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New treatment option for Aging
Official title Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults
ClinicalTrials.gov ID: NCT06367738
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, being studied as a potential treatment for aging.
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
- Participants in this study will undergo a series of non-invasive tests and activities designed to understand how a single dose of psilocybin might influence cognition and emotional well-being in healthy older adults. After providing written informed consent, eligible participants, aged between 60 and 85, will be randomly assigned to receive a dose of psilocybin ranging from a microdose to a moderate-to-high dose.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 to 85. Healthy volunteers may be eligible.
You may be able to join if
- Are 60-85 years of age at time of Informed Consent Form signing. Are able and willing to adhere to study requirements, including attending all study...
- Are able to swallow capsules. Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the...
- Have normal or corrected-to-normal vision as determined by the study staff. Written informed consent obtained from and ability for subject to comply...
- Have an identified support person and agree to be accompanied home (or to an otherwise safe destination) by the support person, or another...
- Agree to inform the investigators within 48 hours of any new or changed medical conditions during the course of their study participation.
You likely can't join if
- Breastfeeding, have a positive pregnancy test at screening or at any point during the course of the study, or unwilling to practice birth control...
- Have a current psychiatric disorder, general medical condition, or other problem or abnormality that, in the opinion of the study clinician or PI...
- Have MRI contraindications (e.g., metal implants, pacemakers, claustrophobia etc.) as determined by an MRI contraindications questionnaire.
- Have a history of recent, clinically significant suicidal ideation or behavior.
- Have a history of a psychotic disorder, bipolar disorder (type I or II), or a dissociative disorder (determined by history).
- History of Hallucinogen Persisting Perception Disorder (HPPD). History of a seizure disorder in adulthood, central nervous system (CNS) metastases or...
See the full eligibility criteria
Who can join
- Are 60-85 years of age at time of Informed Consent Form signing. Are able and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study...
- Are able to swallow capsules. Women of childbearing potential (WOCBP) must agree to practice an effective means of birth control throughout the duration of the study.
- Have normal or corrected-to-normal vision as determined by the study staff. Written informed consent obtained from and ability for subject to comply with the requirements of the study.
- Have an identified support person and agree to be accompanied home (or to an otherwise safe destination) by the support person, or another responsible party, following dosing.
- Agree to inform the investigators within 48 hours of any new or changed medical conditions during the course of their study participation.
- Have access to a quiet space and a computer to perform online assessments.
What rules you out
- Breastfeeding, have a positive pregnancy test at screening or at any point during the course of the study, or unwilling to practice birth control during participation in the study.
- Have a current psychiatric disorder, general medical condition, or other problem or abnormality that, in the opinion of the study clinician or PI, could compromise safety, render them unsuitable for the study, or would...
- Have MRI contraindications (e.g., metal implants, pacemakers, claustrophobia etc.) as determined by an MRI contraindications questionnaire.
- Have a history of recent, clinically significant suicidal ideation or behavior.
- Have a history of a psychotic disorder, bipolar disorder (type I or II), or a dissociative disorder (determined by history).
- History of Hallucinogen Persisting Perception Disorder (HPPD). History of a seizure disorder in adulthood, central nervous system (CNS) metastases or current symptomatic CNS infection.
- History of intracerebral hemorrhage, embolic stroke, transient ischemic attack (TIA), or history of any aneurysmal vascular disease (including thoracic and abdominal aorta, intracranial and peripheral arterial vessels)...
- History of valvulopathy or pulmonary hypertension. Uncontrolled hypertension (Systolic BP\>139mmHG or Diastolic BP\>89mmHG) or tachycardia (average HR\>90bpm) averaged over at least two measurements.
- Clinically significant cardiovascular disease (e.g., history of myocardial infarction or congestive heart failure); or baseline QT/QTc\>500msec; or baseline QT/QTc 451-500msec with repeat QT/QTc \>500msec.
- Poorly controlled diabetes mellitus (e.g., history of an episode of severe hypoglycemia or hospitalization for hyperglycemia on the current diabetes regimen).
- Inadequate hepatic function as determined by total bilirubin or alkaline phosphatase \>3x institutional upper limit of normal; or AST or ALT \>6x institutional upper limit of normal. However, participants with Gilbert...
- Inadequate renal function as determined by eGFR \< 30 mL/min/1.73 m2 (based on the MDRD equation) or CrCl \< 30 mL/min (based on the C-G equation).
- The regular use of psychotropic medications, such as antidepressants (i.e., SSRIs, tricyclic antidepressants, and monoamine oxidase inhibitors), antipsychotics, and mood stabilizers.
- Concomitant dosing of psilocybin with known UGT1A10 and UGT1A9 inhibitors (e.g., diclofenac and probenecid) will be avoided. [There is no exclusion criterion based on the use of medications or substances that are...
- The use of Prohibited Medications:
- Serotonin Reuptake Inhibitors (SSRIs and SNRIs) Tricyclic Antidepressants (TCAs) Monoamine Oxidase Inhibitors (MAOIs) Atypical antidepressants (e.g., mirtazapine, trazodone, buspar) Antipsychotics/Neuroleptics (typical...
- Other drugs associated with the serotonin syndrome (e.g., ondansetron) used within 48 hours of study drug administration.
- Vasoactive drugs (e.g., sildenafil, sumatriptan, calcium channel blockers) used within 48 hours of study drug administration.
- Unable to agree to the following required Lifestyle Modifications: Patients will be asked to refrain from consuming alcohol, cannabinoids, prescription analgesics/stimulants/benzodiazepines, and any recreational drugs...
- Recent and lifetime use of psychedelics (e.g. psilocybin, LSD, mescaline), entactogens (e.g. MDMA), or dissociative anesthetics (e.g. ketamine) above a predetermined threshold.
- Has been diagnosed with any disease that impairs motor function (e.g., Parkinson's disease) At high risk of falls as determined by study physician considering medical history, screening of recent symptoms and...
The study team makes the final eligibility decision.
Where it's taking place
- Berkeley, 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 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 Berkeley, 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.