Ch. X — Therapy model, set and setting, Indigenous reciprocity

Chapter X of Post-2010 Psychedelics: An Expert-Panel Review. For the executive summary and full table of contents, start there.

Abstract. Psychedelic drug effects are not produced by the molecule alone but co-produced by molecule and context — a claim with two practical consequences for the post-2010 field. First, the clinical protocols that delivered the headline Phase 2/3 results are scaffolded experiences whose music, dyadic facilitation, room design, and integration sessions are part of the active treatment and have rarely been factorially dismantled. Second, the molecules and the experiential template both descend, by direct ethnographic lineage, from Indigenous traditions whose communities have been systematically excluded from the resulting research economy, intellectual property, and clinical revenue. This chapter treats the reciprocity question as a structural ethical claim rather than a public-relations frame.

10.1 Hartogsohn’s set-and-setting framework

The contemporary clinical formulation — that psychedelic effects are jointly determined by the user’s mindset and the surrounding environment — is most often traced to Timothy Leary’s 1961–1963 phrasing,¹ but the underlying move is older. Hartogsohn’s history of the concept² documents nineteenth-century French observations (the Club des Hashischins; Moreau de Tours) that hashish effects varied with mood and milieu, mid-twentieth-century psychotomimetic work identifying environmental modulators of LSD response (Hyde, Hoch, Cattell), and the operationalisation by Leary’s Harvard group, who argued that the great majority of what was attributed to the drug was attributable to non-drug variables. Hartogsohn extends the concept with “collective set and setting” — the cultural prior, including media narratives, drug-war framing, and clinical legitimation, that shapes any individual session’s expectancy field — and this extension is what makes the framework analytically useful for contemporary trials rather than merely historiographically useful.

The implication, which the field has been slow to internalise, is that no psychedelic clinical trial measures the unconfounded effect of a molecule. The COMP360, Lykos MDMA-AT, Imperial/Hopkins psilocybin, GH001, and BPL-003 protocols all embed a structured psychological scaffold — preparation sessions, a controlled aesthetic environment, eyeshades and headphones, a curated music playlist, one or two facilitators, post-session integration — without which the trials would not have run. What is reported as “psilocybin for treatment-resistant depression” is therefore the joint effect of molecule and manualised, expectancy-loaded therapy frame. Estric and colleagues’ 2025 systematic review catalogued the substantial heterogeneity of set-and-setting domains across published trials,³ and the ReSPCT international Delphi consensus (Nature Medicine 2025) confirmed that the basic descriptive vocabulary is not yet shared across investigator groups, proposing a 30-item reporting standard for extra-pharmacological variables.⁴ Carhart-Harris and Goodwin made the same diagnostic point in 2017: the field needs systematic refinement and manualisation of the psychological component, not less attention to it.⁵

This bears on two questions the panel will already be holding: (i) whether functional unblinding (Muthukumaraswamy et al. 2021)⁶ is a methodological flaw to be controlled, or instead a partial revelation that expectancy-and-setting variance is the active treatment; and (ii) whether non-hallucinogenic 5-HT2A agonists from the Olson and Roth programmes (Chapter III) will replicate clinical effect without the experiential template. The honest answer to (ii) is that the field does not yet know, because the experiential template has never been removed from a successful Phase 2/3 protocol.

10.2 Music in psychedelic therapy

Music is the least-examined load-bearing element of the standard protocol. The Imperial and Johns Hopkins playlists — typically five-to-seven hours of classical, ambient, and world-music selections arc-shaped to peak drug effect — were developed iteratively from the late 1990s and are now in active clinical use across most psilocybin programmes. The most-cited empirical work is from Mendel Kaelen’s group at Imperial. Their “hidden therapist” paper⁷ reported, from interpretative phenomenological analysis of 19 TRD patients in Carhart-Harris et al.’s 2016 open-label trial, that the quality of the patient’s experience of the music — not generalised drug intensity — predicted week-1 depression reduction. Earlier neuroimaging work from the same group documented that LSD modulates parahippocampal-to-visual-cortex connectivity in ways that enhance music-evoked imagery.⁸

Two caveats. First, contemporary Imperial/Hopkins playlists are dominated by Western classical and ambient choices, with limited representation of the musical traditions of the cultures from which the medicines themselves derive — a cultural specificity the playlists do not acknowledge.⁹ No controlled trial to date has factorially compared playlist origins. Second, the music-outcome relationship is correlational across the published clinical work; no programme has run a no-music or comparator-music arm at clinical scale.

10.3 Therapist training and credentialing

The post-2010 expansion has produced a credentialing patchwork rather than a profession. The major training programmes share a “preparation – experience – integration” three-phase scaffold but differ on entry credentials, hour requirements, supervision, scope-of-practice, and the contested question of whether trainees should personally experience the medicine.

