Psychedelic Research

Linas Juozenas

Intelligence Unleashed · Evidence, context and controlled access

A powerful altered state is not yet a proven treatment

Psychedelic research is testing whether a brief drug-induced state, delivered inside a carefully designed clinical system, can produce durable benefit. The strongest answer is neither miracle nor dismissal: some trials show meaningful symptom change; others miss their primary endpoint; biological mechanisms are plausible but not guarantees; and safety depends on screening, setting, support, follow-up and honest governance—not the molecule alone.

PsilocybinMDMANeuroplasticityClinical trialsMicrodosingLaw & ethics

MoleculeIdentity, purity, pharmacology, dose and interactions

StateAcute perception, emotion, cognition and bodily effects

ContextExpectations, relationships, environment and therapeutic method

OutcomeSymptoms, function, durability, adverse effects and real-life value

The essential correction

The intervention is a package

A psychedelic trial rarely tests a molecule in isolation. It usually combines preparation, a controlled administration day, monitoring, interpersonal support and follow-up sessions. The drug may open an unusual period of experience; what is learned, reinforced or destabilized during that period may depend partly on the surrounding system.

The biological correction

Plasticity is opportunity, not guaranteed healing

Plasticity means that a system can change. Change may be adaptive, neutral or harmful. New connections in cells, altered network organization or a reopened learning window do not specify which belief will be learned, whether symptoms will improve, or whether improvement will persist.

01 · Name the substance and the intervention

“Psychedelic” is not one pharmacological category

Public discussion often groups together compounds with different receptors, acute effects, medical histories and hazards. Research becomes clearer when the exact agent and treatment package are named.

Related compounds that should not be treated as interchangeable
Family	Examples	Central distinction
Classic serotonergic psychedelics	Psilocybin, LSD, DMT and mescaline	Acute effects are strongly linked to serotonin 5-HT2A agonism, although broader pharmacology and duration differ.¹
Entactogens	MDMA	Often grouped with psychedelics, but monoamine release and its prosocial profile create a distinct intervention.
Dissociatives	Ketamine	An anaesthetic with dissociative effects, different targets and existing regulated medical uses.
Atypical agents	Ibogaine	Long-acting, pharmacologically complex and associated with distinctive cardiac hazards.
Proposed analogues	Shorter-acting or non-hallucinogenic compounds	Designed to retain selected plasticity-related effects while changing subjective experience.

Five outcomes are commonly confused

Acute state: what occurs during drug action. Biological marker: a receptor, spine, signal or imaging change. Symptom response: movement on a clinical scale. Recovery: meaningful improvement in function and quality of life. Enhancement: performance above a healthy baseline. Evidence for one does not automatically establish the others.

02 · Do not skip the rungs

The evidence ladder from molecule to durable benefit

A compelling mechanism can justify a trial. It cannot substitute for one.

Receptors & cellsShows that a compound can trigger a biological process under controlled conditions.

Animal modelsTests circuits, behaviour and learning windows, but translation to human illness is uncertain.

Acute human physiologyMeasures brain, body and experience during or soon after administration.

Controlled clinical outcomesAsks whether a prespecified endpoint differs from an appropriate comparator.

Durable real-world valueRequires longer follow-up, functioning, safety, access and performance outside the study.

The present evidence is promising but conditional

Identifiable pharmacology, preclinical plasticity and controlled clinical signals justify rigorous development. They do not establish universal trauma release, broad IQ gains, guaranteed spiritual truth or safe self-treatment.

03 · Mechanism with boundaries

Cells can become more changeable without knowing what should change

The modern plasticity story is scientifically important precisely because it can be stated without turning cellular adaptation into a cure narrative.

