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New treatment option for Anhedonia in Healthy Volunteers
Official title A Study of Psychedelics in Healthy Older Adults With Low Well-being
ClinicalTrials.gov ID: NCT07386730
What this study is testing
What is Psilocybin (drug)?
Psilocybin (drug) is an investigational medicine, being studied as a potential treatment for anhedonia in healthy volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 3 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 85. Healthy volunteers may be eligible.
You may be able to join if
- 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
- Have an identified willing contact person with at least weekly contact with the participant to be able to provide meaningful information about the...
You likely can't join if
- 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...
- Any implanted object or device that poses a safety risk or could interfere with MRI scanning (e.g. aneurysm clips, cardiac pacemakers...
- History of metallic injury to the eyes or body, or those with tattoos containing metallic ink, permanent makeup, or body piercings that cannot be...
See the full eligibility criteria
- 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
- 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...
- 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...
- 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)
- 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...
- 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...
- 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...
- Baseline (heart rate \ 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...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 3 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.