LIGPATD 2 · The effectiveness trial
LIGPATD 2 Study Proposal
NUNM · Sheri Eckert Foundation
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Sheri Eckert Foundation
LIGPATD 2

Low-Income Group Psilocybin-Assisted Therapy for Depression

The effectiveness trial

We proved it can be done. Now we prove it’s worth covering.

Study Proposal · $400K – $1.2M · Three scoped tiers

Sheri Eckert FoundationResearch Incubator · funder of LIGPAT 1
NUNM
National University of Natural MedicineHelfgott Research Institute · sponsoring institution
SYNAPTIC
Synaptic InstituteClinical delivery partner

02 The result we already have

The first clinical trial run inside a state psilocybin program worked.

In 2024–25 the Sheri Eckert Foundation put $30,000 into a question nobody had answered: can group psilocybin therapy be delivered safely and affordably to low-income adults, inside Oregon’s regulated system? The answer came back in about nine months, and it was published.

Baseline
22.2HAM-D
Very severe depression
At completion
8.8HAM-D
Mild · 11.9 at three months
d = 1.89, p < .001. All eight PROMIS-29 domains improved significantly. Self-rated quality of life rose 5.9 → 7.4 out of 10. Zero serious adverse events, 4.8/5 mean participant satisfaction.
24 → 19

enrolled → completers, an open-label feasibility pilot with 95% retention among those who began treatment

$30K

total study cost, roughly $1,250 per participant, about the price of a used car

~9 mo

from funding to published results, against roughly 33 months for a typical Phase 2

0

serious adverse events across two group administration sessions per participant

Journal of Psychedelic Studies · 2026 NCT06372197 Preregistered · DEA-consulted NUNM · Synaptic · OHSU

03 The barrier

Oregon built legal access. It did not build affordable access.

Thirty-seven states have passed or are pushing psychedelic access legislation. Legality was the first gate. Price is the second one, and no state has cleared it. A program that only serves people who can write a four-figure check is not a public health program.

~$2,000
Average cost of a single psilocybin session in Oregon

Paid out of pocket. No insurer covers it, no public program reimburses it, and the people with the highest burden of depression are the least able to pay. The result is a legal program with a demographically narrow client base.

  • Depression is one of the largest sources of human suffering and roughly two-thirds of patients do not reach remission on their first treatment.
  • Affordability and non-representative participation are the two problems named most often in state access programs, and they are the same problem.
  • Oregon is cutting, not expanding. The state faces roughly $1 billion in budget pressure, with around 400,000 Oregonians at risk of losing Oregon Health Plan coverage.
  • Payers do not fund promise. They fund evidence of effectiveness and evidence of cost. Right now this field has produced the first and almost none of the second.

04 The mechanism

Group delivery is the only lever that moves the price enough to matter.

A one-to-one psilocybin session buys eight hours of two licensed facilitators’ time for one person. Cohorts of six spread that same clinician time across six people, without take-home dosing and without leaving the licensed setting. The cost curve bends, and the therapeutic content may improve rather than degrade.

The economics

Roughly 35% modeled cost reduction, and about 51% for psilocybin in major depression

Marseille, Stauffer et al., Frontiers in Psychiatry (2023), the first empirical estimate of cost savings and improved access from group psychedelic therapy. LIGPAT 1 then delivered a real cohort at about $1,250 per participant.

The clinical case

Group is not a compromised version of individual care

Group psychedelic therapy is understudied rather than disproven. The published work that exists, including psilocybin-assisted group therapy for long-term AIDS survivors (Anderson et al., 2020) and the MDMA group protocol developed by Stauffer et al. (2025), suggests the shared container can add therapeutic value, not just save money.

6

participants per cohort, the group size LIGPAT 1 ran and LIGPATD 2 keeps

2

licensed facilitators covering a full cohort rather than a single client

100%

of dosing stays inside a licensed service center with continuous in-person monitoring

~$1,250

delivered cost per participant in the completed feasibility study

05 The study

A randomized, controlled effectiveness trial.

LIGPATD 2 keeps the delivery model that worked and adds what a feasibility study cannot provide: a control arm and a health-economics arm. Medicaid-eligible Oregon adults with major depression are randomized to immediate treatment or to a standard-of-care waitlist treated after the control window.

01

Screen & randomize

Intake, medical history, in-person screening visit and informed consent with the PI. Randomization to immediate treatment or standard-of-care waitlist.

In person · NUNM
02

Two preparation sessions

Group preparation in the assigned cohort of six, run online to remove the transportation barrier that disproportionately affects this population.

Online · group of 6
03

Two administration sessions

Six to eight hours each, all six participants dosed together, continuous monitoring by licensed facilitators. No take-home dosing.

Licensed service center
04

Integration & follow-up

Group integration two to three days after each administration, then structured follow-up with the health-economics measures carried forward.

Online · then longitudinal
  • Who. Oregon adults 21+ at or below 200% of the federal poverty level with a DSM-5 diagnosis of major depressive disorder. SSRIs permitted throughout, as in LIGPAT 1.
  • Recruitment. Community mental health clinics and behavioral health providers across Oregon, plus direct referral from the Sheri Eckert Foundation’s Psilocybin Access Fund, whose waitlist now exceeds a thousand people.
  • Representation. Dedicated treatment-and-control cohort pairs for Spanish speakers, BIPOC participants, and rural participants, facilitated by similarly identifying facilitators.
PHQ-9Primary outcome · depression severity
GAD-7Anxiety
PCL-5PTSD symptoms
EQ-5D-5LFeeds QALY calculation
Cost capturePayer, patient and provider perspectives

Outcome measures collected at baseline, after each treatment, and monthly through one year post-treatment. The one-year tail is what makes the economics arm possible and what hands data forward to a utilization analysis.

