About the study
Most psilocybin trials enroll people with a single diagnosis and screen out everyone else. That is not how psychiatric illness presents. This study takes the opposite approach: it enrolls adults whose mood, anxiety, trauma, or addiction symptoms are getting in the way of daily life, whether or not those symptoms carry a formal DSM-5 diagnosis, and whether or not there are several of them at once. Comorbidity is expected, not excluded.
Participants receive a single 25 mg oral dose of psilocybin with non-directive support before, during, and after the session. Assessments follow at one, four, and six weeks, with optional long-term follow-up at three, six, and twelve months. The study asks first whether this treatment is safe and tolerable in a population that reflects real clinical practice, and second whether symptoms and day-to-day functioning improve.
Is this study a fit?
The study team makes the final decision after screening. These points give you a sense of who the study is designed for.
You may be a fit if you
- Are 18 or older
- Have depression, anxiety, trauma, obsessive-compulsive or substance-use symptoms that make daily life hard
- Have tried at least one standard medication or therapy without enough relief
- Have an outside clinician or therapist we can coordinate with
- Can name an adult contact who can support you and take you home after dosing
- Are medically stable. A formal diagnosis is not required
The study may not be safe if you
- Have a personal or close-family history of schizophrenia, other psychotic disorders or bipolar I disorder
- Have recent active suicidal intent
- Take certain medications, such as MAOIs, lithium or methadone
- Have high blood pressure or certain heart conditions
- Are pregnant, breastfeeding or planning a pregnancy
Does most of the first list describe you? The next step is a short, no-commitment inquiry.
Check if I'm a fitWhat taking part looks like
The study runs in eight steps. After you sign consent, there are about nine visits over 8 to 9 weeks. Open any step for details.
Phone pre-screenBefore any visitsA short call to see whether the study may be a fit.
A team member calls you to walk through the study and asks a short set of questions about your health history. Nothing is decided on this call, and you can stop at any time.
ConsentVisit 0Review the study in detail and ask any questions before you agree.
A study physician or coordinator goes through the consent form with you, and you have as much time as you need for questions. You also name an adult contact and give us permission to speak with your current clinician or therapist.
Visit 0In person or ZoomConsent session
- Review the study, risks and benefits
- Sign consent (in person, if reviewed over Zoom)
- Release to contact your provider
ScreeningVisits 1–2 · up to 4 weeksClinical interviews and a medical check-up to make sure the study is safe for you.
The first visit focuses on your mental health history; the second is a medical check-up. Bring your medical records, including medication and therapy history.
Visit 1In person or ZoomClinical interviews
- Structured interviews about symptoms
- Questionnaires on daily functioning
- Review of your medical records
Visit 2In personMedical check-up
- Physical exam and vital signs
- Heart tracing (ECG)
- Blood and urine tests, including a drug screen and pregnancy test if applicable
PreparationVisits 3–4 · about 1.5 hours eachTwo sessions with the facilitators who will be with you on dosing day.
You talk about your symptoms, goals and any worries, and learn what the experience can feel like and how to work with difficult moments. You also begin a brief daily online diary.
Visit 3In person or ZoomBaseline and first preparation
- Baseline symptom and functioning measures
- Meet your facilitators
Visit 4In person or ZoomSecond preparation
- Plan for dosing day
- We encourage at least one preparation visit in person
Dosing dayVisit 5 · about 8 hoursOne 25 mg capsule of psilocybin, with two facilitators present the entire time.
You take the capsule in a private, comfortable room. Two facilitators stay with you the entire time, and a study physician is on call. You go home only after you are medically cleared, with an adult escort.
IntegrationVisit 6 · the next weekdayA session to make sense of the experience and connect it to daily life.
Extra integration sessions can be added if you need more support, and we coordinate with your outside provider.
Visit 6In person or ZoomIntegration session
- Talk through the experience
- Check for side effects
- Short questionnaires
Follow-upVisits 7–9 · 1, 4 and 6 weeks after dosingThree check-ins by video or phone to track safety, symptoms and daily functioning.
Around four weeks after dosing, a team member who was not in your sessions interviews you about your experience. The daily diary continues through week 4.
Visit 7Zoom or phone1 week after dosing
Visit 8Zoom or phone4 weeks after dosing
- Plus the experience interview
Visit 9Zoom or phone6 weeks after dosing
- End of the main study
Long-term check-insOptional · 3, 6 and 12 monthsOptional video check-ins with an independent rater later in the year.
Saying no does not affect the rest of your time in the study.
The study lasts about 8 to 9 weeks, with optional video check-ins at 3, 6 and 12 months. In total, expect about 40 to 50 hours, including the 8-hour dosing day.
What to expect on dosing day
Every dosing day is a little different. Your facilitators will go over the plan with you during preparation.
- No alcohol or cannabis from the day before until the day after dosing
- Confirm the adult who will take you home
A full day, about 8 hours. No caffeine or nicotine until the team says it's fine.
Time and compensation
Study team
Sponsor and funding
Sponsor: Yale University. This study is supported by:
- State of Connecticut, Department of Mental Health and Addiction Services (DMHAS)
- Yale University
- Brain & Behavior Research Foundationthrough a NARSAD Young Investigator Grant to Gabrielle Agin-Liebes, PhD
Study drug (psilocybin) is provided by Usona Institute.
Contact & location
Inquire about this study
Sending an inquiry does not put you in a study and does not commit you. Whether a study is a fit is decided later, in screening.
- 1Send an inquiry
- 2A team member contacts you to answer your questions and, if you'd like, do a short phone pre-screen
- 3Screening, if it looks like a fit
Clinicians: use Refer a Patient. Not sure what happens after you write? What to expect if you inquire.
Contact the study team
- Phone
- (203) 444-1795
- Location
- Enact Research Collaborative
40 Temple St., 4th Floor, Suite 4C
New Haven, CT 06510
Registry title: Safety, Feasibility, and Tolerability of Psilocybin Treatment for Individuals With Functional Impairment Related to Mood, Anxiety, Trauma and/or Addiction Symptoms: An Open-label Proof-of-concept Study. View NCT06442423 on ClinicalTrials.gov (opens in a new tab)