A trauma-informed, evidence-graded protocol for psychiatric intake, C-SSRS suicide screening, psychosis/bipolar risk assessment, and genuinely informed consent before any readiness clearance decision.
Run the full C-SSRS at intake and a short version at every visit after, and treat any positive answer as an immediate escalation, not a checkbox β VHA data show most veterans who later attempt or die by suicide had screened low or moderate, not high, so "clean" today doesn't mean safe tomorrow. Ask directly about personal and family history of psychosis and bipolar disorder every single time; it's the most consistent psychological red flag across every substance in this standard, even though the field is still debating exactly how strict that exclusion should be going forward. The contraindication list gives you flags, not thresholds β you set the exact cutoff and make the go/no-go call, and no protocol overrides your judgment. And informed consent isn't a form: it's honest benefit, honest risk, honest uncertainty, delivered to someone whose psychiatric state you've actually confirmed lets them understand it.
Most people arriving at a readiness evaluation for psychedelic-adjacent care are disclosing combat exposure, sexual trauma, moral injury, or years of failed treatment β often for the first time, to a stranger. A rushed or clinically cold intake can retraumatize before you ever reach the psychiatric-risk questions you actually need answered. Framing an intake around safety, choice, and collaboration is associated with better provider recognition of PTSD and depression and higher rates of guideline-concordant, trauma-informed care delivery in primary-care trials Plausible β though that same trial found trauma-informed process improved diagnosis and care delivery without a measurable difference in 12-week symptom outcomes, so treat it as good practice, not a proven treatment effect in itself.
The Columbia-Suicide Severity Rating Scale (C-SSRS) is the field's gold-standard suicide-risk instrument, validated across adolescent and adult, psychiatric and general-medical populations Established, and it is the mandated suicide screen across the entire Veterans Health Administration. It separates two constructs that matter clinically: ideation severity (from a passive wish to be dead through active ideation with a specific plan and intent) and behavior β preparatory acts, aborted or interrupted attempts, and actual attempts, both lifetime and recent.
Administer the full C-SSRS at intake, and repeat a brief "since we last talked" screener at every subsequent contact β dosing day, daily or weekly check-ins, and every follow-up visit. This is not a one-time gate; risk changes over the course of preparation and treatment.
Across every hallucinogen-type substance covered in this standard, personal or family history of a psychotic disorder or bipolar disorder is the single most consistent psychiatric red flag for destabilization Established. Absolute risk in a monitored clinical setting is low β pooled data across contemporary psychedelic trials put psychedelic-induced psychosis at roughly 0.002% in population-based studies and 0.2%β0.6% across uncontrolled and randomized trials β but that risk concentrates sharply in people who already carry psychotic-spectrum vulnerability: in trials that enrolled participants with schizophrenia, roughly 4 in 100 went on to develop long-lasting psychotic symptoms. Serious adverse events overall β including new-onset psychosis, mania, and suicidal behavior β cluster almost entirely in participants with a pre-existing neuropsychiatric diagnosis (around 4%), versus essentially none reported in healthy volunteers.
Whether a history of schizophrenia should remain an absolute research-exclusion criterion is an open, actively studied question, and some recent meta-analytic reviews argue for a more individualized approach going forward Hypothesis β but that is a research-design debate, not a clinical green light. Until better-quality data exist, active psychosis or unmanaged bipolar disorder remains a stop point in this standard Established.
This standard flags domains; it does not set the numbers. The universal stop-framework domains are: significant or 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. The treating physician sets the exact threshold for each domain and makes the final go/no-go call β this module documents readiness, it does not clear anyone for treatment.
Medication reconciliation is where psychiatric screening and pharmacology intersect most dangerously. MDMA acts as a releasing agent at the serotonin, dopamine, and norepinephrine transporters, driving a large surge in synaptic serotonin Established. Layer an SSRI, SNRI, or MAOI on top of that and you raise the risk of serotonin syndrome β a triad of neuromuscular excitation (tremor, hyperreflexia, clonus), autonomic instability (tachycardia, hyperthermia, blood-pressure swings), and altered mental status (agitation, delirium) that can be fatal if unrecognized Established. A supervised, prescriber-directed taper β never a patient-directed one β is the standard of care before MDMA or ibogaine in a patient on serotonergic medication.
A signature is not consent. Genuine informed consent for this population requires three components delivered honestly and specifically, not as boilerplate: what benefit is realistically expected and how strong that evidence actually is; what the specific modality's signature risks are (cardiac for ibogaine, serotonergic and thermal for MDMA, bladder and dependence for ketamine, psychological destabilization risk for psilocybin and LSD, and so on); and what remains unknown, named as unknown rather than glossed over.
Be precise and current about legal and regulatory status when you disclose it β patients deserve accuracy, not the exaggerated legitimacy that hype cycles create. Psilocybin, MDMA, LSD, DMT, and ibogaine remain Schedule I under federal law; MDMA-assisted therapy has completed only Phase 3 trials and is not FDA-approved; ketamine is Schedule III and used off-label for psychiatric indications; esketamine (Spravato) is the one FDA-approved option in this space, approved specifically for treatment-resistant depression, not for the other indications sometimes discussed alongside it. Never let a patient walk away believing "in trials" means "proven" or "approved."
Assemble a clear-to-treat packet before any modality-specific step proceeds: screening results, medication reconciliation, contraindication review, the relevant modality annex, and completed education and consent. A named, licensed clinician-of-record reviews and signs it. This standard documents readiness β it does not clear anyone, and it never substitutes for your own clinic's screening and consent process.
Any safety flag β a positive C-SSRS item, a destabilization sign, a newly identified contraindication β triggers immediate escalation to the care team. It is never a data point held for the next scheduled visit.
Operation Whole Health β Patriot-founded 501(c)(3). Provider Track β prototype, DRAFT v0.1. Continuing education content; not medical, legal, or regulatory advice. Content marked Clinician sign-off is pending a named licensed physician / Medical Directorβs review before use with patients. In crisis? Veterans Crisis Line: dial 988, then press 1.