Drug reaches targetsReceptor binding changes cellular signalling
Excitability shiftsCortical communication and prediction are altered
Plasticity pathwaysGenes, growth factors and cytoskeleton may respond
Connections adaptSpines, synapses and network use may change
Experience supplies contentContext and learning shape what is reinforced
Outcome is testedSymptoms, function and harms determine value

Preclinical findings

In cultured neurons and animal models, several psychedelics have promoted neurite growth, synaptogenesis and related markers of structural and functional plasticity.² In mice, a single psilocybin exposure was followed by rapid growth of dendritic spines in frontal cortex, with a portion of the changes persisting beyond the acute period.³ Other work reported direct binding of psychedelics to the BDNF receptor TrkB at experimentally relevant sites, offering one possible route through which plasticity could be facilitated.⁴

Rodent studies have also reported reopening of a social-reward learning critical period, with the duration related to the drug’s acute time course.⁵ That finding is a model of learning sensitivity—not evidence that an adult human trauma history has been erased or that every reopened window is beneficial.

The “open window” has two directions

If learning becomes unusually flexible, supportive evidence-based work might help new responses form. Misleading interpretation, coercion, chaotic surroundings or repeated fear might also be learned more strongly. The mechanism increases the importance of context and ethics; it does not make context automatically therapeutic.

04 · Brain change across time

Acute desynchronization, context sensitivity and uncertain durability

Human imaging reveals reproducible disruptions of ordinary network organization, but colourful maps remain measurements—not photographs of insight.

Acute reorganization

High-resolution longitudinal mapping found that psilocybin produced widespread acute changes in functional connectivity, substantially larger than those seen with methylphenidate in the same research programme.⁶ A 2026 international mega-analysis found a broad tendency toward lower connectivity within large-scale networks and higher connectivity between them, alongside considerable heterogeneity across drugs, datasets and regions.⁷

After the acute state

A 2026 study followed 28 healthy adults through their first high-dose psilocybin experience using EEG, fMRI and diffusion imaging. It detected acute functional changes and one-month anatomical or connectivity-related differences associated with psychological measures.⁸ The design is valuable but small, involves carefully screened healthy volunteers and cannot establish clinical benefit or population-wide permanence.

Context can organize the acute brain state

Recent work suggests that psychedelics do not merely create random disorder: shared sensory and interpersonal context can align aspects of brain activity across participants.⁹ This strengthens a practical conclusion already familiar to clinicians—what a person sees, hears, expects and receives from others may become part of the intervention.

A scan can show: a measured signal changed. It cannot prove alone: recovery, wisdom or the truth of an interpretation.

05 · Depression

Encouraging effects, negative primary endpoints and a moving regulatory programme

Psilocybin research in depression is neither an empty trend nor a settled treatment. Different trials answer different questions.

How several influential depression trials fit together
Study	Design and result	Responsible interpretation
Raison et al., 2023	A randomized, multiblinded trial in major depressive disorder found a significant reduction in depression severity after a single psilocybin session compared with niacin, with follow-up across six weeks.¹⁰	A meaningful controlled signal, not proof of universal response, long-term safety or superiority to every established treatment.
Goodwin et al., 2022	In treatment-resistant depression, one higher-dose group improved more than a very-low-dose comparator at three weeks, while adverse events and suicidal behaviour required attention.¹¹	Supports further development while emphasizing dose, follow-up and pharmacovigilance.
Carhart-Harris et al., 2021	Psilocybin and escitalopram were compared within two treatment packages. The prespecified primary depression outcome did not show a significant between-group difference; several secondary measures favoured psilocybin.¹²	Secondary patterns are hypothesis-generating; the trial did not prove broad superiority to antidepressant care.
EPISODE, 2026	Among 144 adults with treatment-resistant depression, response at six weeks—the primary endpoint—did not differ significantly among the 25-mg, 5-mg and nicotinamide conditions. Secondary symptom changes suggested potential benefit, while safety signals were recorded.¹³	An inconclusive trial with clinically interesting secondary evidence, not a positive primary-outcome trial.
COMP360 phase 3 programme	Company announcements in 2025–2026 reported positive primary endpoints and longer follow-up in two phase 3 studies, alongside a rolling US application process.¹⁴	Important late-stage information, but company-reported top-line results are not equivalent to peer-reviewed full datasets or FDA approval.

