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New treatment option for Healthy Participants With Lower-than-average Mental Well-being
Official title Investigating the Interaction of Psilocybin and Context of Its Administration in Healthy Volunteers
ClinicalTrials.gov ID: NCT06626139
What this study is testing
What is Psilocybin?
Psilocybin is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for healthy participants with lower-than-average mental well-being.
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
- One hundred twenty healthy participants, ages 21 to 70, who experience moderate-to-lower-than-average mental well-being will be evenly randomized into four different study arms, using a 2x2 factorial design. Depending on the study arm, participants will either receive an inactive placebo or up to 25mg psilocybin (oral dose), in one of two set and setting conditions; drug administration contexts that are predicted to modulate drug effects.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 70. Healthy volunteers may be eligible.
You may be able to join if
- If you are interested in participating in this study, please follow this link to check your eligibility: https://tiny.ucsf.edu/setsettingscreener...
- Are between 21 and 70 years of age
- Are fluent in speaking and reading English
- Are able to swallow pills/capsules
- If able to become pregnant, must be non-lactating, have a negative pregnancy test at study entry and prior to each Experimental Session and must...
You likely can't join if
- Participants will be excluded if they:
- Have a current diagnosed psychiatric disorder that, in the opinion of the study clinician or PI, renders to person psychologically unstable or unduly...
- Have a medically significant condition that renders the person unsuitable for the study
- Give a positive alcohol breathalyzer test result on any study visit
- A positive urine drug screen to any excluded substances prior to an Experimental Session, which warrants exclusion based on concerns that it may...
- Are breastfeeding, or have a positive pregnancy test at screening or at any point during the course of the study
See the full eligibility criteria
- If you are interested in participating in this study, please follow this link to check your eligibility: https://tiny.ucsf.edu/setsettingscreener Participants will be considered for inclusion if they:
- Are between 21 and 70 years of age
- Are fluent in speaking and reading English
- Are able to swallow pills/capsules
- If able to become pregnant, must be non-lactating, have a negative pregnancy test at study entry and prior to each Experimental Session and must agree to an adequate form of birth control over the course of the study...
- Able and willing to provide informed consent
- Able and willing to use computers and tablets or phones to enter electronic data
- Agree to inform the investigators within 48 hours of any new or changed medical conditions.
- Have an identified support person
- For those dosed with psilocybin, their prior consent to be accompanied home (or to an otherwise safe destination) by a support person, chosen by them - ahead of time, or by a member of the study team.
- Willing to provide contact details for a friend or family member, should there be an inability to make direct contact with the participant
- Participants will be excluded if they:
- Have a current diagnosed psychiatric disorder that, in the opinion of the study clinician or PI, renders to person psychologically unstable or unduly vulnerable, or interferes with activities of daily living, or could...
- Have a medically significant condition that renders the person unsuitable for the study
- Give a positive alcohol breathalyzer test result on any study visit
- A positive urine drug screen to any excluded substances prior to an Experimental Session, which warrants exclusion based on concerns that it may compromise safety or confound outcomes
- Are breastfeeding, or have a positive pregnancy test at screening or at any point during the course of the study
- Systolic and diastolic BP values exceeding 139 SBP and exceeding 89 DBP and heart rate exceeding 90 bpm would result in exclusion from the study.
- Present with a exceeding 450 msec or with evidence of cardiac damage, ischemia, or heart disease.
- Have received an investigational drug within 30 days of the screening visit
- Have an allergy or intolerance to any of the materials contained in either drug product or setting components, such as certain scents.
- Have MRI contraindications (e.g., metal implants, pacemakers, claustrophobia etc.)
- Have any current problem which, in the opinion of the investigator or clinician, might interfere with participation.
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 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, 21 years to 70 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.