A community-authored standard for psychedelic wraparound care.
Not a product. A standard.
Written with the practitioners who have kept these medicines alive for thirty years. Offered to every sponsor running a trial — sold to none of them.
Fluence convenes this work. Fluence does not own it — see §07.
Why now
Psychedelic medicine has arrived at pharmaceutical scale. The expertise it is going to need accumulated somewhere else entirely.
Eli Lilly
AtaiBeckley
Otsuka
Transcend
AbbVie
Gilgamesh compound
Three acquisitions · roughly twelve months
Three acquisitions inside roughly a year moved psychedelic drug development from venture scale to pharmaceutical scale. None of the acquiring companies has run a psychedelic trial before.
The FDA has finalised clinical trial guidance for psychedelic drug developers and scheduled a public hearing — Considerations for Potential Future Therapeutic Use of Psychedelic Drugs — for 14 September 2026 at White Oak. Nothing in that process resembles a formal channel to the practitioners who have handled these experiences outside the clinic for three decades.
The field already has a record of what that costs. In 2024 the FDA declined to approve MDMA-assisted therapy for PTSD; the Complete Response Letter, made public in September 2025, cited problems with safety reporting and trial blinding tied to underestimating participant psychology and enthusiast bias at trial sites. The sponsor lost years. This is not a story about bad actors. It is a story about a category of expertise that was not in the room.
Pharma has never run a psychedelic trial before. The people with real expertise here are the ones the industry currently distrusts.
This is not a blank page
There is no federal body making recommendations on wraparound care for regulated psychedelic medicine. But the standards work itself has been underway for thirty years — written down, published, and voluntarily adopted, largely outside federal attention.
- 1995
Council on Spiritual Practices
Code of Ethics for Spiritual Guides
Written for underground facilitators and voluntarily adopted by guides for three decades. Covers intention, informed consent, tolerance, and peer review among guides. Every code below descends from it.
- 2021
MAPS
Code of Ethics for Psychedelic Psychotherapy
Built directly on the CSP code and adapted for clinical psychedelic-assisted psychotherapy settings. Revised 2022.
- 2022
Psychedelic Association of Canada
Code of Ethics for guides
Informed consent, scope of competence, and peer review of misconduct.
- 2023
Oregon Health Authority
Psilocybin Advisory Board
The only working example of a regulator with a statutory practitioner and community advisory body. Oregon law requires the OHA to seat facilitators and service providers on a board that makes binding recommendations on rules and licensing.
The precedent to generalise
- 2024
JAMA Network Open
Ethics and policy framework consensus statement
“Developing an Ethics and Policy Framework for Psychedelic Clinical Care.” Peer-reviewed, and therefore citable in an FDA submission.
- 2026
Project Entheos
The Code of Reciprocal Care
In draft. Open for comment.
Independent research with underground practitioners keeps surfacing the same four working priorities: reciprocity over extraction, equitable access, trauma-informed screening, and dedicated preparation and aftercare. The task is not to invent a standard. It is to bring one that already exists into a regulatory process that has no way to hear it.
How it is being built
Guiding principle
Not a Fluence product. A standard, co-authored by the community, that Fluence convenes and stewards in a secretariat role — closer to how a consensus-standards body works than to how a vendor sells a service.
Founding Circle
Now → September 2026Four to six trusted voices from peer-support, harm-reduction and Indigenous-reciprocity practice, convened quickly enough to have a real voice ahead of the September hearing. A seed for the council, not a substitute for it.
Advisory Council
Q4 2026 onwardThe full governance body: compensated seats for peer-support organisations, Indigenous reciprocity representatives, independent harm-reduction voices, and clinical and academic advisors. Paid seats with real authority to set standards — not an advisory panel in name only.
The Code of Reciprocal Care
Q1 2027 onwardThe standard itself: wraparound service requirements, reciprocity and benefit-sharing commitments, screening and aftercare protocols. Co-authored by the council, published openly, and referenced the way a practice standard is referenced — not licensed, not sold.
