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Home/Research/5-MeO-DMT/Healthy Volunteers

5-MeO-DMT for Healthy Volunteers

11 papers and 7 clinical trials exploring 5-meo-dmt as a treatment for healthy volunteers.

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
IndicationApproximately 300 million people affected by depression worldwide.

Healthy Volunteers

Research involving healthy volunteers has expanded to investigate the therapeutic potentials of various psychedelics for mental health conditions. Recent findings, emphasizing compounds like psilocybin and DMT, illustrate a promising future for psychedelic-assisted therapies.

Full Healthy Volunteers profile

Academic Research

11 papers
Open Accessmeta

A systematic review of the pharmacokinetics of classical serotonergic psychedelic compounds in healthy adult subjects

This systematic review (s=32) of healthy adult volunteers examined the pharmacokinetics of LSD, psilocybin, DMT, mescaline and 5-MeO-DMT. It found that LSD and psilocybin showed dose-related peak levels, while oral and intravenous DMT differed in ways that may matter clinically.

Published
May 29, 2026
Journal
Journal of Psychopharmacology
Authors
Hampsey, E., Martin, K., Kalfas, M., Benson, L., Wihlborg, S., Jelen, L., Young, A. H., Rucker, J.
Paywallindividual

A phase 2 uncontrolled, open-label study of intranasal BPL-003 (5-methoxy-N,N-dimethyltryptamine) in patients with treatment-resistant depression

This 12‑week, open‑label Phase IIa trial of a single 10 mg intranasal dose of 5‑MeO-DMT (BPL‑003) in patients (n=12) with treatment‑resistant major depressive disorder, found that the drug was generally well tolerated with mostly mild–moderate adverse events and rapid discharge readiness (median ~98 minutes). A rapid and sustained mean MADRS reduction of 12–13 points was observed from Day 2 through Day 85, with most participants meeting response criteria and several achieving remission, supporting further evaluation in larger controlled trials.

Published
February 27, 2026
Journal
Journal of Psychopharmacology
Authors
Roberts, C., Seynaeve, M., Ermakova, A. O., Dunbar, F., Wells, H., Puri, A., Bird, C., Rucker, J. J.
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.
Open Accessindividual

Mapping the phenomenology of intranasal 5-MeO-DMT in psychedelic-naïve healthy adults

This Phase I double-blind placebo-controlled trial (n=32) using microphenomenology interviews found that intranasal 5-MeO-DMT produced dose-dependent subjective effects with rapid onset peaking at 8-15 minutes and return to baseline by 45-60 minutes, characterised by minimal visual effects but strong emotional and bodily experiences, including emotional breakthroughs and personal insights.

Published
November 6, 2025
Journal
Scientific Reports
Authors
Ermakova, A. O., Dunbar, F., Seynaeve, M., Millière, R.
Open Accessindividual

Complex slow waves in the human brain under 5-MeO-DMT

This naturalistic EEG study (n=29) examines the effects of inhaled synthetic 5-MeO-DMT (12mg) on brain activity in healthy individuals. It finds that 5-MeO-DMT radically reorganises low-frequency neural activity flows, making them incoherent, heterogeneous, and nonrecurring. It also causes broadband activity to exhibit slower, more stable, low-dimensional behaviour with increased energy barriers to rapid global shifts.

Published
August 1, 2025
Journal
Cell Reports
Authors
Blackburne, G., Mcalpine, R. G., Fabus, M., Liardi, A., Kamboj, S. K., Mediano, P. A. M., Skipper, J. I.
Open Accessindividual

Evaluation of the peak experience scale as a rapid assessment tool for the strength of a psychoactive experience with 5-MeO-DMT

The three-item Peak Experience Scale (PES) reliably and rapidly measures the strength of 5‑MeO‑DMT experiences, showing dose-related increases, a single PCA component explaining 83.5% of variance, high internal consistency (α = 0.896) and strong correlations with established measures (MEQ-30, EDI, 5D-ASC) but not the CEQ. The authors conclude the PES could be used to gain fast insight into psychedelic intensity in individual patients and to guide dose and re-dose decisions for rapid-acting psychedelics.

