Operation Whole Health
Operation Whole Health · Readiness & Informed-Consent Standard

The Readiness Standard — Protocol v1

A universal preparation & screening framework for psychedelic and emerging therapies — one Common Core, plus a safety annex for each medicine
Covers: ibogaine · MDMA · ketamine · psilocybin · LSD · cannabis · kratom · (extensible)
Document: DRAFT v0.1 — for clinician-of-record review
What this is

One standard for every medicine

These therapies are being fast-tracked and improvised across dozens of clinics, with wildly different risk profiles and almost no shared standard for how a person is prepared before treatment. This document defines that standard — a Common Core that applies to every modality, plus a Safety Annex tailored to each medicine's specific dangers.

The architecture:
  • Part A — The Common Core: the universal spine every patient completes, regardless of medicine — Screen → Prepare → Clear-to-Treat.
  • Part B — Modality Safety Annexes: the medicine-specific risks, added screening, and interactions that plug into the core (because ibogaine's danger is the heart, MDMA's is serotonin & heat, ketamine's is the bladder & dependence, and so on).
⚑ This is a framework, not a substitute for clinical judgment. Every threshold, clearance, and go/no-go decision belongs to the patient's treating clinician. All clinical content must be finalized and signed by a named licensed physician (clinician-of-record) before use. This standard supports a clinic's own screening and consent — it never replaces them. Conflict of interest disclosed: Operation Whole Health develops nutritional prep protocols/products; the research/standards function is kept separate from the commercial one.
Evidence key: Established consistent human evidence · Plausible mechanistic/indirect · Hypothesis being studied · Clinician sign-off physician-owned.
Part A

The Common Core — applies to every modality

Phase 1 · Universal Readiness Screening Clinician sign-off Established

Baseline assessment completed and reviewed by the treating team before any of these medicines:

  • General medical: history & exam, vitals, relevant labs (metabolic, hepatic, renal), pregnancy screen where applicable.
  • Cardiovascular baseline: history, blood pressure, heart rate — several of these medicines raise BP/HR or affect rhythm2,6 (modality annexes specify ECG/QTc where needed).
  • Psychiatric: personal/family history of psychosis or bipolar disorder, and a suicidality screen — the most consistent psychological contraindications across psychedelics9,10.
  • Medication & substance reconciliation: a complete list — prescriptions, OTC, supplements, substances — screened for dangerous interactions (serotonergic drugs, QT-prolonging agents, CYP interactions)3,5.
  • Informed consent & education: confirmation the patient (and caregiver) completed the honest education and understands benefits, risks, and unknowns.

Phase 2 · Universal Preparation Plausible

  • Low-risk terrain optimization (generally beneficial regardless of outcome effect): sleep, hydration, nutrition, reduced alcohol/stimulants, and management of inflammatory/metabolic/vascular risk factors.
  • Medication adjustments — prescriber-only: some medicines require supervised tapering (e.g., serotonergic drugs before MDMA or ibogaine). This is decided and done solely by the treating prescriber, never by education or a supplement protocol.
  • Toxicant handling — test first: assess before acting; address a genuine burden conservatively and well before treatment.
  • Psychological preparation: intention, grounding, and a support circle (per the patient course); caregiver prepared (per the caregiver course).
Universal safety rule on "detox": do not reflexively chelate or aggressively detoxify. Blood-metal levels poorly predict brain levels, and chelating someone who isn't overloaded can cause lasting harm12. And aggressive detox can shift electrolytes that govern cardiac-rhythm safety — never do it near a treatment day without physician oversight.
Honest limit Hypothesis: whether optimizing the terrain improves treatment outcomes is not proven — it's an open question this standard's registry is designed to test, not a claim we make.

Phase 3 · Clear-to-Treat Handoff Clinician sign-off

A documentation packet the treating clinician reviews and signs: screening results, medication reconciliation, contraindication review, consent completed, education completed, and the relevant modality annex applied. The go/no-go decision is the treating clinician's alone — this standard documents readiness; it does not clear anyone.

Universal contraindication & stop framework thresholds physician-set

The framework flags these domains; the treating physician sets exact thresholds and decisions: significant/uncontrolled cardiovascular disease or arrhythmia; uncorrected electrolyte abnormalities; significant hepatic or renal impairment; active psychosis or unmanaged bipolar disorder; acute suicidality; pregnancy; and contraindicated concurrent medications that cannot be safely managed.

Part B

Modality Safety Annexes

Each medicine plugs its specific dangers into the Common Core. These are drafted for the clinician-of-record to verify and finalize; each carries Clinician sign-off.

Annex I — Ibogaine US Schedule I

Signature risk — the heart: blocks the cardiac hERG channel, prolongs QT, and can cause fatal arrhythmia — at therapeutic doses, even without pre-existing heart disease; risk lingers for days2,3,4. Metabolized by CYP2D6: poor metabolizers get ~2× exposure (genotype + dose-reduce)5.

Added screening/prep: 12-lead ECG with QTc; correct electrolytes (K⁺/Mg²⁺/Ca²⁺); hepatic panel; rigorous med reconciliation for CYP2D6 inhibitors (some SSRIs) and QT-prolonging drugs; continuous cardiac monitoring during treatment; magnesium loading is used in leading protocols to buffer cardiac risk1. Established

Annex II — MDMA Schedule I · late-stage trials

Signature risks — serotonin & heat: strongly serotonergic → serotonin syndrome risk when combined with SSRIs/SNRIs/MAOIs; hyperthermia and hyponatremia (over-hydration); raises blood pressure and heart rate6.