Draft service principles
A first draft, grounded in the models above. It is meant to be argued with and substantially rewritten by the Founding Circle and the Advisory Council — not delivered to them as something already decided.
Every clause below is open. Annotate any one of them and the response is recorded against that clause, so the council can see where the disagreement actually is.
Embedded peer support
Peer support specialists embedded in trial protocols alongside clinical staff, with standing equivalent to other trial personnel.
BasisFireside Project and Zendo Project models
Integration circles, not only follow-up
Group integration circles after dosing, in addition to individual therapy follow-up rather than instead of it.
BasisTHRIVE and EMBARK frameworks; underground integration-circle practice
A harm-reduction line between sessions
A harm-reduction-trained on-call line available to participants between scheduled sessions.
BasisFireside's peer support line has handled more than 35,000 calls; roughly two-thirds of callers report de-escalating from distress
Trauma-informed screening before dosing
Trauma-informed screening protocols conducted before dosing, by staff trained to conduct them.
BasisDocumented underground practitioner priorities
Reciprocity where the medicine comes from
A reciprocity and benefit-sharing commitment for any compound with Indigenous-medicine origins.
BasisChacruna's Indigenous Reciprocity Initiative
Facilitator training standards
Facilitator training standards adapted from an existing licensing framework for clinical-trial contexts.
BasisOregon's psilocybin facilitator licensing framework
The wraparound pathway
What the six clauses amount to, in the order a participant meets them.
Calls handled by Fireside's peer support line
Roughly two-thirds of callers report de-escalating from distress.
September 14
The FDA is taking public comment on how psychedelic drugs should be regulated. We intend to be in it — and not on our own.
- 21 AUG2026
Deadline to request an oral presentation slot
- 14 SEP2026
Public hearing · FDA White Oak · hybrid
- 05 OCT2026
Deadline for written comments
What the comment will say
Name the gap. No federal mechanism brings practitioner or community expertise into psychedelic drug regulation, unlike Oregon's statutory advisory board.
Name the risk. The 2024 Complete Response Letter shows what trial design costs when it underestimates participant psychology and community dynamics.
Name the expertise. Three decades of harm-reduction and integration practice, documented in published ethics codes and in peer-reviewed research on peer support and integration outcomes.
Recommend. That the FDA convene or formally recognise a practitioner and community advisory mechanism comparable to Oregon's, and treat wraparound and peer-support services as part of the safety case for approval rather than an optional addition.
This outline has not been submitted. It needs review by the Founding Circle members whose credibility it would draw on, and by regulatory counsel, before anything is filed.
Phased implementation
Sequence matters here more than speed. Real outreach precedes public messaging at every phase.
Where this stands
Everything on this page is provisional. It is worth being exact about which parts, and why.
The Founding Circle has not been named.
Nobody has agreed to a seat yet. Nothing here should be read as the community speaking. It is one convener's opening draft, published so that it can be argued with in the open rather than settled in private.
Seats are compensated.
Community and harm-reduction advisors are paid for their time from the first meeting. Asking people to donate expertise to a process that pharmaceutical sponsors pay to participate in would reproduce the extraction this standard exists to prevent.
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.
The principles are a draft, not a decision.
The six service principles in §04 are a starting point for the council to rewrite. Comment is open on every one of them, and disagreement is the point.
The facts on this page are being verified.
Regulatory timelines, hearing procedure, and the scope of recent federal action are being independently confirmed with counsel before anything is filed with the FDA. Where we are not yet certain, this page says so rather than rounding up.
Join the founding conversation
Occasional updates, sent when something actually happens: when the Founding Circle is named, when the FDA comment is filed, and when the Code opens for public review.
Advisory Council seats are compensated. If you have done this work and want to be considered, say so — the form goes to a person, not a list.