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Home/Research/MDMA/Healthy Volunteers

MDMA for Healthy Volunteers

74 papers and 59 clinical trials exploring mdma as a treatment for healthy volunteers.

Compoundempathogen

MDMA

MDMA is a synthetic empathogen that enhances monoamine release, producing prosocial and anxiolytic effects without frank hallucinosis. Two Phase III trials demonstrated significant PTSD symptom reductions, though FDA review raised concerns about blinding, durability, and safety characterisation.

Full MDMA 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

74 papers
Open Accessindividual

Comparison of acute effects of 3,4-methylenedioxymethamphetamine (MDMA) with and without a supplemental booster dose in healthy participants: a double-blind, randomized, placebo-controlled, crossover study

This double-blind, randomised, placebo-controlled crossover study (n=25) in healthy volunteers found that a 60 mg MDMA booster dose given 2 hours after 120 mg MDMA prolonged the subjective drug effects, but did not increase peak effects. Adverse effects were more common after both MDMA conditions than after placebo.

Published
June 4, 2026
Journal
Translational Psychiatry
Authors
Humbert-Droz, M., Becker, A. M., Valenta, J., Rudin, D., Luethi, D., Vukalovic, I., Eckert, A., Liechti, M. E., Mueller, L.
Open Accessindividual

Blinding integrity in psychedelic research: Evidence from a comparative randomized controlled trial of psilocybin, MDMA, and methylphenidate in healthy volunteers

This double-blind randomised controlled trial (n=120) in healthy volunteers assessed how well blinding held when people received psilocybin, MDMA, or methylphenidate as an active placebo, and found blinding was generally insufficient. Functional unblinding was highest for psilocybin, moderate for MDMA, and lowest for methylphenidate.

Published
May 28, 2026
Journal
European Neuropsychopharmacology
Authors
Belinger, L., Rieser, N., Engeli, E., Becciolini, L., Clamote, M., Pribis, M., Saissi, F., Florineth, G., Hehl, N., Herdener, M., Preller, K.
Open Accessindividual

Acute dose-dependent effects of 4-bromo-2,5-dimethoxyphenethylamine (2C-B) compared with 3,4-methylenedioxymethamphetamine (MDMA) and psilocybin in a double-blind, placebo-controlled study in healthy participants

This double-blind, randomised, placebo-controlled crossover study (n=24) in healthy adults compared acute effects of 2C-B, MDMA and psilocybin. A 30 mg dose of 2C-B produced effects similar to MDMA and some psychedelic changes, while MDMA caused the strongest cardiovascular stimulation and psilocybin caused more anxiety and unpleasant effects.

Published
April 28, 2026
Journal
Neuropsychopharmacology
Authors
Arikci, D., Borgulya, J., Straumann, I., Vizeli, P., Luethi, D., Thomann, J., Rudin, D., Vukalovic, I., Eckert, A., Liechti, M. E., Holze, F.
Open Accessmeta

Subjective and neurocognitive profiling of clinical doses of 3,4-methylenedioxymethamphetamine (MDMA) in healthy volunteers: implications for therapeutic use

This narrative review (2026) examines placebo-controlled single-dose studies of MDMA (75 to 125 mg) in healthy volunteers and finds that it acutely increases mood, empathy, trust and prosocial feelings, while causing temporary memory impairment and modest declines in motor coordination and cognitive flexibility. It also notes that post-acute fatigue and low mood can occur, and that MDMA may complicate trial blinding and expectancy in psychotherapy studies.

Published
April 8, 2026
Journal
Molecular Psychiatry
Authors
Ramaekers, J. G., Kuypers, K. P. C., Vollenweider, F. X.
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

The effect of methamphetamine and 3,4-methylenedioxymethamphetamine on peripheral endocannabinoid concentrations: a study in healthy adults

This within-subject, double-blind study (n=22) found that acute administration of methamphetamine (14 mg/70 kg) significantly lowered plasma 2-arachidonoylglycerol concentrations compared to placebo at 150-180 minutes post-administration, whilst MDMA (100 mg) did not affect endocannabinoid levels, and higher anandamide concentrations during the placebo condition correlated with disliking the 'drug effects'.

Published
October 6, 2025
Journal
Psychopharmacology
Authors
Mayo, L. M., Haggarty, C. J., Petrie, S. R., Hill, M. N., Bershad, A. K., de Wit, H., Deutch, A. Y.

Clinical Trials

59 trials
RecruitingPhase I

Acute Analgesic Effects of MDMA on Experimentally Induced Acute Pain, Hyperalgesia and Allodynia in Healthy Participants

This Phase I, randomised, triple-masked, crossover trial (n=20) will assess the acute analgesic effects of oral MDMA in healthy adults aged 18 to 75 years. It will compare MDMA 25 mg, 75 mg and 125 mg with placebo to evaluate whether MDMA reduces experimentally induced acute nociceptive pain, hyperalgesia and allodynia. Participants will receive the study drug by mouth during a validated electrical stimulation pain model in which repeated small electrical pulses are applied under the skin to produce moderate pain and secondary pain phenomena. The main outcome is periprocedural pain measured with the numerical rating scale, with the highest MDMA dose compared against the lower doses and placebo.

Started
March 9, 2026
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT07494214
RecruitingPhase I

MDMA-Assisted Therapy for Mental Healthcare Providers

This Phase I, open-label trial (n=30) will study the psychological and biological effects of MDMA-assisted therapy in mental health providers in training, with a single experimental MDMA session (120 mg initial oral dose with optional 40 mg supplemental dose 1.5–2 hours later), plus preparatory and integration sessions.

Started
September 22, 2025
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT07102576
CompletedPhase I

Comparative Acute Effects of R-MDMA and S-MDMA in Healthy Participants (R-S-)

This randomised, triple-blind, placebo-controlled Phase I crossover trial (n=24) will compare the acute effects of two enantiomers of MDMA—R-MDMA (300 mg) and S-MDMA (100 mg)—in healthy adult participants.

Started
May 1, 2025
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06905652
RecruitingPhase I

Acute Effects of MDMA Co-administration on the Response to Psilocybin in Healthy Subjects (MDMA-Psilo)

Double-blind, placebo-controlled, 4-period crossover study (n=24) testing 20 mg psilocybin and 100 mg MDMA alone and combined in healthy adults to assess subjective and autonomic effects.

Started
April 1, 2025
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06884514
RecruitingPhase I

Investigation of Psychedelic Effects in Psychoactive Substances

Triple-blind, placebo-controlled, within-subjects study (n=50) testing whether various psychoactive substances (psilocybin, ketamine, DXM, DMT, MDMA, THC) produce experiences similar to classic psychedelics across up to six single-dose sessions.

Started
February 5, 2025
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06772753
RecruitingPhase NA

Plasma Oxytocin Changes in Response to Low-dose MDMA vs. Placebo in Patients With Arginine Vasopressin Deficiency and Healthy Controls (OxyMAX)

This double-blind, placebo-controlled crossover trial (n=24) will investigate low-dose MDMA (25 mg or 50 mg) effects on oxytocin in patients with arginine vasopressin deficiency and matched healthy controls.

Started
January 1, 2025
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
NCT06789705

Explore further

Search all MDMA papers Search all Healthy Volunteers trials Full MDMA profile Full Healthy Volunteers profile