These studies also differ in preparation, monitoring, psychotherapy and follow-up. Some require medication changes, which can affect symptoms, safety and who can enrol. Prescribed treatment should never be stopped to pursue an unsupervised experience.

Read the endpoint before the headline

A primary endpoint is chosen in advance to reduce selective interpretation. When it is negative, promising secondary outcomes may justify further research—but they should not be presented as if the trial met its main test. Conversely, one negative trial does not erase every positive signal. Scientific progress comes from the complete pattern.

07 · Beyond depression and PTSD

Small fields can be promising without being ready for general use

Disease, compound and protocol must remain attached to one another.

Cancer-related distress

Two influential randomized studies in people with life-threatening cancer reported sustained reductions in depression or anxiety after a supported psilocybin session.¹⁵¹⁶ The results are meaningful, but samples were selected, support was intensive and existential distress is not identical to every depressive disorder.

Alcohol use disorder

A randomized trial found that psilocybin-assisted psychotherapy reduced the percentage of heavy drinking days compared with active placebo plus psychotherapy over the prespecified follow-up.¹⁷ Replication, treatment-component analysis and longer-term outcomes remain important.

Alcohol is ethanol: a psychoactive, intoxicating and dependence-producing drug. Its legal familiarity does not make alcohol harmless, and acknowledging its harms does not make psilocybin or any other drug harmless.

Ibogaine

Reports and early studies have motivated research in opioid and other substance-use disorders, but ibogaine has a distinct and serious cardiac profile. Human pharmacology work documents QT-interval prolongation, which can create dangerous arrhythmia risk.¹⁸ It should not be treated as a longer version of psilocybin or as an unsupervised detoxification tool.

Do not transfer success between diagnoses

A result in cancer-related distress does not prove efficacy for bipolar depression. A result in alcohol use disorder does not prove treatment of opioid dependence. A finding with MDMA cannot be assigned to psilocybin. Each condition requires its own endpoint, comparator, contraindications and evidence.

06 · PTSD and MDMA

Strong phase 3 symptom signals met unresolved questions about evidence and delivery

MDMA-assisted therapy is a useful case study in why promising efficacy, ethical conduct and regulatory confidence must all be established.

What the trials found

Two multicentre phase 3 trials reported that MDMA-assisted therapy reduced PTSD symptoms and functional impairment more than therapy with placebo under their protocols.¹⁹²⁰ These studies represented years of development and offered hope for people with severe illness.

MDMA is not a classic serotonergic psychedelic. Its acute effects on arousal, fear, social processing and monoamine signalling create a different therapeutic and medical profile.

Why approval did not follow

In June 2024, an FDA advisory committee reviewed the application and voted against the evidence being sufficient on efficacy and risk-benefit questions.²¹ In August 2024, the sponsor reported receiving a complete response letter requesting an additional phase 3 trial rather than approval.²²

Concerns discussed around the programme included functional unblinding, the therapy component, adverse-event assessment, therapist conduct and whether the available data supported safe real-world implementation.

Regulatory lesson

A medicine and its human delivery system may need to be evaluated together

When the acute state makes participants vulnerable and interpersonal support is central, training, supervision, boundary protection, documentation and complaint pathways are not optional accessories. They are part of the benefit-risk question.

08 · Cognitive enhancement

Insight, flexibility, creativity and intelligence are different achievements

An experience can feel profound while working memory, judgement and response accuracy are acutely impaired.

Creativity

Idea fluency, originality and self-reported insight are different outcomes. Novel feeling does not guarantee value or truth.

Flexibility

Task switching, emotional avoidance and network change do not automatically equal broad rationality.

Intelligence

A general IQ increase requires broad, durable transfer after recovery; current evidence does not establish it.

