Active Studies
Research in Progress
The Cedar Institute funds multiple therapeutic pathways for neurodivergent populations — psychedelic medicine, neuroplasticity interventions, and trauma-informed protocols. Below are our active and planned studies.
"The soul never thinks without a mental image."
Aristotle · De Anima
Foundational Paper
2C-B and Neurodivergence: A Pharmacological Thesis
The scientific and theoretical foundation for the Karame Protocol and all 2C-B research funded by Cedar Institute. This paper synthesizes peer-reviewed pharmacological literature, controlled human research, and clinical theory to establish the rationale for 2C-B-assisted therapy in autistic and neurodivergent populations.
2C-B-Assisted Therapy for Neurodivergent Adults
Status: Pre-Clinical Development
The Compound
Why 2C-B?
2C-B (4-bromo-2,5-dimethoxyphenethylamine) is a synthetic phenethylamine compound first synthesized by Alexander Shulgin in 1974 and documented in PiHKAL, originally intended for use in psychotherapeutic settings. It acts primarily through mixed 5-HT2A and 5-HT2C partial agonism with additional activity at the serotonin transporter (SERT). Rickli et al. (2016) confirmed meaningful activity at 5-HT2A, 5-HT2B, and 5-HT2C receptors with a profile distinct from classical tryptamine psychedelics. The biased agonism profile (Gq vs. β-arrestin pathways) remains incompletely characterized (Jastrzębski et al., 2025).
Existing Research
What the Controlled Research Shows
The existing scientific literature on 2C-B in humans is extremely limited but growing. Four research programs represent the global frontier:
Maastricht University, The Netherlands
View Study ↗The research group led by Prof. Johannes Ramaekers and Dr. Pablo Mallaroni has produced the only controlled human experimental data on 2C-B. Mallaroni et al. (2023, Clinical Pharmacology & Therapeutics): double-blind, placebo-controlled crossover of 2C-B (20mg), psilocybin (15mg), and placebo in 22 healthy adults — 2C-B produced psychedelic alterations with significantly less dysphoria, subjective impairment, and ego dissolution than psilocybin. Doss et al. (2024, Biological Psychiatry CNNI): both compounds distort episodic familiarity via a common neurocognitive mechanism. Mallaroni et al. (2026, Molecular Psychiatry): 7T fMRI confirmed distinct brain reorganization patterns between 2C-B and psilocybin — spatiotemporal mapping of differential neural signatures. Mallaroni et al. (2022, Psychopharmacology): mapped experiential fingerprints of novel psychedelics including 2C-B in recreational user populations. Maastricht holds existing Dutch drug enforcement permits for 2C-B research.
University Hospital Basel, Switzerland
View Study ↗A Phase 1 randomized controlled trial (NCT05523401) led by Prof. Matthias Liechti: five-way crossover comparing 2C-B at three escalating doses (10mg, 20mg, 30mg) against MDMA (125mg), psilocybin (25mg), and placebo in 24 healthy participants. This study — now completed — will produce the first controlled dose-response curve for 2C-B across subjective, physiological, and endocrine measures, and the first head-to-head pharmacological comparison of 2C-B with established psychedelic and entactogenic compounds. Results anticipated 2025–2026. The 10mg dose data is directly relevant to the entactogenic range hypothesized as therapeutic for neurodivergent populations.
Papaseit et al. (2018)
View Study ↗An observational pharmacokinetic study examining 2C-B metabolism and acute effects. This provided useful safety and pharmacokinetic data but was not a controlled experimental design.
Sessa & Fischer (2015)
View Study ↗Documented underground 2C-B-assisted psychotherapy in Zurich spanning decades, with clinician reports of efficacy in treatment-resistant patients — the only published record of 2C-B's use in an actual therapeutic context (uncontrolled, retrospective).
The Cedar Institute believes this evidence base — while early — is sufficient to justify significant further investment in controlled clinical research, particularly in populations where 2C-B's unique profile may be most therapeutically relevant.
The Broader Field
A Field in Motion — But Incomplete
The psychedelic medicine movement is beginning to turn its attention to neurodivergent populations. Across four continents, researchers are investigating whether compounds that have shown promise in neurotypical populations can be adapted for the unique neurobiology of autism. The Cedar Institute tracks this work closely — because understanding the landscape is essential to identifying where the gaps remain.
Psilocybin and Autism
PSILAUT Study — King's College London (UK)
View Study ↗Led by Prof. Gráinne McAlonan, this completed case-control study (NCT05651126) examined how low doses of psilocybin (2mg and 5mg) affect brain function differently in autistic versus non-autistic adults, using fMRI and EEG. Co-funded by COMPASS Pathfinder Ltd., PSILAUT is the first study to directly test whether psilocybin's serotonin targets — principally the 5-HT2A receptor — function differently in the autistic brain.
CAMH Toronto (Canada)
View Study ↗Dr. Hsiang-Yuan Lin at the Centre for Addiction and Mental Health is conducting the first open-label clinical trial (NCT06731621) of psilocybin-assisted therapy specifically for autistic adults with treatment-resistant depression. Twenty participants receive manualized psychotherapy combined with psilocybin at a safety dose (10mg) followed by a treatment dose (25mg). Lin and colleagues also plan a study of LSD microdosing for autistic adults with alexithymia.
