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Project Entheos
REV 0.1
Project Entheos

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REV 0.1 · WORKING DRAFT
For trial sponsors

For trial sponsors

What this asks of a sponsor.

Project Entheos is a standard for wraparound care in regulated psychedelic trials. This page is for the people running them.

SPONSOR-FACING · REV 0.1 · NOT A COMMERCIAL OFFER

  1. It is a standard, not a service.

    There is nothing here to buy. Adopting the Code of Reciprocal Care is not a contract with Project Entheos, with its convener, or with anyone else. It is referenced the way a practice standard is referenced.

  2. Wraparound care belongs in the safety case.

    The position this project will put to the FDA is that peer support, screening and integration are part of what makes a psychedelic trial safe — not an optional addition to it. A sponsor that treats them as optional is carrying a risk it has not priced.

  3. The people who wrote it are the people who have done it.

    The Code is authored by a compensated council drawn from peer-support, harm-reduction and Indigenous-reciprocity practice. That is the source of its authority, and the reason it is worth adopting rather than approximating.

  4. It is not finished, and you can shape it.

    The standard is drafted through 2027. A sponsor with a live trial is more useful to this process now, while it can still change, than after it is published.

What adoption covers, in draft

  • §04.1Embedded peer supportPeer support specialists embedded in trial protocols alongside clinical staff, with standing equivalent to other trial personnel.
  • §04.2Integration circles, not only follow-upGroup integration circles after dosing, in addition to individual therapy follow-up rather than instead of it.
  • §04.3A harm-reduction line between sessionsA harm-reduction-trained on-call line available to participants between scheduled sessions.
  • §04.4Trauma-informed screening before dosingTrauma-informed screening protocols conducted before dosing, by staff trained to conduct them.
  • §04.5Reciprocity where the medicine comes fromA reciprocity and benefit-sharing commitment for any compound with Indigenous-medicine origins.
  • §04.6Facilitator training standardsFacilitator training standards adapted from an existing licensing framework for clinical-trial contexts.

These are a draft and will be rewritten by the Advisory Council. If you think one of them is unworkable inside a regulated protocol, that is worth telling us now — annotate it.

Fluence holds pharmaceutical contracts.

Fluence, which convenes this work, has commercial relationships with sponsors running psychedelic trials. We are stating that rather than managing around it. The governance charter will set out how those relationships are disclosed and firewalled from the council's authority.

Enquiries

Enquiries are logged. Any engagement that follows is disclosed to the Advisory Council.

Or write to partners@projectentheos.org.