Published
June 2, 2025
Journal
Frontiers in Psychology
Authors
Reckweg, J. T., Mason, N. L., Theunissen, E. L., Svendsen, C. B., Terwey, T. H., Ramaekers, J. G.

Clinical Trials

7 trials
RecruitingPhase I

Acute Effects of Intravenous 5-MeO-DMT in Healthy Participants

This Phase I, randomised, quadruple-masked, placebo-controlled, parallel trial (n=40) will assess the acute subjective, physiological and pharmacokinetic effects of intravenous 5-MeO-DMT in healthy adult participants. The study compares single ascending infusion rates of 5-MeO-DMT (0.2, 0.4, 0.6, 0.8 mg/min administered intravenously over 30 minutes) against a saline placebo, with the primary focus on change in subjective effects over time. Participants aged 25–65 who meet eligibility criteria will attend three on-site visits over approximately two weeks (screening, study drug administration, and a follow-up about one week later). Participants are randomised to one of four active dose arms or placebo and are blinded to assignment. During the administration visit blood pressure and heart rate are monitored regularly, blood samples are collected via an intravenous catheter for pharmacokinetic analyses, and subjective effect scales are completed repeatedly from 1 hour 5 minutes before dosing to multiple time points after dosing (assessment window up to 245 minutes, including timepoints up to 180 minutes post-dosing). Key exclusions include current or past major psychiatric disorder, certain cardiovascular conditions, recent heavy hallucinogen use, pregnancy or breastfeeding, and other standard safety-related criteria.

Started
March 31, 2026
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT07444788
Not yet recruitingPhase I

Effects of 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) administered by intramuscular injection on frequency oscillatory power bands in healthy adults

Single-blind, non-randomised, single-group repeated-measures study (n=15) testing IM 5‑MeO‑DMT (3, 6, 9 mg) and saline placebo across four sessions to assess MEG/fMRI markers and wellbeing.

Started
September 1, 2023
Type
interventional
Blinding
single
Randomized
No
Registry ID
ACTRN12623000884606
CompletedPhase I

Safety and Pharmacokinetics of GH002 in Healthy Volunteers

Double-blind, placebo-controlled, randomised single-dose cohorts (n=64 across cohorts A–G) and an open-label multiple-dose cohort (J) investigating safety and serum pharmacokinetics of IV GH002 (5‑MeO‑DMT) in healthy volunteers.

Started
March 1, 2023
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT05753956
CompletedPhase I

Pharmacokinetics, Safety, and Tolerability of Intramuscular 5-MeO-DMT in Healthy Volunteers

This double-blind, placebo-controlled trial (n=54) will administer 5-MeO-DMT intramuscularly in varying doses (single 0.5–13 mg and multiple-dose combinations) in healthy adults to assess pharmacokinetics, safety, and tolerability.

Started
December 27, 2022
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT05698095
CompletedPhase I

Single Ascending Dose Study With BPL-003 in Healthy Subjects

Randomised Phase I single ascending-dose intranasal study (n=62) evaluating safety, tolerability and pharmacokinetics of BPL-003 (5‑MeO‑DMT) in healthy adults.

Started
February 14, 2022
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT05347849
CompletedPhase I

Pharmacokinetics of GH001 in Healthy Volunteers

Randomized, double-blind, placebo-controlled single-dose and open-label multiple-dose Phase I study in healthy volunteers (n=46) assessing inhaled GH001 (5‑MeO‑DMT) at 6, 12 and 18 mg for pharmacokinetics, safety and psychoactive effects.

Started
June 21, 2021
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT05163691

Explore further

Search all 5-MeO-DMT papers Search all Healthy Volunteers trials Full 5-MeO-DMT profile Full Healthy Volunteers profile