MDMA and Autism
Danforth et al. (2018) — MAPS/Harbour-UCLA
View Study ↗The foundational study. This double-blind, placebo-controlled pilot (NCT02008396, n=12) tested MDMA-assisted therapy for social anxiety in autistic adults. Results showed significant improvements in social anxiety and reduced avoidance behaviors. MDMA was safe and well-tolerated. Published in Psychopharmacology. This remains the only completed clinical trial of any psychedelic compound in an autistic population with published therapeutic outcomes.
University of Melbourne (Australia)
View Study ↗Dr. Gillinder Bedi is leading the largest planned psychedelic-autism trial to date — a multisite study recruiting approximately 150 young autistic adults for MDMA-assisted therapy targeting social anxiety. Australia is a uniquely favorable jurisdiction: in July 2023, the Therapeutic Goods Administration rescheduled psilocybin and MDMA to allow authorized psychiatrists to prescribe them.
Definium Therapeutics — DT402 / R(-)-MDMA
View Study ↗The only pharmaceutical company with a drug development program specifically targeting core autism symptoms with a psychedelic-class compound. DT402 is the R-enantiomer of MDMA, which maintains pro-social and empathogenic effects while potentially reducing stimulant activity, neurotoxicity, and abuse liability compared to racemic MDMA. A single-ascending dose trial in healthy volunteers was completed in October 2024. DT402 is currently in Phase 2a for autism spectrum disorder.
Japan
Keio University / Otsuka Pharmaceutical (Tokyo)
View Study ↗Dr. Hiroyuki Uchida at Keio University is conducting the first clinical trial of psilocybin therapy in Asia, focused on treatment-resistant depression. In May 2025, Keio entered a joint research agreement with Otsuka Pharmaceutical to build the infrastructure for psychedelic therapy implementation in Japan, including clinical trial design, professional training, legal frameworks, and stigma reduction.
Community Evidence
Orsini et al. (2025)
View Study ↗A survey of 233 autistic adults published in PLOS Mental Health documented knowledge, perceptions, and use of psychedelics for mental health in the autistic community, establishing both community demand and anecdotal benefit. A parallel study in Psychopharmacology (2024) reported testimonials of unity, transcendence, and improved mental health from autistic psychedelic users.
Pro-Social Behaviors Perspective
ACS Pharmacology & Translational Science (2025)
View Study ↗Perspective paper on psychedelics and pro-social behaviors in autism spectrum disorder context — examining the theoretical basis for serotonergic modulation of social cognition and empathic processing in neurodivergent populations.
The Gap
Where 2C-B Fits
The research landscape reveals a clear pattern: the field is converging on psilocybin and MDMA for autistic populations. This work is essential, and we support it.
But no researcher, university, pharmaceutical company, or nonprofit anywhere in the world is investigating 2C-B for neurodivergent populations.
The compound with the most pharmacologically differentiated profile for sensory processing and emotional regulation in autism — dose-dependent flexibility between entactogenic and psychedelic effects, preserved cognitive clarity at therapeutic doses, shorter duration of action, and a dual 5-HT2A/SERT mechanism — has received zero clinical research attention directed at the population that may benefit most from exactly these properties. The Cedar Institute was founded to close this gap.
Therapeutic Framework
The Karame Protocol
A four-domain integrative framework designed specifically for neurodivergent trauma resolution — assessing the whole person across Intellect (cognitive processing, executive function, metacognition), Emotion (affective regulation, empathy, social cognition, interoception), Spirit (meaning-making, purpose, existential coherence — secular, not religious), and Body (somatic awareness, sensory processing, physiological regulation).
Dosing Architecture
Three-Tier Dosing Architecture
The Karame Protocol employs a three-tier dosing structure that leverages 2C-B's dose-dependent pharmacological spectrum:
Tier 1 — Microdose Maintenance (1–3mg, sub-perceptual)
Administered on a defined schedule between macro-dose sessions. Maintains low-level serotonergic modulation and baseline inter-domain accessibility during integration. Hypothesized to sustain enough neurochemical flexibility for integration work without producing perceptible altered states. No controlled 2C-B microdosing data exists; characterization included in Phase 1 as exploratory arm.
Tier 2 — Entactogenic Session (10–15mg)
The primary therapeutic dose. Emotional warmth, maintained cognitive clarity, boundary softening without dissolution. Core of the Protocol — pharmacologically facilitated access to the body-emotion loop where neurodivergent trauma is encoded, with sufficient cognitive structure preserved for the individual to participate in their own integration. Four-domain guided work occurs within therapist dyad.
Tier 3 — Psychedelic Session (20–25mg)
Reserved for participants demonstrating readiness after Tier 2, whose therapeutic process indicates deeper processing is needed. Not mandatory. Not first-line. Dose escalation is a collaborative clinical decision informed by Tier 2 response data and ongoing K4DA assessment.
