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Home/Research/Placebo/Medicinal Chemistry & Drug Development

Placebo for Medicinal Chemistry & Drug Development

8 papers and 5 clinical trials exploring placebo as a treatment for medicinal chemistry & drug development.

CompoundComparator / Control

Placebo

Placebo is the most widely referenced comparator in psychedelic clinical research, appearing in over 500 trials. Understanding how placebos are designed, administered, and interpreted is essential to evaluating the evidence base for psychedelic-assisted therapies — and one of the field’s most contested methodological challenges.

Full Placebo profile
IndicationOver 300 million people worldwide experience depression, with many also suffering from related anxiety disorders.

Medicinal Chemistry & Drug Development

Medicinal chemistry plays a crucial role in the development of novel psychedelic compounds, focusing on their molecular structures and interactions. Researchers utilise innovative methods to enhance safety and efficacy in psychedelic substances.

Full Medicinal Chemistry & Drug Development profile

Academic Research

8 papers
Open Accessindividual

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous RE104: A Double-Blind, Randomized, Single Ascending Dose Placebo-Controlled Study

This double-blind, randomised, placebo-controlled Phase I study (n=48) evaluates the safety, pharmacokinetics, and psychoactive effects of RE104 (psilocybin analog; Luvesilocin; a prodrug of 4-OH-DiPT) in healthy adults with prior psychedelic experience. RE104 was well tolerated up to 40 mg with no serious adverse events, and plasma levels of its active form correlated with subjective drug effect and mystical experience scores. The compound produced psilocybin-like effects with a shorter duration (3-4 hours), supporting further therapeutic investigation.

Published
July 21, 2025
Journal
Journal of Clinical Psychopharmacology
Authors
Ludbrook, G., Bryson, N., Taylor, B., Hocevar-Trnka, J., Johnson, M. W., Hirman, J., Morrish, G., Alexander, R., Pollack, M.
Open Accessindividual

Network control energy reductions under DMT relate to serotonin receptors, signal diversity, and subjective experience

This re-analysis (n=14) applies a receptor-informed network control theory framework to investigate the effects of DMT on the brain's control energy landscape. It reveals that DMT, like LSD and psilocybin, reduces global control energy, with these trajectories correlating with EEG signal diversity and subjective intensity ratings. Furthermore, the regional effects of DMT correlate with serotonin 2a receptor density, demonstrating a potential proof-of-concept for predicting pharmacological intervention effects on brain dynamics using control models.

Published
April 18, 2025
Journal
Communications Biology
Authors
Singleton, S. P., Timmermann, C., Luppi, A. I., Eckernäs, E., Roseman, L., Carhart-Harris, R. L., Kuceyeski, A.
Open Accessindividual

Pharmacokinetics and Pharmacodynamics of an Innovative Psychedelic N,N-Dimethyltryptamine/Harmine Formulation in Healthy Participants: A Randomized Controlled Trial

This secondary analysis of an RCT (n=31) evaluates a novel pharmaceutical formulation of DMT and harmine in healthy male volunteers. The study finds that intranasal DMT and buccal harmine (pharmahuasca) produce consistent pharmacokinetic profiles and safe, well-tolerated effects resembling ayahuasca, with subjective experiences lasting 2-3 hours. This formulation is proposed as a safer, standardised alternative for potential therapeutic use in mental health disorders.

Published
January 8, 2025
Journal
International Journal of Neuropsychopharmacology
Authors
Mueller, J., Mueller, M. J., Aicher, H. D., Dornbierer, D. A., Marten, L., Suay, D., Meling, D., Elsner, C., Wicki, I., Poetzsch, S. N., Caflisch, L., Hempe, A., Steinhart, C., Puchkov, M., Kost, J., Landolt, H-P., Seifritz, E., Quednow, B. B., Scheidegger, M.
Open Accessindividual

Psychological and physiological effects of extended DMT

This single-blind, placebo-controlled crossover study (n=11) investigated a novel administration method for DMT involving a bolus injection followed by a constant-rate infusion to extend the experience over 30 minutes. Results demonstrate that the method was safe and maintained stable subjective effects, although the plateauing of psychological effects despite rising plasma concentrations suggests the development of acute tolerance.