• CIIS Certificate in Psychedelic-Assisted Therapies and Research (California Institute of Integral Studies, launched 2016 and the first university-affiliated programme): approximately 150 instructional hours across eight weekends plus a six-day retreat; restricted to licensed clinicians and ordained clergy/chaplains; has trained more than 1,700 professionals as of 2025.¹⁰ Until very recently no US legal pathway existed in which graduates could practise outside a clinical trial.
• MAPS / Lykos MDMA Therapy Training: dyad-centred (two cofacilitators per participant), with sequenced didactic, experiential, role-play, and supervised clinical components; the manualised model formed part of the MDMA-AT NDA package.¹¹ Lykos’s 2024 workforce reduction (see Chapter XII) has cast the long-term role of MAPS-trained dyads in doubt.
• Compass Pathways COMP360 training: a manualised “psychological support” model articulated by Goodwin and colleagues¹² — roughly ten hours of online didactic, three days of in-person practical training, plus supervised clinical training. Closer to a “minimum competency for a registered medical procedure” model than to a depth-psychotherapy training.
• Oregon Measure 109 facilitator licensure: the first state-licensed non-medical model in the US. Oregon Health Authority requires a minimum 120 hours of core didactic instruction plus 40 hours of hands-on practicum at an OHA-approved training programme, plus examination and a code of professional conduct. As of Q1 2025, 377 licensed facilitators serve 25 of 34 operational service centres.¹³

Entry credentials therefore range from doctoral-level licensure (CIIS, MAPS) to no prior healthcare credential (Oregon). Ethics codes are nascent; supervision requirements are uneven; lateral movement between systems is not standardised. The February 2023 collapse of the Synthesis Institute — the largest Oregon-pipeline training provider, which entered bankruptcy and stranded roughly 300 enrolled students¹⁴ — illustrated the financial fragility of the training-provider layer. Where the medical model is on a regulatory glide path, the credentialing infrastructure on which patient safety actually depends remains substantially undercapitalised and unsupervised.

10.4 Group versus individual session models

The default in contemporary US/UK trials is one or two facilitators per single participant — Compass uses a single therapist; MAPS used a male-female dyad; Imperial/Hopkins typically two facilitators. At six-to-eight hours of professional time per dosing session plus preparation and integration, a full course can absorb 20+ clinician-hours per patient. At an FDA-approved price point this is workable for a one-time intervention; at scale, and especially for indications requiring multiple sessions (as MDMA-AT does), it is the most consequential cost driver in the access discussion.

Group models exist. The Synthesis Institute Netherlands programme ran group psilocybin retreats with one facilitator overseeing five-to-eight participants; ayahuasca ceremonies in Indigenous and mestizo settings have always been group-based, with curanderos or padrinhos attending twenty to forty participants; Santo Daime and the UDV practise in collective settings of dozens to hundreds; the Native American Church peyote meeting is collective. Whether the therapeutic alliance the dyad model is designed to produce can be replicated by a well-held group is empirically open. Observational retreat data are uncontrolled, and group settings introduce specific risks: contagion of adverse experiences, reduced one-to-one monitoring, and documented vulnerability to charismatic-leader dynamics. The likely commercial endpoint in the US is a hybrid — individual dosing inside a clinic that runs group preparation and group integration, primarily for cost.

10.4a Cross-cultural ontology — the Western frame as one frame, not the frame

A note on epistemic positioning that the panel will press. The Western preparation–experience–integration model developed across §§10.2–10.4 is one cultural form, not a universally valid template. The dyadic Western therapy frame and the group Indigenous ceremony are not equivalent designs with different staffing ratios; they operate under different ontological assumptions about the nature of the experience. The Western frames developed in this report — psychological flexibility (Watts & Luoma 2020), predictive-processing prior-update (REBUS; Carhart-Harris & Friston 2019), Accept-Connect-Embody (ACE; Watts et al. 2017), Letheby’s naturalistic philosophy-of-mind reading (Letheby 2021) — are culturally specific theories, not neutral readings of “what the experience is.”

Alternative Indigenous epistemologies that the medical-Western framing of this report does not adopt as its primary lens, but that the field’s anthropologist-panellists will expect acknowledged:

• Shipibo-Conibo plant-teacher ontology. Ayahuasca ceremonies operate under a framing in which the Banisteriopsis caapi admixture and accompanying plants (chacruna, Psychotria viridis) are themselves agentic teachers transmitting knowledge through icaros (curative songs) sung by initiated onanyabo. The lineage transmission is through apprenticeship under master meraya/onanyabo, with the knowledge held as a community-property rather than an individual-clinician property. The Western frame’s “facilitator” role is not the equivalent of the onanyabo role.
• Mazatec velada ontology. The Mazatec velada operates within a Catholic-syncretic-Indigenous framework (post-Conquest synthesis) in which the mushrooms are los Santos Niños (the holy children) addressed liturgically; the curandera/o is in dialogue with named saints and ancestors throughout the night-long ceremony. The “set and setting” framing imported from Leary obscures this: the Mazatec velada is not a “context” for a drug effect; it is a liturgical event in which the mushrooms are participants alongside the human celebrants. The structural elements of a traditional velada are specific and not interchangeable with a Western dosing-room protocol: an opening prayer cycle drawing on Catholic liturgy (Padre Nuestro, Credo, invocation of named saints — particularly San Pedro y San Pablo for protection during the night); an altar adorned with both Catholic imagery (Virgin Mary, saints, candles) and Indigenous offerings (copal resin incense burned to purify the space and the mushrooms; flowers; cocoa; tobacco; aguardiente); the ingestion of paired sacred mushrooms by both curandera/o and patient (the curandera/o is not a sober facilitator); a structured cycle of cantos — Mazatec-language chants, sometimes incorporating Spanish, sung by the curandera/o throughout the night to propitiate the Santos Niños, diagnose illness, direct healing, and communicate with ancestors; an alternation of darkness and candlelight calibrated to ceremonial phase; a post-experience limpia (cleansing) and patient consultation in the days following. The cantos are not musical accompaniment to a drug effect; they are an integral healing instrument, transmitted through apprenticeship lineage from a teaching curandera/o. Specific velada descriptions are given by Estrada in Vida de María Sabina¹⁵ including transcripts of Sabina’s own chants (translated by Henry Munn in the 1981 English edition) and Sabina’s accounts of the post-1957 disruption: notably, her repeated statement to Estrada that after the foreign tourism wave the mushrooms “ya no son lo mismo” — “are not the same” — and that they had “lost their power” because the secrecy that bound them to the community had been broken.¹⁵ These specifics matter because they are what acknowledging the velada (rather than merely citing its existence) requires.
• Wixárika peyote pilgrimage ontology. The annual pilgrimage to Wirikuta is not a “setting” for a peyote experience; it is the embodied re-enactment of a foundational cosmological narrative, with peyote-deer-corn as an interconnected ritual triad. The “individual healing” framing of US clinical psychiatry does not translate.
• Santo Daime and UDV liturgical ontology. The Brazilian syncretic religions treat ayahuasca/Daime as a sacrament with a specific theology (Christian-Indigenous-Afro-Brazilian synthesis); ceremony is collective worship, not “psychedelic-assisted therapy.”