This three-tier architecture respects sensory sensitivity and cognitive rigidity by not beginning at full psychedelic intensity, provides pharmacological continuity between sessions, and leverages 2C-B's dose-dependent spectrum in a way no other compound in the current pharmacopoeia permits with the same granularity and tolerability.
Our Approach
How We Work
The Cedar Institute does not handle controlled substances or conduct clinical research directly. We follow the operational model established by the Beckley Foundation, the Usona Institute, and MAPS (now Lykos Therapeutics): we fund research conducted at university partners that hold existing DEA Schedule I researcher registrations (or equivalent national permits), IRB approvals, and established laboratory infrastructure.
We co-develop study protocols, provide funding, and ensure that findings are published and publicly accessible. This is the proven model for every major advance in psychedelic medicine research.
Measuring Impact
Primary Outcome Measures
The intervention is justified by suffering and the right to effective treatment — not by economic productivity or cognitive enhancement. Primary outcome measures include:
PTSD symptom reduction (PCL-5)
Depression severity (MADRS)
Anxiety (GAD-7)
Alexithymia (TAS-20)
Quality of life (WHOQOL-BREF)
By The Numbers
A Population in Crisis
15–20%
of the global population is neurodivergent (Doyle, 2020, British Medical Bulletin)
60%
of autistic adults report probable lifetime PTSD vs. 4.5% general population (Rumball et al., 2020)
~50%
of autistic adults meet criteria for alexithymia — difficulty identifying and describing emotional states (Kinnaird et al., 2019, European Psychiatry, weighted mean 49.93% vs. 4.89% in neurotypical controls)
n=12
the entire controlled evidence base for any psychedelic in any autistic population (Danforth et al., 2018, MDMA)
n=0
controlled studies of 2C-B in any neurodivergent population
The Path Forward
Phased Research Agenda
Phase 0 — Instrument Development (12–18 months)
Psychometric validation of the K4DA. Operationalized scoring, reliability testing, convergent validity, normative data (n≥100 per group). Autistic advisory panel convened. Publication required before clinical deployment.
Estimated cost: €100K–€200K
Phase 1 — Pilot Characterization (18–24 months)
Controlled pilot comparing acute effects of 2C-B (20mg) in autistic (n=25–30) vs. neurotypical (n=25–30) healthy volunteers using 7T fMRI, validated subjective experience measures, K4DA, and cardiovascular monitoring. Exploratory microdose arm (2mg). Leverages existing Maastricht infrastructure and Dutch regulatory approvals. DSMB oversight.
Estimated cost: €800K–€1.5M
Phase 2 — Protocol Pilot (24–36 months)
Open-label pilot of the full Karame Protocol — three-tier dosing — in 16–20 autistic adults with documented trauma history and treatment-resistant depression/anxiety. Outcomes at baseline, post-treatment, 3-month, and 6-month follow-up. DSMB oversight.
Estimated cost: €500K–€1M
Phase 3 — Controlled Efficacy
Randomized, double-blind trial vs. active placebo with matched therapeutic support. Sample size powered by Phase 2 effect sizes. Expectancy measurement and blinding assessment.
Total estimated funding through Phase 2 go/no-go decision: €1.4M–€2.7M
Follows the Beckley Foundation model — fund the delta, not the infrastructure.
Psilocybin-Assisted Therapy for Neurodivergent Trauma
Status: In Development
Study #2
Psilocybin for Neurodivergent Populations
While 2C-B offers a unique entactogenic-psychedelic profile, psilocybin remains the most clinically validated psychedelic compound — with FDA Breakthrough Therapy designation for treatment-resistant depression and active Phase 3 trials worldwide.
However, existing psilocybin research has systematically excluded autistic and neurodivergent participants. The Cedar Institute is exploring partnerships to fund psilocybin-assisted therapy trials specifically designed for neurodivergent adults with complex trauma histories.
This study would adapt existing psilocybin protocols to account for sensory sensitivities, communication differences, and alexithymia — measuring outcomes that matter to neurodivergent people rather than neurotypical baselines.
Study design and institutional partnerships are currently under development. Updates will be posted as they become available.
Non-Pharmacological Neuroplasticity Interventions
Status: Exploratory
Study #3
Beyond Psychedelics
Not all therapeutic pathways require psychedelics. The Cedar Institute is committed to funding research into non-pharmacological interventions that leverage neuroplasticity, sensory integration, and trauma-informed protocols.
One candidate modality is the Kairos Protocol — a structured intervention combining somatic experiencing, polyvagal-informed nervous system regulation, and neurodivergent-centered therapeutic frameworks. This approach targets the same domains as psychedelic therapy (emotional regulation, social connection, trauma processing) without requiring substance administration.
Other potential research directions include:
- •Sensory integration therapies adapted for autistic adults
- •Neurofeedback protocols for emotional regulation
- •Trauma-informed movement practices (somatic experiencing, dance/movement therapy)
These research directions are exploratory. The Cedar Institute will prioritize studies with the strongest theoretical foundation and community support.