In a controlled study of creativity, psilocybin increased spontaneous insights during the acute state while reducing deliberate task-based creativity; a later assessment found more novel ideas on some measures.²³ Another small open-label depression study reported increases in cognitive and neural flexibility, but those changes were not simply equivalent to antidepressant response.²⁴

The feeling of truth is not a truth test

Emotional certainty, unity, vivid imagery and a sense of revelation are experiences. A factual claim still needs observation, logic, external evidence and—in high-stakes cases—independent verification. Integration should help a person examine meaning without pressuring them to literalize every image or accept a facilitator’s worldview.

Intelligence and expertise remain indispensable

General intelligence matters for learning, abstraction, detecting contradiction and anticipating consequences. Expertise adds organized knowledge and trained perception. Wisdom adds values, experience and self-correction. No altered state manufactures years of knowledge or makes an exceptional mind replaceable.

Intelligent and original people deserve safety, autonomy, health, uninterrupted thinking time, fair credit and collaborators who test rather than appropriate their ideas.

A useful sequence: record the insight → return to ordinary sleep and orientation → identify the testable claim → seek disconfirming evidence → consult relevant expertise → judge by consequences, not intensity.

09 · Small amounts, large claims

Microdosing has not earned its productivity mythology

The word covers inconsistent substances, amounts, schedules and expectations. A barely perceptible exposure is not automatically inactive, standardized or safe for repeated use.

Expectancy is part of the result

In a large self-blinding citizen-science study, participants improved on several psychological measures whether they received microdoses or placebo; between-group differences were not significant, and expectancy or broken blinding explained much of the pattern.²⁵

Detectable does not mean beneficial

A double-blind study using psilocybin mushrooms found noticeable subjective and EEG effects but no evidence of improved well-being, creativity or cognitive function.²⁶ More recent controlled programmes continue to refine the question, but broad, reliable enhancement has not emerged as a settled finding.

Repeated low exposure also raises a different safety question from one or two supervised sessions. Long-term cardiovascular, psychiatric and interaction risks require direct study rather than extrapolation from acute full-dose trials.

No universal microdose exists

Mushroom material varies in active content; illicit or informal products may be misidentified or contaminated; individual sensitivity and concurrent medicines differ. This article therefore does not provide a dosing schedule. Research-grade exposure under a protocol is not equivalent to an unverified product used repeatedly in ordinary life.

10 · Evidence under unusual conditions

Why psychedelic trials are exceptionally difficult to interpret

The very features that make the intervention distinctive also make ordinary blinding and attribution difficult.

Functional unblinding. Participants and staff can often infer assignment from dramatic acute effects.
Expectancy. Media attention, hope, therapist enthusiasm and prior experience can change outcomes.
Comparator choice. Waitlists, inactive placebos, low doses, active placebos and established treatments answer different questions.
Support confounding. Preparation, hours of attention and integration may contribute independently or interact with the drug.
Selective samples. Trials often exclude people at higher psychiatric or medical risk, limiting generalization.
Medication changes. Tapering or stopping existing treatment can alter symptoms and enrolment.
Subjective endpoints. Depression and trauma scales are valuable but vulnerable to expectations and rater effects.
Multiplicity. Many secondary outcomes increase the chance of an attractive positive finding.
Short follow-up. A rapid response does not establish durable recovery, relapse prevention or rare delayed harms.
Commercial and allegiance effects. Sponsor, therapist and model commitments require transparency and independent replication.

Methodologists have emphasized that expectancy and inadequate blinding can inflate apparent effects in psychedelic randomized trials.²⁷ Better studies may use active comparators, blinded independent raters, assessment of treatment guesses, prespecified estimands, objective or functional outcomes, longer follow-up and transparent adverse-event collection.

Test the blind

Ask participants, therapists and raters which condition they believe occurred and how confident they are. This does not solve unblinding, but makes it visible.

11 · Risk is substance-, person- and context-specific

Low toxicity is not the same as low total risk

Physiological toxicity, psychological destabilization, impaired judgement, interaction risk and vulnerability to other people are separate dimensions.

Acute effects

Headache, nausea, dizziness, anxiety, panic, confusion and cardiovascular changes can occur.

Destabilization

Persistent insomnia, mania-like or psychosis-like symptoms, suicidality and perceptual disturbance require attention.