These framings are not adjudicated here as “pre-scientific” or as alternative-to-be-converged-with the medical-Western reading. The positive epistemological commitment this report makes is the following: Shipibo-Conibo plant-teacher ontology, Mazatec velada liturgy, Wixárika peyote cosmology, and Brazilian syncretic-religion sacramental frameworks are epistemologically legitimate knowledge systems in their own right, each governed by its own validation procedures — apprenticeship lineage, icaro transmission and community recognition of meraya/onanyabo status (Shipibo); cabildo / community ratification and inherited canto repertoire (Mazatec); pilgrimage participation and jicarero mentorship (Wixárika); recognition by recognised ecclesiastical authority within the Daimista or UDV order (Brazilian syncretism). The medical-Western frame adopted by this report is one of several legitimate explanatory systems; the report adopts it because (a) the regulatory and clinical questions a Western evidence-graded panel will assess operate within it, and (b) cross-frame translation is beyond the report’s scope and would require co-authorship that the report does not have. This is a methodological choice with epistemic consequences — specifically, the report cannot adjudicate questions that the Indigenous frames are equipped to address (the agentic role of plant teachers; the lineage transmission of healing capacity; community ratification of practitioner status; the relation between sacrament, healing, and the cosmological order). Adopting the medical-Western frame as primary is a defensible scoping choice for this audience; it is not a claim about the relative truth-content of the frames or about the convergence of the Indigenous frames toward Western pharmacology under deeper investigation.

The pragmatic implication is methodological: claims of “set and setting” as cross-cultural design variables (cf. Estric 2025 systematic review; Pronovost-Morgan / Aday et al. ReSPCT 2025 consensus) should be read as describing Western clinical set-and-setting, not a culturally neutral construct.⁴³ The ReSPCT 30-item reporting standard is a useful baseline for Western trial extra-pharmacological reporting; it does not constitute a cross-cultural reporting standard, and the panel should treat it as such.

10.5 Integration practice

Integration — structured psychological work in the days and weeks following a dosing session — is the field’s most under-theorised core component. Watts, Luoma and colleagues argue that the psychological flexibility model from Acceptance and Commitment Therapy provides the strongest theoretical scaffold,¹⁶ and the “Accept, Connect, Embody” (ACE) model derived from Watts et al.’s 2017 qualitative work on TRD patients¹⁷ is now used in Imperial-lineage protocols. Whether integration improves outcomes mechanistically — beyond serving as a harm-reduction and clinical-safety touchpoint — is harder to establish. Greń and colleagues’ 2023 review of theoretical and practical integration models for mental-health specialists¹⁸ concluded that the evidence base is informed more by clinical practice and qualitative case material than by randomised data. Bouso and colleagues’ longitudinal work on ritual ayahuasca users (Bouso et al. 2012; Jiménez-Garrido et al. 2020)¹⁹²⁰ provides indirect evidence that contextual integration in established ritual traditions correlates with durable mental-health and quality-of-life improvements, though the observational design cannot decompose set, setting, integration, and pharmacology. Aixalá and Bouso’s 2022 book-length systematisation²¹ is informed by clinical practice rather than randomised data.

An “underground integration economy” of paid integration coaches, often without licensure, has emerged alongside the clinical-trial economy. Some provide genuine continuity-of-care; others operate at the margin between therapy and spiritual coaching with no malpractice insurance and no scope-of-practice constraints. The field has not produced a credentialing standard for integration providers comparable to the dosing-session standards.

10.6 Indigenous use traditions

Specificity here is non-negotiable. Lumping the world’s Indigenous psychedelic traditions into a generic “Indigenous use” obscures both the diversity of the practices and the distinct harms suffered by distinct communities.

