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all anhedonia in healthy volunteers clinical trials near you to find additional studies recruiting in your area.

Anhedonia in Healthy Volunteers Clinical Trial in San Francisco, CA

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