VA Psilocybin Trial for Veterans: The PIVOT Study Explained

What the PIVOT trial is

The Department of Veterans Affairs announced PIVOT (Psilocybin Intervention for Veterans Overcoming Treatment-Resistant Depression) on August 5, 2026. It is the VA’s first internally sponsored psilocybin clinical trial, a distinction that matters because most prior veteran-focused psilocybin research has been funded and run by private sponsors or universities, with the VA participating only as a research site.

PIVOT is a multi-site, double-blind, randomized controlled trial. It will evaluate the safety and efficacy of Compass Pathways’ COMP360 psilocybin, a synthetic, crystalline formulation the company has also studied in its own commercial Phase 3 program, specifically in a veteran population with treatment-resistant depression (TRD).

A VA spokesperson described PIVOT as one of roughly 20 active clinical trials involving psychedelic compounds currently running across the VA network, underscoring that the agency’s psychedelic research portfolio now extends well beyond this single study.

Why a VA-sponsored trial is different from a VA research site

Before PIVOT, VA medical centers had hosted psychedelic trials sponsored by outside organizations (academic centers, MAPS-affiliated researchers, and pharmaceutical sponsors) under standard VA research-hosting agreements. PIVOT is the VA itself acting as a trial partner working directly with Compass Pathways, not merely providing facilities for someone else’s protocol. That distinction affects how VA clinical leadership can use the resulting data for internal practice guidance once results are in.

Trial sites and study design

PIVOT runs at five VA medical centers. The Birmingham VA Health Care System in Alabama is the lead site, working alongside four additional locations: the Tuscaloosa VA Medical Center in Alabama, a VA site in Portland, Oregon, a VA site in the Puget Sound area of Washington State, and a VA site in Philadelphia, Pennsylvania.

The study design compares two different doses of COMP360 psilocybin in a double-blind format, meaning neither participants nor most study staff know which dose a given veteran received during the primary comparison period. Participants have the option of a second, open-label psilocybin administration four weeks after their initial dose, a design choice that lets researchers gather additional safety and response data without requiring every participant to remain on a placebo-controlled arm indefinitely.

The primary efficacy measure is depression severity, assessed with the Montgomery-Åsberg Depression Rating Scale (MADRS), a standard clinical instrument used across most modern antidepressant trials. Secondary measures include PTSD symptom severity for veterans with that co-occurring diagnosis, tolerability of side effects, and patient-reported depression outcomes.

Who can enroll

PIVOT targets veterans diagnosed with treatment-resistant depression, with or without a co-occurring PTSD diagnosis. The study plans to enroll approximately 240 veterans across its five sites, a substantially larger cohort than the roughly 80-participant VA MDMA study, reflecting COMP360’s further-along development stage and Compass Pathways’ larger commercial trial infrastructure.

Enrollment is limited to veterans able to reach one of the five host VA medical centers: Birmingham or Tuscaloosa, Alabama; Portland, Oregon; the Puget Sound area of Washington; or Philadelphia, Pennsylvania. A veteran outside those regions is not automatically eligible and should contact the nearest host site directly to ask about travel or referral options, since VA research eligibility criteria and travel-support policies vary by protocol and site.

PIVOT vs. the VA MDMA study: how they differ

Veterans and advocates sometimes conflate the VA’s two psychedelic research programs. They are separate trials with different substances, different sponsors, different sites, and different target conditions.

Both trials share a legal foundation: each operates under an FDA Investigational New Drug (IND) authorization, and both trace their political momentum to the same April 2026 executive order directing federal agencies to accelerate psychedelic research for veterans. See our VA MDMA study guide for the full detail on that separate program.

Where PIVOT fits in Compass Pathways’ broader program

PIVOT is not Compass Pathways’ only COMP360 program. The company is separately pursuing FDA approval for COMP360 in treatment-resistant depression through its own commercial Phase 3 trials, with a New Drug Application (NDA) submission targeted for the fourth quarter of 2026. That commercial track and the VA’s PIVOT trial are legally and operationally distinct: PIVOT’s multi-year timeline means it will not contribute data to Compass’s near-term NDA. A COMP360 approval decision could plausibly land years before PIVOT itself concludes.

That timing gap has a practical consequence worth naming directly: if COMP360 receives FDA approval and DEA rescheduling on the strength of Compass’s commercial trials, veterans could gain prescriber access to an approved psilocybin product through ordinary VA formulary processes well before PIVOT itself reports results. PIVOT is best understood as VA-specific confirmatory and population-focused research, not the pathway that determines whether psilocybin reaches approval at all.

Timeline and what it means for legal access

PIVOT’s federal trial registration lists a primary completion date of December 2030 and a full study completion date of June 2031, a multi-year horizon that puts this trial's own results well beyond the commercial approval timelines discussed elsewhere on this site.

• April 18, 2026: Trump executive order “Accelerating Medical Treatments for Serious Mental Illness” directs federal agencies to expand psychedelic clinical trial access for veterans.
• August 5, 2026: VA publicly announces the PIVOT trial launch.
• August 6, 2026: Compass Pathways confirms its role as COMP360 sponsor working with the VA.
• Q4 2026 (targeted): Compass Pathways plans to submit its own commercial NDA for COMP360 in treatment-resistant depression, a separate track from PIVOT.
• December 2030 (registered): PIVOT primary completion date.
• June 2031 (registered): PIVOT full study completion date.

For the current, complete state-by-state legal picture, see our legal status by state tool and the psilocybin guide.