Mazatec mushroom practice (Mazatec people of Huautla de Jiménez, Sierra Mazateca, Oaxaca, Mexico). Psilocybe mushrooms were used in veladas — nighttime healing ceremonies — by Mazatec curanderas/os in the Sierra Mazateca long before R. Gordon Wasson’s now-infamous 13 May 1957 Life magazine article “Seeking the Magic Mushroom”²² disclosed the practice — and disclosed the identity of curandera María Sabina — to a global Western audience. Wasson had promised secrecy. Specificity matters: the Mazatec are not a singular community but a federation of distinct municipalities in the Sierra Mazateca (Huautla de Jiménez itself; San José Tenango; San Mateo Yoloxóchitl; and others), each with somewhat distinct positions on the post-1957 aftermath. CIPREPACMA (Centro de Investigación y Preservación de la Sabiduría y las Tradiciones Ancestrales del Pueblo Mazateco), referenced in §10.7, speaks for some but not all Mazatec municipalities and should be cited as the contemporary Mazatec community institution. The fallout for Sabina and the Huautla community was severe: tourism (extensively documented by Álvaro Estrada in his 1977 Vida de María Sabina, including transcripts of Sabina’s own statements and Mazatec community testimony¹⁵), federal raids, the burning of Sabina’s home, community censure for breach of secrecy, and Sabina’s own subsequent reports — in Estrada’s interviews and in Vida — that the mushrooms had “lost their power.” A post-2010 retreat-tourism wave in the Sierra Mazateca (post-How to Change Your Mind and post-Compass-Phase-3-readout) has re-disrupted the community: Huautla de Jiménez and surrounding municipalities now host a non-trivial commercial retreat economy that operates largely outside Mexican legal frameworks (Mexico’s regulatory position on Psilocybe for traditional use is ambiguous; possession remains nominally controlled but enforcement against traditional practice is limited under cultural-heritage doctrines). The episode is the canonical case study of extractive psychedelic ethnography and is taught as such within Mazatec community institutions and external scholarship.²³

Peyote (Lophophora williamsii) — Wixárika/Huichol pilgrimage and the Native American Church. Wixárika pilgrimage to Wirikuta (San Luis Potosí) is the surviving documented Indigenous peyote tradition in Mexico, involving an annual ceremonial journey of roughly 400 km and a transverse-cut harvesting practice that allows regrowth of the subterranean stem.²⁴ In the United States, the Native American Church has held a federal sacramental right under the 1994 American Indian Religious Freedom Act Amendments (Pub. L. 103-344; 42 U.S.C. § 1996a), which specifically protects “the use, possession, or transportation of peyote by an Indian for bona fide traditional ceremonial purposes” — a sui generis statutory protection that, unlike RFRA (1993), is peyote-and-NAC-specific. Peyote populations in the only US habitat (the South Texas / Tamaulipan thorn scrub) have been in documented decline since the 1980s; wild populations have been depleted by habitat conversion, mining, energy infrastructure, improper harvesting that cuts too deep into the subterranean stem rather than transverse to the crown, and demand exceeding sustainable regrowth.²⁵ The licensed-peyotero commercial regulation in South Texas (Texas Department of Public Safety / DEA-licensed distributors selling to NAC members only) is itself under post-2020 demand pressure; harvest quotas have not kept pace with NAC demand, and the price of peyote buttons has risen substantially. Crucially, supply pressure is now compounded by non-Indigenous psychedelic tourism and decriminalisation movements — a point NAC leadership has made directly to Congress and to the Decriminalize Nature movement, asking that mescaline-containing cacti be explicitly excluded from broad decriminalisation efforts.²⁶ The Indigenous Peyote Conservation Initiative (IPCI), an NAC-affiliated conservation programme, is the contemporary Indigenous-led conservation effort and operates the largest peyote-cultivation land conservancy in South Texas; the IPCI has been the principal voice asking Decriminalize Nature city ordinances and state ballot measures to exclude peyote. The pattern of city-level response has been uneven: Oakland’s 2019 ordinance covered all entheogenic plants including peyote, with subsequent friction from NAC; later ordinances (Santa Cruz; Denver, partial exclusion) and state ballot measures (notably Colorado Proposition 122) have specifically excluded peyote at NAC/IPCI request — a meaningful precedent the panel should note.

Ayahuasca — Shipibo-Conibo, Yawanawá, Asháninka, and the syncretic Brazilian religions. Banisteriopsis caapi-based brews are documented across at least seventy Amazonian Indigenous nations, with substantial inter-lineage variation in admixture plants, icaros, apprenticeship structures, and ceremonial function. The twentieth-century Brazilian syncretic religions — Santo Daime (Raimundo Irineu Serra, 1930s) and the União do Vegetal/UDV (José Gabriel da Costa, 1961) — are not Indigenous traditions in the same sense; they are mestizo-led religious movements that incorporated ayahuasca into Catholic and Afro-Brazilian syncretic frames and have themselves now globalised. Loures de Assis and Labate have documented the resulting “ayahuasca diaspora” and the legal and epistemic tensions it creates.²⁷ The “ayahuasca tourism” economy of Iquitos and Pucallpa has its own pathologies: Gearin’s anthropology documents how Shipibo healers perform a “primitivist” identity legible to Western clients, and how this distortion folds back into intra-community sorcery and capital dynamics.²⁸