Situational harm

Impaired judgement can contribute to falls, driving injury, unsafe decisions, disclosure, manipulation or assault.

A systematic review and meta-analysis of therapeutic psilocybin trials found higher rates of acute headache, nausea, anxiety, dizziness and blood-pressure fluctuation than comparators, while emphasizing limited evidence on rare and longer-term harms.²⁸ The 2026 EPISODE trial illustrates why systematic collection matters: most events were acute, but dosing-day suicidal ideation was somewhat more frequent in the higher-dose condition, and a serious persistent-perception reaction occurred.¹³

During impairment

No driving, machinery, contracts, sexual consent, money transfers or irreversible decisions. A sitter does not erase impairment.

After difficulty

Persistent severe anxiety, insomnia, mania-like or psychosis-like symptoms, suicidality or loss of function requires qualified assessment—not stronger exposure.

Alcohol and combinations

Alcohol can worsen judgement and coordination; legality does not make ethanol neutral.²⁹ Combining drugs multiplies uncertainty.

12 · Current status

Legal landscape on September 3, 2026

Research permission, compassionate access, state-regulated services, prescribing authority and national marketing approval are different legal categories. Laws can change quickly; local advice must be current.

Selected jurisdictions—what exists and what it does not mean
Jurisdiction	Status on September 3, 2026	Important boundary
United States—federal	Psilocybin, LSD and MDMA remain federally controlled. FDA issued final psychedelic-drug trial guidance in July 2026.³⁰³¹	Trial guidance is not product approval.
Oregon	A state system licenses facilitators, centres, manufacturers and laboratories; administration occurs under supervision at licensed centres.³²	A state service model is neither federal approval nor take-home prescribing.
Colorado	Colorado operates a state-licensed natural-medicine programme.³³	State authorization neither cancels federal law nor proves efficacy.
Australia	Authorised specialist psychiatrists may access unapproved MDMA for PTSD and psilocybine for treatment-resistant depression under strict requirements.³⁴	The products remain unapproved and access is condition-specific.
Canada	Practitioners may request restricted drugs through the Special Access Program for serious conditions when conventional options failed, are unsuitable or unavailable.³⁵	Authorization is case-specific, not broad approval or a trial bypass.
European Union	Research proceeds under the EU Clinical Trials Regulation and national drug law; there is no blanket EU marketing authorization.³⁶	Trial or ethics approval does not permit general sale.
Lithuania	Lithuanian authorities state that illegal acquisition or possession of a small quantity has been a criminal misdemeanour since January 1, 2017.³⁷	Classification, quantity and conduct matter; verify current Lithuanian law.

Decriminalization, legalization and medical authorization are not synonyms

Decriminalization may reduce or change penalties for specified conduct. Legalization or regulation creates permitted activities under rules. Medical authorization permits a defined product, prescriber, patient group or research protocol. A city resolution, state programme or exceptional-access decision cannot be summarized safely as “psychedelics are legal.”

13 · Vulnerability requires governance

Consent, touch, interpretation, power and fair access

Ethics is not a soft supplement to efficacy. In an altered state, it is part of safety and therefore part of whether the treatment works.

Consent continues

Preparation should explain uncertainty, alternatives, recording, emergencies, costs, confidentiality and aftercare. Prior consent does not authorize every action during impairment; touch and disclosure may still be refused.

No manufactured dependence

No spiritual ownership, loyalty demands, isolation, sexual contact, financial solicitation or use of private disclosures for influence. Vulnerability is never consent.

Touch is specific and revocable

Advance discussion, narrow purpose and a real non-touch option are essential.³⁸ ³⁹

Interpretation stays voluntary

Support may examine meaning; it should not implant memories, literalize symbols or pressure religion, diagnosis or life decisions.

Institutional safeguards

Clinical competence, supervision and independent complaint channels.
Clear roles when research, therapy, prescribing and business overlap.
Privacy for recordings, biomarkers and personal narratives.
Emergency plans and continuity of care.
Transparent data, authorship and financial conflicts.
Access that does not reserve experimental hope only for wealthy clients.