06 Two aims

One trial, two answers, both required for coverage.

A payer will not act on either half alone. Effectiveness without cost data is an interesting clinical finding. Cost data without a control arm is a model, not a measurement. LIGPATD 2 produces both from the same participants, at the same time.

Aim 1 · Does it work

Effectiveness of group psilocybin therapy against standard care in a low-income population

Hypothesis: follow-up PHQ-9 scores in the psilocybin arm will be statistically and clinically significantly lower than standard-of-care scores. Powered on the effect observed in LIGPAT 1 rather than on borrowed assumptions, with attrition budgeted conservatively at 30% in the control arm.

Aim 2 · What does it save

Cost-effectiveness and budget impact against current standards of care

Cost-effectiveness analyses in this field have so far relied on economic models and post-hoc data. This one is built on cost and quality-of-life data captured prospectively inside a running trial, from the perspectives that actually decide coverage: payers, patients and providers.

Philanthropy can’t and won’t last forever. The point of this study is to build the case that this care pays for itself, so the next thousand people through the door are not waiting on a donor. The Sheri Eckert Foundation’s standing thesis for the research portfolio

07 What it unlocks

Fast answers now, and a feed into the long-term evidence base.

The intervention is short. Data starts arriving while the trial is still running, which is the opposite of the usual psychedelic-research timeline. The one-year follow-up then produces exactly the kind of longitudinal record a healthcare-utilization analysis needs, so LIGPATD 2 strengthens ORCHID rather than competing with it.

Who acts on this

State Medicaid boards and legislators

Every state weighing public coverage runs into the fiscal case first. A trial that reports cost per QALY against standard care in a Medicaid-eligible population is the artifact that conversation requires.

The leverage

Private dollars that unlock public dollars

A funded, in-flight trial is a far stronger position from which to request state matching support than a proposal is. Philanthropy here is not the funding source of record, it is the thing that makes the public ask credible.

08 Investment

Three honest tiers, from the smallest study still worth running.

This proposal exists in three developed versions, built for three different funding mechanisms. They are not a negotiation ladder. Each one answers a different question, and the cheapest one that answers your question is the one to fund.

Tier 1 · Core trial
$400K
~36 participants · 6 cohorts

The smallest design that still produces a controlled effectiveness result. Waitlist control, the full outcome battery, a lighter economics arm. Answers Aim 1 cleanly and gives Aim 2 a first real estimate.

Publishable · not yet payer-grade
Tier 2 · Full trial
$547K
72 participants · 12 cohorts · 3 years

The version with a complete line-item budget already built. Twelve cohorts of six, full health-economics arm with a dedicated health economist and biostatistician, a funded project coordinator, and a year of follow-up on every participant.

The recommended ask
Tier 3 · Multi-site
$1.2M+
75+ participants · multiple sites

Multi-site recruitment through community mental health clinics statewide, dedicated Spanish-speaking, BIPOC and rural cohort pairs, and a full budget impact analysis sized to be decision-grade for a state Medicaid board.

Built to change a coverage decision

09 Where the money goes

The Tier 2 budget, line by line.

Three years, twelve cohorts, seventy-two participants. Roughly two-thirds of this budget is people: a principal investigator at half effort, a funded project coordinator, and the licensed co-facilitators who sit with every cohort for a full dosing day.

PersonnelPI at 50% effort, project coordinator at 45%, co-investigator; salary and fringe$327,059
ConsultantsCo-facilitators at 22 clinician hours per cohort, health economist, biostatistician$58,640
Service center rental24 administration sessions, full facility for the full day, $1,500 each$36,000
PsilocybinMarket rate including state tax at maximum dose, 72 participants$14,400
Participant incentives$200 at follow-up, 72 participants$14,400
Travel, recruitment, publicationThree conferences, participant advertising, open-access fees$18,400
Institutional indirectNUNM facilities & administrative costs$77,835
Tier 2 total, three yearsDirect $468,899 · indirect $77,835$546,734

Figures are drawn from the line-item budget workbook prepared by the principal investigator. Tier 1 and Tier 3 are scoped from the corresponding grant versions of this protocol and from the PI’s own estimate of the minimum viable and decision-grade designs; both would be costed in full before submission.

10 Team & next steps

The team that already delivered this once.

LIGPATD 2 is not a first attempt. The principal investigator designed, ran, co-facilitated and published the feasibility study, inside the same regulatory framework, with the same delivery partners.

Principal Investigator
Matthew Hicks, ND, MS Postdoctoral scholar at NUNM’s Helfgott Research Institute, founder of the Synaptic Institute, and a member of the Oregon Psilocybin Advisory Board. Principal investigator and co-facilitator on LIGPAT 1, the first clinical trial conducted inside a state-regulated psychedelic program.
Institution
NUNM Sponsoring institution, IRB of record, and home of a psychedelic-assisted therapy certificate program that makes the trial a training ground for the next cohort of researchers and clinicians.
Incubator & funder
Sheri Eckert Foundation Funded and deployed LIGPAT 1 with a $30,000 catalytic grant. Brings the Psilocybin Access Fund waitlist, service center and facilitator relationships, and the fundraising for this proposal.
Delivery
Synaptic Institute & licensed service centers Clinical delivery partner on the feasibility study, alongside Oregon-licensed service centers and facilitators operating under OAR 333-333.

Fund

Underwrite a tier outright, or anchor one. A lead commitment at any tier is what converts this from a protocol into a running trial.

Connect

Introductions to funders, payers, health plans or state health authorities with an interest in the cost side of behavioral health.

Match

Commit contingent on a public match. A private commitment is the strongest possible basis for a state or institutional matching request.

Sheri Eckert Foundationinfo@sherieckert.org
Principal InvestigatorMatthew Hicks, ND, MS · NUNM