5-MeO-DMT and Incilius (Bufo) alvarius (Sonoran Desert toad). This case requires plain statement, because the field repeatedly conflates it with the genuine Indigenous traditions above. There is no documented pre-Columbian Indigenous ceremonial use of I. alvarius venom for psychoactive purposes. The contemporary ceremonial practice was effectively invented in the 1980s: Ken Nelson, writing under the pseudonym “Albert Most,” produced the pamphlet Bufo alvarius: The Psychedelic Toad of the Sonoran Desert in 1984; Weil and Davis subsequently published in the scientific literature in 1994.²⁹ The “Comcáac/Seri tradition” framing now common in retreat marketing — invoking pre-Columbian lineage among the Comcáac people of the Sonoran coast in Mexico — was popularised in the 2010s by Octavio Rettig, a Mexican promoter who in the early 2010s began administering 5-MeO-DMT to people with addictions while falsely marketing it as an ancestral medicine of the Seri (Comcáac) people of Mexico; the Hermosillo-based non-profit Fundación OTAC was a key vector of the same narrative.³⁰ On the available archaeological and ethnographic evidence, this lineage claim is, in the recent journal literature, named directly as “fabricated ancestrality.”³¹ Hagerty 2020 and the broader Davis & Brown 2018 Journal of Psychoactive Drugs historical paper review the contradictory ethnographic record (Jesuit-mission documentation; Spicer’s mid-20th-century Yaqui and Comcáac fieldwork; pre-2010 Comcáac oral history) and find no support for the ancestral-use claim.³²³³ The Comcáac community has spoken publicly through the Concejo de Ancianos del Pueblo Comcáac (Council of Elders) and Tribu Comcáac press releases in 2020–2023 rejecting the appropriation and the conservation impact on their territory; these statements are the authoritative Indigenous-voice source on the misattribution and are now archived through Chacruna and the Indigenous Reciprocity Initiative.³⁴ Conservation status: Incilius alvarius is endemic to the Sonoran Desert (Arizona, USA and Sonora, Mexico); current IUCN listing is Least Concern but with documented population declines in Mexican range under harvest pressure; CITES does not currently list the species but advocacy for CITES Appendix II listing has emerged from conservation biologists. Population estimates are not well-characterised and post-2018 retreat-tourism harvest pressure (toad-medicine retreats in Mexico and the US) is the principal proximate threat. This matters not just for accuracy but because the practice has produced real conservation pressure on a single-population toad species and because Comcáac and other regional Indigenous representatives have, through formal council channels, publicly objected to the misattribution.

10.7 Reciprocity ethics — substantive treatment

The starting frame matters. The default condition of the modern psychedelic industry is extraction without reciprocity. Pharmaceutical and clinical entities have built capitalised companies on molecules first identified, characterised, and used therapeutically by Indigenous communities; Gerber et al. (2021) documented at least twenty-four registered patent processes for psilocybin and no documented legitimate reciprocal agreement between any psilocybin developer and the Mazatec community or analogous source communities.³⁵ Reciprocity is therefore not a generous addition to a neutral baseline; it is a corrective to a default of asymmetric extraction. Framing it as Western largesse — as “giving back” or “philanthropy” — concedes the very framing the underlying critique rejects.

The scholarly literature is now substantial. Labate and colleagues at the Chacruna Institute have produced a continuous body of work since the mid-2010s, including the edited volumes The World Ayahuasca Diaspora (Labate, Cavnar & Gearin 2017)²⁷ and Psychedelic Justice (Labate & Cavnar 2021),³⁶ and a 2022 Transcultural Psychiatry paper on epistemic injustices, biomedical research with Indigenous people, and the legal regulation of ayahuasca in Brazil.³⁷ Celidwen, Redvers, and an Indigenous-led international working group published in Lancet Regional Health – Americas (2022) an eight-principle framework — Reverence, Respect, Responsibility, Relevance, Regulation, Reparation, Restoration, Reconciliation — derived from consensus-building among Indigenous practitioners, lawyers, and activists across the Americas.³⁸ Williams, González Romero, Braunstein and Brant (2022) made the structural critique directly: the “psychedelic renaissance,” like the European Renaissance, is materially enabled by colonial extractivism and would not exist absent it.³⁹ Hauskeller and colleagues (2023) develop the philosophical case, identifying three modes of ongoing colonisation in psychedelic studies: extraction of Indigenous knowledge, medicalisation that strips epistemic context, and a dualism-laden idiom that re-imposes colonial categories on the very critiques meant to dismantle them.⁴⁰

Concrete practice has been mixed. The Indigenous Reciprocity Initiative of the Americas (IRI / IRIA), a programme of the Chacruna Institute, distributes pooled funds among Indigenous-led organisations across the US, Mexico, Costa Rica, Ecuador, Peru, and Brazil; the 2024 cycle supported 15 organisations across seven countries, including Wixárika peyote conservation (Hablemos de Hikuri; Wixárika Research Center), Mazatec patrimony defence (CIPREPACMA), Shipibo-Konibo medicinal-plant programmes (Alianza Arkana), and Lakota/Sioux/Nez Perce land-and-buffalo work (Buffalo Field Campaign).⁴¹ Journey Colab and a small number of other early-stage companies have publicly committed equity allocations toward Indigenous communities and therapist groups (Journey Colab’s 10% equity commitment to a Reciprocity Trust governed by Indigenous and BIPOC leaders is the substantive comparator example for commercial structures). The Psychae Institute in Melbourne has built reciprocity protocols into its research design. These are the substantive examples that exist. Set against them: the major commercial-stage developers (Compass, Lykos, atai, GH Research, MindMed, Cybin) have, to public knowledge, no equivalent structural commitments tied to revenue rather than philanthropy; none of the active patent portfolios is, to public knowledge, encumbered by a reciprocal licence obligation.