Consensus guidance places consent, safety, therapist conduct, culture, equity and policy at the centre of care.³⁸ Respect for Indigenous knowledge also requires reciprocity, benefit sharing and ecological care—not branding alone.

Autonomy under altered consciousness

The person may become more open without becoming public property

They do not owe the research team a revelation, the therapist affection, the company a testimonial, the group conformity or the world access to their private experience. Returning to supportive people should feel like a celebration of agency—not surrender of individuality.

14 · What comes next

Better compounds will not remove the need for better science

The next phase is likely to diversify rather than converge on one universal psychedelic treatment.

Shorter and more controllable states

Researchers are testing compounds and delivery routes with shorter time courses. Shorter sessions could reduce burden and cost, but speed may alter the psychological process and does not automatically improve safety.

Non-hallucinogenic analogues

Preclinical work has produced molecules intended to retain plasticity-related or antidepressant-like effects without a classic psychedelic response.⁴⁰ These remain development hypotheses. If such agents succeed, they may clarify which outcomes require subjective intensity and which do not.

Precision without determinism

Future studies may combine clinical history, pharmacokinetics, physiology, digital follow-up and biomarkers to predict benefit or risk. A prediction tool should support judgement, not classify a person as destined to heal, relapse or respond spiritually.

A stronger research agenda

Larger multisite trials with clinically realistic participants.
Active comparators matching attention and treatment burden.
Direct tests of preparation and support models.
Independent raters and treatment-guess measures.
Function, relapse and quality of life—not scales alone.
Long follow-up, registries and complete adverse-event reporting.

15 · A reader’s verification tool

Use the EVIDENCE check before believing a headline

Restore the coordinates that marketing removes.

E — Exact agentDrug, formulation, purity and duration

V — VolunteersDiagnosis, exclusions, experience and sample

I — InterventionPreparation, support and follow-up

D — DesignComparator, blind and primary endpoint

E — EffectMagnitude, uncertainty and function

N — Negative findingsNull outcomes and adverse events

C — Continuity & conflictsDurability, sponsor and model allegiance

E — External checkFull paper, regulator and current law

“Psilocybin rewires the brain” is incomplete. Name the sample, time point, measure, comparator, uncertainty and link—if any—to clinical function.

16 · Correct the story, not only the statistic

Myths worth retiring

“Natural means medically safe.”Origin does not determine purity, interactions, psychological risk or legality; mushroom species can also be misidentified.

“Neuroplasticity proves healing.”Plasticity permits change; learning, context and biology determine direction.

“One trip cures trauma.”Some improve rapidly; others do not or relapse. Intensity alone does not validate trauma recovery.

“Microdosing reliably raises productivity.”Controlled studies have not established a broad, dependable cognitive advantage over placebo.

“Positive secondary outcomes make a trial positive.”Secondary findings matter, but a missed primary endpoint must remain visible.

“State reform means medical approval.”A state service or reduced penalty is not marketing authorization.

“Therapists can interpret the experience for you.”Support should not impose memory, diagnosis, spirituality or irreversible decisions.

“Psychedelics make intelligence unnecessary.”Knowledge, foresight and ethical judgement matter more when experience feels unusually convincing.

17 · The whole picture

Research deserves hope disciplined by measurement

Psychedelic drugs can produce striking changes in experience and measurable changes in cells and brain networks. Several clinical programmes have found rapid symptom improvement under carefully controlled conditions. The same literature contains negative primary endpoints, uncertain durability, functional unblinding, difficult delivery questions and safety signals that cannot be edited out of the story.

The responsible path is not prohibition of thought or commercialization of certainty. It is precise language, better comparators, long follow-up, transparent adverse-event reporting, strong consent, independent oversight and respect for the intelligence of participants. A treatment should ultimately be judged not by how extraordinary the session felt, but by whether the person becomes safer, freer, healthier and better able to live.