Added screening/prep: cardiovascular assessment; supervised taper of serotonergic medications by the prescriber before treatment; temperature and hydration/electrolyte management during sessions; caution in hypertension/cardiac disease. Established

Annex III — Ketamine Schedule III · legal off-label

Signature risks: acute dissociation and transient rise in blood pressure/heart rate; with repeated/higher-frequency use, urinary/bladder toxicity ("ketamine cystitis")7 and dependence/abuse potential.

Added screening/prep: cardiovascular assessment; urinary/bladder baseline and monitoring for repeated courses; substance-use/dependence screening; a plan for dissociation-related safety. Established

Annex IV — Psilocybin Schedule I · trials / some state programs

Signature risks — psychological: risk of destabilization in those with psychosis/bipolar history; transient rise in blood pressure/heart rate6; rare hallucinogen-persisting perception disorder (HPPD). In controlled trials, serious medical adverse events have been uncommon8,10.

Added screening/prep: thorough psychiatric screening; cardiovascular caution in existing disease; prepared setting and integration plan. Established (psych screening) · Plausible (favorable medical safety in controlled settings)

Annex V — LSD US Schedule I

Signature risks: very long duration (up to ~12 h) magnifying psychological demand; psychological destabilization risk in vulnerable individuals; HPPD; transient hypertension. Medical toxicity is generally low in controlled settings10.

Added screening/prep: psychiatric screening; cardiovascular caution; extended monitoring window and setting planning for the long duration. Established

Annex VI — Cannabis Schedule I federally · many states legal

Signature risks: dose-dependent increased risk of psychosis (higher with predisposition, earlier onset, worse course)9; tachycardia/cardiovascular effects; dependence; cannabinoid hyperemesis with heavy chronic use.

Added screening/prep: psychiatric screening (psychosis/bipolar/family history); cardiovascular caution; use/dependence assessment. Established

Annex VII — Kratom Unscheduled federally · varies by state

Signature risks: opioid-like activity → dependence and withdrawal, hepatotoxicity, seizures, and life-threatening toxicity (especially with other drugs)11. Not a "safe herbal" — an unregulated product with real risk.

Added screening/prep: hepatic panel (LFTs); dependence/withdrawal screening; careful drug-interaction review; honest counseling that it is unregulated and variable. Established

Extensible by design: as new modalities are fast-tracked (DMT/ayahuasca, 5-MeO-DMT, mescaline, novel analogues), each gets a new annex built to the same template — Common Core unchanged, medicine-specific safety added. That is how one standard covers the whole field.
The honest bottom line

What this standard is — and isn't

Is: a shared, evidence-graded framework so that — no matter which medicine or which clinic — a veteran is medically screened, psychiatrically assessed, medication-checked, honestly informed, and supported, before treatment. That is genuinely needed and defensible today.

Isn't: a claim that preparation improves treatment outcomes (that's a Hypothesis the registry will test), a substitute for a clinic's own care and consent, or a self-declared authority — it earns standing through a named clinician-of-record, honest evidence-grading, and outcomes data.

The registry: every prepared patient (with consent) contributes baseline → adherence → outcome data across modalities. That dataset is how the standard proves its value honestly — and it becomes the evidence engine no single clinic can build alone.

Operation Whole Health — Patriot-founded 501(c)(3). The Readiness Standard, Protocol v1 (Universal), DRAFT v0.1 — framework for clinician-of-record review; not for clinical use until physician-signed.

Disclosures & limits: Educational/organizational only; not medical advice, not a treatment protocol, and not an endorsement of any Schedule I substance or unregulated product. Several substances named here carry serious, sometimes fatal risks and varying legal status; all care and all clinical thresholds belong to qualified treating clinicians. OWH develops nutritional prep protocols/products (conflict disclosed); the standard supports — never replaces — a clinic's own screening and consent. Human evidence retrieved from PubMed; see references.

Crisis: dial 988, then press 1.

References

Sources

  1. Cherian KN, et al. Magnesium–ibogaine therapy in veterans with TBI. Nature Medicine, 2024. DOI
  2. Alper K, et al. hERG Blockade by Iboga Alkaloids. Cardiovascular Toxicology, 2016. DOI
  3. Litjens RPW, Brunt TM. How toxic is ibogaine? Clinical Toxicology, 2016. DOI
  4. Brunt TM. Ibogaine and cardiovascular complications. Addiction, 2026. DOI
  5. Glue P, et al. Influence of CYP2D6 activity on ibogaine PK/PD. J Clinical Pharmacology, 2015. DOI
  6. Johnston CB, et al. Safety & efficacy of psychedelic-assisted therapies for older adults (MDMA/psilocybin cardiovascular effects). Am J Geriatric Psychiatry, 2022. DOI
  7. Baker SC, et al. Ketamine-induced apoptosis in human urothelial cells (ketamine cystitis). American J Pathology, 2016. DOI
  8. Bogenschutz MP, et al. Psilocybin-assisted therapy for alcohol use disorder (RCT). JAMA Psychiatry, 2022. DOI
  9. Hasan A, et al. Cannabis use and psychosis: a review of reviews. Eur Arch Psychiatry Clin Neurosci, 2019. DOI
  10. Schlag AK, et al. Adverse effects of psychedelics: from anecdotes to systematic science. J Psychopharmacology, 2022. DOI
  11. Sethi R, et al. Kratom (Mitragyna speciosa): Friend or Foe? Prim Care Companion CNS Disord, 2020. DOI
  12. Smith D, Strupp BJ. The scientific basis for chelation. J Medical Toxicology, 2013. DOI
  13. Zahoor SM, et al. Neurotoxic metals & the blood–brain barrier. Vitamins & Hormones, 2024. DOI
  14. Dolenec P, et al. Psychoplastogens: neuroplasticity via BDNF-TrkB-mTOR. Pharmaceuticals, 2026. DOI