Reciprocity commitments — commercial-stage developer comparison table.

Even where most cells say “no structural commitment / philanthropy only,” the table makes the asymmetry concrete. The Journey Colab and (partly) Filament Health rows show that enforceable structures are operationally possible at small-company scale; the absence of analogous structures at the multi-billion-dollar combined valuation of Compass, atai/Beckley, GH, MindMed, and Cybin is a choice, not a constraint. Building enforceable reciprocity infrastructure at Phase-3-developer scale would require either regulatory mandate (FDA/EMA/MHRA labelling tied to documented reciprocity); contractual licence obligations encumbering specific molecule-patent portfolios; or buyer-side leverage from insurers, formularies, or government payers requiring documented reciprocity for reimbursement (a precedent that does not currently exist anywhere in the pharmaceutical sector).

Per-molecule structural-obligation accounting. The reciprocity claim is operationally generic until it is traced per molecule. The table below names the four-column accounting: each commercial-pipeline psychedelic, its documented Indigenous knowledge-transmission antecedent, the contemporary Western pharma beneficiary, and the publicly-documented reciprocity obligation tied to that specific knowledge-derivation chain. The pattern across rows is the structural finding; each row’s “documented obligation” cell is the auditable claim.

The pattern across rows: of the six commercial-pipeline categories, four (psilocybin, 5-MeO-DMT, ayahuasca/DMT, peyote/mescaline) have documented Indigenous-knowledge antecedents; for none of these has any major commercial-stage developer documented a structural obligation tied to the specific source-community knowledge-transmission chain. The peyote row is the exception that proves the rule: where the source-community position is “no commercialisation,” the structural obligation is fulfilled by the absence of a commercial pipeline — exactly because NAC and IPCI have organised to enforce this position. The other rows show what the absence of comparable Indigenous-organised pressure has produced.

Source-community voices. The cells of the per-developer comparison table and the per-molecule obligation table read as Western analysts’ verdicts; the panel will appropriately want the source communities’ own statements. Specific publicly-documented Indigenous-voice sources include:

• Mazatec (re: psilocybin commercialisation). The most direct contemporary Mazatec-authored statement on psilocybin globalisation is the essay “Mazatec Perspectives on the Globalization of Psilocybin Mushrooms” by Rosalía Acosta López, Inti García Flores (Mazatec historian, San Mateo Yoloxóchitl), and Sara Piña Alcántara, published by Chacruna and reprinted in Labate & Cavnar’s Psychedelic Justice anthology.⁴² The authors document Mazatec community framing of the mushrooms as ndi xijtho (divine medicine), not recreational substance; characterise the post-1957 disclosure as a desecration whose consequences include the “corruption of the spirit of the mushrooms”; describe the rise of “autonomous neoshamans” working for tourists and the monetisation of sacred heritage; and call on Western researchers to “create forums for dialogue” with Mazatec practitioners moving beyond folkloric extraction. CIPREPACMA (Centro de Investigación y Preservación de la Sabiduría y las Tradiciones Ancestrales del Pueblo Mazateco) is the contemporary Mazatec community-institution interlocutor referenced through the IRIA programme.
• Wixárika (re: peyote commercialisation and decriminalisation). The Wixárika Regional Council for the Defense of Wirikuta issued a 13 May 2020 statement (Tuxpan) explicitly rejecting alignment with the Decriminalize Nature movement and supporting the IPCI/NCNAC position that decriminalisation initiatives in the United States should not include peyote.⁴³ The Council clarified that IPCI and NCNAC are the only organisations with which the Wixárika have a “formal and historical” cooperative relationship and that decriminalisation efforts should not invoke Wixárika support. This is the canonical authoritative-source statement on the peyote question.
• Comcáac (Seri) (re: 5-MeO-DMT misattribution). The Concejo de Ancianos del Pueblo Comcáac (Council of Elders) and Tribu Comcáac issued public statements 2020–2023 objecting to the misattribution of 5-MeO-DMT toad practice as Comcáac/Seri ancestral medicine, archived through Chacruna and the IRI.³⁴ The 2026 International Journal of Drug Policy “fabricated ancestrality” paper documents the contemporary Comcáac position alongside historical-ethnographic evidence against the pre-Columbian-use claim.³¹
• Shipibo-Konibo (re: ayahuasca tourism). COSHIKOX (Consejo Shipibo-Konibo y Xetebo) is the apex Shipibo-Konibo political organisation and has issued position statements on cultural-heritage protection; Alianza Arkana is an additional Shipibo-Konibo-affiliated NGO documenting healers’ positions on ayahuasca tourism and exploitation. The Chacruna Institute, World Ayahuasca Diaspora anthology (Labate, Cavnar & Gearin 2017), and IRI materials archive these statements. As of the freeze date, no major IV-DMT clinical-development programme has publicly documented engagement with COSHIKOX or its affiliated bodies.
• NAC and IPCI (re: peyote conservation and decriminalisation). The Indigenous Peyote Conservation Initiative (https://www.ipci.life) maintains a public-statements page documenting NAC and IPCI positions on conservation, harvest, and decriminalisation. Their 2020–2022 testimony to Congress and to the Decriminalize Nature movement asked for explicit peyote exclusions; the pattern of city-level and state-level response (Colorado Proposition 122 excluded peyote; Oakland 2019 ordinance did not; later ordinances varied) is the operational record.

