Vetted study · Verified Jun 17, 2026
Psilocybin for Treatment-Resistant Depression (PIVOT)
◷ UpcomingPsilocybinDepressionPTSD
Large multi-site VA Phase 3 psilocybin trial for veterans with treatment-resistant depression. Begins July 2026.
This study has a confirmed start but isn't enrolling yet. Check the official page for the recruitment date.
This is an interventional study — the research team administers the treatment under a controlled, IRB-approved protocol. Participation never happens outside that protocol.
★ Featured study
Microdosing Vets
Are you a combat veteran who's microdosed?
An Ethics Approved CIIS study documenting veterans' microdosing experience. Combat veterans 21–50 with a PTSD diagnosis and prior microdosing experience are needed.
- Substance
- Psilocybin
- Status
- Upcoming
- Conditions
- Depression, PTSD
- Who can join
- Veterans only
- Where
- AL · OR · PA · WA
- Run by
- VA Office of Research and Development
- Registry ID
- NCT07226232 ↗
How to join this study
Call or email the study team directly. You do not go through Psychedelic Vets — we just make the door easier to find.
Lori L Davis, MD AB
Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama
☎(205) 554-3819✉lori.davis@va.govAnchal Ghera, MS
Birmingham VA Medical Center, Birmingham, AL — Birmingham, Alabama
☎(205) 899-1273✉anchal.ghera@va.govPatricia Pilkinton, MD
Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama
☎205-554-2000✉patricia.pilkinton@va.govKaleb Murry, MS
Tuscaloosa VA Medical Center, Tuscaloosa, AL — Tuscaloosa, Alabama
☎2055542000✉kaleb.murry@va.govChristopher Stauffer, MD
VA Portland Health Care System, Portland, OR — Portland, Oregon
✉christopher.stauffer@va.govMichael Thase, MD
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA — Philadelphia, Pennsylvania
✉michael.thase@va.govRebecca Hendrickson, MD
VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington
✉rebecca.hendrickson@va.govContact details as published by the sponsor, last verified 2026-06. People move on — if this doesn't reach anyone, check ClinicalTrials.gov.
What taking part involves
You may receive a placebo.Participants are randomly assigned and neither you nor the team knows which you got. That is what makes the result trustworthy — and it means joining is not the same as being treated.
240 spotsEstimated enrollment for the whole study, across every site.
Ages 18–75
Psilocybin comparator dose
Psilocybin intervention dose
Who can join
Listed as the research team wrote them. This is not a decision about you — only the study team can say whether you are eligible, and the only way to find out is to ask them.
What the study is looking for
- Veteran of the U.S. military who is English-speaking
- Signed informed consent and HIPAA
- Adults \</= 75 years of age
- Meets DSM-5 criteria for current major depressive episode (MDE)
- MADRS \>/= 20 at baseline
- Failure to respond satisfactorily to \>/= 2 antidepressant treatments for \>/= 8 weeks, including \>/= 2 weeks at an adequate dose (\>/= 50% of the FDA-approved uppermost dose) for major depression. Augmentation with a medication for depression (e.g., neuroleptics, lithium, levothyroxine) is considered a separate course of treatment.
- If applicable, concurrent \& permitted antidepressants must be at stable doses for \>/= 4 weeks prior to baseline (see allowed \& prohibited medication list)
- Participants of child-bearing potential must have negative pregnancy test \& agree to adhere to a medically acceptable method of birth control during the study
- Has a responsible adult who will provide transportation to the participant's home or place of lodging on the days of psilocybin administration
What would rule you out
- Lifetime bipolar, schizophrenia spectrum, or other psychotic disorders
- First-degree relative with history of bipolar I, schizophrenia spectrum or other psychotic disorder
- Presence of psychotic symptoms (e.g., MDE with psychotic symptoms)
- Sedative-hypnotic, stimulant, inhalant and/or opioid use disorder within past 6 months (lifetime substance use disorder is allowed at the discretion of the LSI)
- Severe alcohol and/or cannabis use disorder within the past 6 months (mild or moderate alcohol and/or cannabis use is allowed at the discretion of the LSI)
- Lifetime hallucinogen persisting perception or hallucinogen use disorders
- Use of psilocybin, ayahuasca, mescaline, lysergic acid diethylamide (LSD), dimethyltryptamine (DMT), 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), peyote, or 3,4-methylenedioxymethamphetamine (MDMA) within past 6 months
- Participant agrees to not use psychedelics (listed above) during the study, except as prescribed by the study protocol
- Taking prohibited medication within 2 weeks of baseline (see allowed and prohibited concomitant medication list)
- History of severe traumatic brain injury (TBI)
- Diagnosis of dementia or related progressive neurocognitive disorder
- Suicidal ideation/behavior Type 4 or Type 5 intensity on C-SSRS within past 6 months of baseline
- Psychiatric inpatient treatment within past 3 months of baseline
- Treatment with electroconvulsive therapy, deep brain stimulation, vagus nerve stimulation, or transcranial magnetic stimulation within 3 months of baseline
- Implanted central nervous system device
- Treatment with evidence-based psychotherapy (EBP) for MDD or PTSD within 2 weeks prior to baseline. If receiving EBP therapy, he/she must complete treatment at least 2 weeks prior to baseline. Other forms of non-EBP psychotherapy for MDD or PTSD are allowed to continue during the study period.
- Pregnancy or lactation, or anticipated pregnancy or breastfeeding during the active treatment phase
- History of myocardial infarction, congestive heart failure, diabetic ketoacidosis, brain cancer, stroke and/or severe cardiac disease
- Clinically significant cardiac, pulmonary, renal, liver and/or other medical disease that, in the opinion of the investigator, may contraindicate the use of psilocybin, interfere with the interpretation of study results and/or constitute a health risk for the participant if they take part in the study
- Seizure disorder, except for seizures due to fever or withdrawal from a substance
- Clinically significant hypertension (\>160/95 mmHg), hypotension (\<90/60 mmHg) tachycardia (\>100 bpm at rest), QTc prolongation (\>450 msec men; \>470 msec women) or clinically significant arrhythmia on ECG
- Clinically significant abnormal laboratory results on chemistry panel, liver function tests, complete blood count, and/or thyroid stimulating hormone
- Positive urine drug screen for illicit drugs of abuse (except for THC) at screening or baseline
- Prior allergic, adverse reaction or adverse experience to a psilocybin formulation
- Litigating for disability income for a mental disorder outside the VA compensation and pension process
Go to the official study page on ClinicalTrials.gov →
You enroll directly with the research team through their own official page and IRB-approved consent process. Psychedelic Vets does not run this study or collect any of your health information.
Why this listing is here. Every study in our directory is hand-reviewed against a published set of standards — recruiting or clearly marked, registered or run by a known institution, open to U.S. veterans, and research-only (never facilitation of obtaining any substance). See how we vet →
If you're in crisis, the Veterans Crisis Line is free, confidential, and available 24/7 — you don't have to be enrolled in VA care. Dial 988, then press 1, or text 838255.
Study data is sourced from ClinicalTrials.gov (U.S. National Library of Medicine) and verified university/nonprofit sources. This page is educational and is not medical advice or an endorsement. Details can change — always confirm on the official page above. ← Back to all studies
