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Home/Research/5-MeO-DMT/Headache Disorders (Cluster & Migraine)

5-MeO-DMT for Headache Disorders (Cluster & Migraine)

4 papers and 0 clinical trials exploring 5-meo-dmt as a treatment for headache disorders (cluster & migraine).

CompoundTryptamine

5-MeO-DMT

A potent tryptamine psychedelic known for profound mystical experiences, currently under clinical investigation for TRD and anxiety.

Full 5-MeO-DMT profile
IndicationOver 3 billion people globally.

Headache Disorders (Cluster & Migraine)

Psychedelics are being researched as potential treatments for headache disorders, including migraines and cluster headaches, which affect a significant portion of the global population. Early findings indicate that psychedelics may modulate pain perception and offer novel therapeutic pathways for those suffering from these debilitating conditions.

Full Headache Disorders (Cluster & Migraine) profile

Academic Research

4 papers
Open Accessindividual

Efficacy and Safety of the Neuroplastogen TSND-201 for the Treatment of PTSD A Randomized Clinical Trial

In a multicentre, double‑blind, placebo‑controlled phase 2 trial of 65 adults with chronic PTSD, once‑weekly oral TSND‑201 produced significantly greater reductions in clinician‑rated PTSD severity (CAPS‑5; LS mean difference 9.64, P = .01) and improvements in self‑reported symptoms, functioning and depression versus placebo. TSND‑201 was generally well tolerated — common adverse events included headache, decreased appetite, nausea, dizziness and transient blood‑pressure increases — supporting its potential as a rapid‑acting, durable treatment for PTSD.

Published
February 18, 2026
Journal
JAMA Psychiatry
Authors
Jones, A., Warner-Schmidt, J., Kwak, H., Stogniew, M., Mandell, B., Ching, T. H., Stein, M. B., Kelmendi, B.
Paywallindividual

Safety and tolerability of multiple sublingual microdoses of 5-MeO-DMT in adults with moderate symptoms of depression and/or anxiety: a randomized, double-blind, placebo-controlled study

This Phase I clinical trial (n=36) of sublingual 5-MeO-DMT (6-12 mg weekly doses over four weeks) in adults with moderate to high anxiety/depression demonstrated good safety and tolerability with no significant adverse events, rapid absorption with peak plasma concentrations at 20 minutes, dose-dependent neurophysiological modulation without full psychedelic effects, and maintenance of normal cognitive and behavioral function.

Published
July 15, 2025
Journal
Neuropsychopharmacology
Authors
Beatriz, M., Millón, B., Noguera, L., Bruno, D., Vita, L., Zanino, M., Kassuha, D. E., Ortiz, J. E., Feresin, G. E., Díaz-Dellavalle, P., Orosco, L., Garcés, M. A., Diez, P., Albarracín, S. G., Bruno, M. A.
Paywallmeta

Adverse Events in Studies of Classic Psychedelics: A Systematic Review and Meta-Analysis

This systematic review and meta‑analysis of 214 studies (3,504 participants with analysable adverse‑event data) found that high‑dose classic psychedelics were generally well tolerated in clinical/research settings, with serious adverse events occurring mainly in ~4% of participants who had preexisting neuropsychiatric disorders and no reports in contemporary trials of suicide, persistent psychotic disorder or hallucinogen‑persisting perception disorder. Common non‑serious adverse events (headache, anxiety, nausea, fatigue, dizziness) had similar prevalences for psilocybin and LSD, but substantial heterogeneity and limited systematic adverse‑event monitoring across studies highlight the need for improved pharmacovigilance.

Published
December 1, 2024
Journal
JAMA Psychiatry
Authors
Hinkle, J. T., Graziosi, M., Nayak, S., Yaden, D. B.
Paywallindividual

Phase 1, placebo-controlled, single ascending dose trial to evaluate the safety, pharmacokinetics and effect on altered states of consciousness of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine benzoate) in healthy participants

In this double-blind, placebo-controlled Phase 1 trial, intranasal BPL-003 (5‑MeO‑DMT benzoate) was well tolerated up to 12 mg and showed rapid absorption and elimination with dose‑proportional systemic exposure (Tmax ≈ 8–10 min; mean terminal half‑life <27 min) and negligible bufotenine formation. Pharmacodynamic effects scaled with plasma concentrations, producing profound, short‑lasting consciousness‑altering and mystical experiences—60% of participants had a complete mystical experience at 10–12 mg—supporting further clinical evaluation.

Published
April 14, 2024
Journal
Journal of Psychopharmacology
Authors
Rucker, J., Roberts, C. A., Seynaeve, M., Young, A. H., Suttle, B., Yamamoto, T., Ermakova, A. O., Dunbar, F., Wiegand, F.

Clinical Trials

0 trials

No clinical trials have been tagged with both 5-MeO-DMT and Headache Disorders (Cluster & Migraine) yet.

Trials are continuously being added as new studies are registered.

Explore further

Search all 5-MeO-DMT papers Search all Headache Disorders (Cluster & Migraine) trials Full 5-MeO-DMT profile Full Headache Disorders (Cluster & Migraine) profile