The pattern across these sources is consistent: source communities have organised positions on commercialisation, tourism, conservation, and Western research engagement; with the partial exception of the peyote/NAC case where the Indigenous position has shaped US legal architecture, the major commercial-stage psychedelic developers have not publicly documented engagement with these statements. The absence of source-community-specific statements addressing each individual commercial developer is itself a finding: the source communities have spoken to the field as a whole, and the field has not responded at the structural level the source communities have asked for.

“Psychedelic colonialism” — the term and its use. This report uses the phrases “extraction without reciprocity” and “structural reciprocity gap” rather than the term “psychedelic colonialism” that has been developed in the Indigenous-studies literature.⁴⁴ The term is substantively developed by González Romero (in Williams et al. 2022),³⁹ Hauskeller et al. (2023),⁴⁰ and contributors to the Decolonizing Psychedelics special issues. It names the structural critique made here — that the post-2010 Western psychedelic enterprise is materially enabled by and depends on continuing extraction of Indigenous knowledge, plants, and labour without proportionate redistribution — and locates it within the broader theoretical tradition of decolonial scholarship (Quijano on coloniality of power; Mignolo on epistemic decoloniality; Smith on decolonising methodologies). The report’s choice of less politically-loaded language is a scoping decision about audience (a clinical/regulatory panel for whom “colonialism” carries political resonance some readers will discount), not a substantive disagreement with the term’s analytic content. The Indigenous-studies literature uses “psychedelic colonialism” deliberately because the structural critique it names is itself political; the report’s neutralised vocabulary risks softening the critique to a degree the panel should be aware of. A reader who finds the report’s “extraction without reciprocity” framing inadequately direct should read the report’s argument as a translation of “psychedelic colonialism” into the report’s idiom, not as a different argument.

What “reciprocity” means. The term is contested in the Indigenous-led literature, and the contestation is itself part of the political content. The Celidwen 2022 eight-principle framework (Reverence, Respect, Responsibility, Relevance, Regulation, Reparation, Restoration, Reconciliation) is a consensus document produced by an Indigenous-led international working group across the Americas; it is not the only Indigenous-perspective framework. The Chacruna Institute’s IRIA operationalisation builds on Celidwen but adds specific pooled-fund mechanics. The IPCI’s peyote-specific framework operates on different parameters (conservation; community-led commercial exclusion; sacramental-use protection under AIRFA). Per-source-community standards may differ further: CIPREPACMA’s positions on psilocybin commercialisation, Wixárika Regional Council positions on peyote, COSHIKOX/Alianza Arkana positions on ayahuasca, Comcáac Council positions on 5-MeO-DMT all draw on community-specific governance traditions that consensus documents necessarily aggregate. This report uses “reciprocity” to denote structural redistributive commitments tied to revenue, equity, or contractual obligation rather than philanthropy, but the operational definition — what dollar amount per molecule per community per year over what time horizon counts as adequate — is properly determined by the source communities themselves, not by Western analysts. Consensus documents have known limitations (they aggregate inter-community variation; they typically privilege established-NGO participants over younger or non-affiliated practitioners) that further deliberation will need to address. The report’s verdict that “the gap between rhetoric and structure is presently the largest in the field’s short history” should be read precisely: by the criteria articulated in Indigenous-led frameworks (Celidwen 2022, IRIA, IPCI), the gap is real and large; alternative criteria — including criteria yet to be articulated by source communities not currently at the table — might score the gap differently or differently weight different components.

The critique to take seriously — and the one the medical anthropologist on the panel will flag — is that even well-intentioned reciprocity programmes risk reproducing the asymmetry they aim to correct. Distributing donations through Western non-profits, however well-administered, keeps decision authority in the global North; pooled funds that flow to “Indigenous-led organisations” do not necessarily reach the source communities of specific molecules; and “consultation” can function as ethics-washing if not coupled to enforceable royalty, equity, or licensing terms. The Celidwen framework is explicit on this distinction: Reparation and Restoration are separate principles from Respect precisely because relational acknowledgment without structural redistribution is insufficient. The honest summary at the freeze date is that the conceptual apparatus for genuine reciprocity exists, the commercial-stage implementation does not, and the gap between rhetoric and structure is presently the largest in the field’s short history.