Evidence library

Sources and further reading

Foundational pharmacology, primary studies, randomized trials, methodological work and official regulatory sources supporting this guide.

Nichols. Psychedelics (2016).
Ly et al. Psychedelics promote structural and functional neural plasticity (2018).
Shao et al. Psilocybin induces rapid and persistent growth of dendritic spines in frontal cortex in vivo (2021).
Moliner et al. Psychedelics promote plasticity by directly binding to BDNF receptor TrkB (2023).
Nardou et al. Psychedelics reopen the social reward learning critical period (2023).
Siegel et al. Psilocybin desynchronizes the human brain (2024).
Girn et al. An international mega-analysis of psychedelic drug effects on brain circuit function (2026).
Lyons, Spriggs, Carhart-Harris et al. Human brain changes after first psilocybin use (2026).
Stoliker et al. Psychedelics align brain activity with context (2026).
Raison et al. Single-dose psilocybin treatment for major depressive disorder: A randomized clinical trial (2023).
Goodwin et al. Single-dose psilocybin for a treatment-resistant episode of major depression (2022).
Carhart-Harris et al. Trial of psilocybin versus escitalopram for depression (2021).
Mertens et al. Efficacy and safety of psilocybin in treatment-resistant major depression: The EPISODE randomized clinical trial (2026).
Compass Pathways. Second phase 3 COMP360 primary-endpoint results (company report) (2026).
Ross et al. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer (2016).
Griffiths et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer (2016).
Bogenschutz et al. Percentage of heavy drinking days following psilocybin-assisted psychotherapy vs placebo in alcohol use disorder (2022).
Knuijver et al. Pharmacokinetics and pharmacodynamics of ibogaine in opioid use disorder (2024).
Mitchell et al. MDMA-assisted therapy for severe PTSD: A randomized, double-blind, placebo-controlled phase 3 study (2021).
Mitchell et al. MDMA-assisted therapy for moderate to severe PTSD: A randomized, placebo-controlled phase 3 trial (2023).
FDA. Advisory committee meeting on midomafetamine for PTSD (2024).
Lykos Therapeutics. Complete response letter for midomafetamine capsules (company announcement) (2024).
Mason et al. Spontaneous and deliberate creative cognition during and after psilocybin exposure (2021).
Doss et al. Psilocybin therapy increases cognitive and neural flexibility in patients with major depressive disorder (2021).
Szigeti et al. Self-blinding citizen science to explore psychedelic microdosing (2021).
Cavanna et al. Microdosing with psilocybin mushrooms: A double-blind placebo-controlled study (2022).
Muthukumaraswamy, Forsyth & Lumley. Blinding and expectancy confounds in psychedelic randomized controlled trials (2021).
Yerubandi et al. Acute adverse effects of therapeutic doses of psilocybin: A systematic review and meta-analysis (2024).
NIAAA. Alcohol and the brain: An overview (2026).
FDA. Psychedelic drugs: Final clinical-investigation guidance (2026).
DEA. The Controlled Substances Act and federal drug scheduling (2026).
Oregon Health Authority. Oregon Psilocybin Services (2026).
Colorado DPO. Colorado Natural Medicine Program (2026).
TGA. Prescribe MDMA or psilocybine: Authorised psychiatrists (2026).
Health Canada. Special Access Program requests involving psychedelic-assisted psychotherapy (2026).
EMA. EU Clinical Trials Regulation (2026).
Lithuanian Drug, Tobacco and Alcohol Control Department. Drug-control legal context (2026).
McGuire et al. Ethics and policy framework for psychedelic clinical care (2024).
Aicher et al. Ethics of touch and non-touch in psychedelic-assisted therapy (2026).
Cameron et al. A non-hallucinogenic psychedelic analogue with therapeutic potential (2021).

Educational note: This article explains research, regulation and ethical principles. It does not provide instructions for obtaining, preparing, dosing or combining controlled substances and does not replace medical, psychiatric or legal advice. Product identity, individual health, medicines and local law materially change risk.

Continue exploring

Return to the Intelligence Unleashed hub

Back to blog