10.8 The therapy-versus-decriminalisation tension

The two regulatory pathways that have emerged in the United States post-2018 produce inverted access profiles. The FDA medical pathway routes patients through prescriber referral, manualised training-credentialed facilitation, and commercial reimbursement: high-cost, narrow-indication, heavily monitored, structurally favouring insured patients with documented diagnoses. The state-licensed non-medical pathway (Oregon Measure 109; Colorado Proposition 122 — detailed jurisdiction-by-jurisdiction in Chapter XI) is lower-friction at entry and indication-agnostic, but cash-pay only and without clinical follow-up infrastructure. Decriminalisation efforts (Decriminalize Nature municipal ordinances; 2020 Oakland/Denver/Santa Cruz actions) remove criminal penalty without creating regulated access: harm-reduction goals advanced, no quality control or training requirement supplied.

Equity implications cut across these in non-obvious ways. The medical pathway is least equitable on raw access but most equitable on quality-of-care for those who reach it. The state-licensed model has broader theoretical reach but a cash-pay floor that excludes the demographics most affected by TRD and PTSD; Oregon Q1 2025 reported 1,509 clients and nine service-centre closures since early 2024, with emerging data indicating that clients skew wealthier than the state’s overall mental-health-care population.⁴⁵ Decriminalisation alone shifts the population toward those with social capital sufficient to navigate unregulated supply — again not the demographic with the highest mental-health burden.

The link back to §10.7 is direct and unflattering. The pathway that generates revenue (medical) has the weakest reciprocity practice. The pathway that most closely resembles Indigenous source practice (community-based, longer-arc, embedded in cultural context) has no commercial revenue to share. Structural reciprocity will not emerge from the medical pathway organically; it requires either regulatory mandate, contractual obligation embedded in licensing, or buyer-side leverage (insurer, formulary, or government) of a kind the field has not yet built.

Who speaks for “the field” in the regulatory and policy conversations. The demographic and cultural composition of the bodies shaping psychedelic regulation is uncritically Western and predominantly non-Indigenous. The FDA Psychopharmacologic Drugs Advisory Committee that voted against Lykos’ MDMA-AT NDA in June 2024 included no Indigenous representatives. The Oregon Psilocybin Advisory Board (the state body that drafted Measure 109 implementation rules) included clinician, harm-reduction-advocate, and academic seats with no formal Indigenous-tradition seat. The Colorado Natural Medicine Advisory Board similarly. ICER’s CEPAC panels on midomafetamine-AT and (anticipated) on psilocybin-TRD have no formal Indigenous representation. FDA Patient-Focused Drug Development consultations have included patient advocates but not source-community representatives. Chacruna, Celidwen, the Indigenous Reciprocity Initiative, and the Indigenous Peyote Conservation Initiative have not, to public knowledge, been seated on any of the registrational or policy decision bodies. The voices that do shape the regulatory conversation — Doblin (MAPS/Lykos), Goodwin (Compass), Carhart-Harris (UCSF/Imperial), Olson (UC Davis), Griffiths (Hopkins legacy), Nutt (Imperial), Pollan (popular-press), Heffter and Beckley philanthropic networks — are demographically homogeneous, predominantly white, predominantly North American/Western European, and predominantly drawn from elite institutional networks. The financial structure of the field’s advocacy (philanthropy from the Bronner family, the Steven & Alexandra Cohen Foundation, Tim Ferriss’s funding networks, etc.) parallels this composition; venture capital allocation to the listed psychedelic companies likewise. None of this is itself a critique of any individual advocate; it is a structural observation about who has standing in the regulatory conversation. Closing the representation gap requires explicit committee-seat allocation, which neither FDA nor state advisory bodies have yet implemented.

Reflexive acknowledgment of this report’s evidentiary base. The structural observation made in the preceding paragraph applies to this report as well. The evidentiary base from which this review is constructed is itself drawn primarily from the Western academic and industry sources whose demographic composition the report critiques: Carhart-Harris, Olson, Griffiths, Nutt, Doblin, Goodwin, Liechti, Vollenweider, Roth, Davis, Aday, Szigeti, Muthukumaraswamy, Yaden, Reckweg, Hauskeller, Williams, and the journal corpus they publish in. The post-2010 psychedelic-research literature is dominated by these voices, and a 55,000-word synthesis necessarily reflects that domination. The report’s structural critique of the field’s demographic composition is thereby made from within sources of that composition. A review of psychedelics audited through Indigenous-knowledge-system sources — drawing primarily on Mazatec, Wixárika, Shipibo-Konibo, NAC, and Brazilian syncretic religious authority; on Indigenous-authored scholarship (Celidwen, Acosta López, García Flores, Piña Alcántara, Palacios, Cano Tomé, and others whose work the present report cites in §10.7 only as supplements rather than as primary evidence) — would reach materially different conclusions on at least the following: the legitimacy and centrality of plant-teacher ontology as explanatory framework; the relative weight of community-validation versus clinical-trial validation as evidence standards; the proper governance of post-marketing safety data on molecules with documented Indigenous antecedents (§Y4 in the synthesis); and the framing of “vulnerable populations” as a category that excludes elders, ancestors, land, and intergenerational knowledge transmission. The report’s choice to operate within the Western-scientific evidentiary frame is a scoping decision that the panel should weigh, and one that the next generation of psychedelic-field reviews should explicitly be co-authored with practitioners and scholars from the source communities rather than merely citing them. The structural-self-criticism the decolonial methodology calls for is this one: the report critiques the field’s structure while operating within it, and the limitation is inherent to the scoping choice this report made.

References

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