Published
October 28, 2023
Journal
Journal of Psychopharmacology
Authors
Luan, L. X., Eckernäs, E., Ashton, M., Rosas, F. E., Uthaug, M. V., Bartha, A., Jagger, S., Gascon-Perai, K., Gomes, L., Nutt, D. J., Erritzøe, D., Carhart-Harris, R. L., Timmermann, C.
Paywallindividual

Safety, tolerability, pharmacokinetics, and subjective effects of 50, 75, and 100 µg LSD in healthy participants within a novel intervention paradigm: A proof-of-concept study

This trial (n=32) assessed the safety, tolerability, pharmacokinetics, and subjective effects of 50, 75, and 100 µg LSD in healthy adults within a novel intervention paradigm. Participants received 50 (n = 3), 75 (n = 7), 100 (n = 3) LSD, 50 µg followed by 75 µg LSD (n = 9) 1 week apart, or placebo followed by a 75 µg LSD (n = 10) 1 week apart. No serious adverse events were reported, This data indicates that LSD is safe and well-tolerated with mild adverse events reported.

Published
March 7, 2022
Journal
Journal of Psychopharmacology
Authors
Family, N., Hendricks, P. S., Williams, L. T. J., Luke, D., Krediet, E., Raz, S., Malliet, E. L.
Paywallindividual

Effects of the psychedelic amphetamine MDA (3, 4-methylenedioxyamphetamine) in healthy volunteers

This double-blind, placebo-controlled study (n=12) investigated the effects of MDMA elder cousin, MDA. It found the duration to be longer (8 vs 6 hours), and with various characteristics more similar to classical psychedelics.

Published
April 9, 2019
Journal
Journal of Psychoactive Drugs
Authors
Baggott, M. J., Garrison, K. J., Coyle, J. R., Galloway, G. P., Barnes, A. J., Huestis, M. A., Mendelson, J. E.

Clinical Trials

5 trials
CompletedPhase I

A Study Assessing Brain Activity, Safety, Tolerability, and Pharmacokinetics Following Multiple Doses of MLS101 (Psilocybin) in Healthy Volunteers

This Phase I randomised, single-blind trial (n=20) will study the effects of multiple low doses of psilocybin (MLS101) on brain activity, safety, tolerability, and pharmacokinetics in healthy adult volunteers.

Started
July 1, 2025
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
NCT07050368
CompletedPhase I

KF2024#1-trial: Esketamine Interaction Study

This open-label, Phase I trial (n=12) will investigate the effects of different methods of esketamine administration (28 mg nasal spray vs. 28 mg oral solution) with and without CYP3A4 inhibitors (grapefruit juice or cobicistat) on drug absorption and metabolism.

Started
December 9, 2024
Type
interventional
Blinding
none
Randomized
Yes
Registry ID
NCT06726382
TerminatedPhase I

Dose-finding PKPD Trial for RE02 in Healthy Subjects

This double-blind, randomized, dose-response trial (n=15) aims to assess the pharmacokinetic and pharmacodynamic profiles of RE02, a psychedelic drug, in healthy subjects.

Started
November 20, 2023
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT05979727
CompletedPhase I

A Phase I Randomized, Placebo Controlled, Double-Blind, Single-Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of PCN-101 (Arketamine) and a Relative Safety Comparison of PCN-101 and Esketamine in Healthy Volunteers

Phase I, randomized, double-blind, placebo-controlled study in healthy volunteers assessing single ascending IV doses of PCN-101 (arketamine) and a crossover relative safety comparison with esketamine (15 mg IV).

Started
February 25, 2020
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
ACTRN12620000226909
CompletedPhase III

The Role of mTOR (Mammalian Target of Rapamycin) Signaling Pathway in the Antidepressive Effect of Ketamine in Patients with Depressive Disorder

This single-blind, placebo-controlled crossover trial (n=30), sponsored by Prague Psychiatric Centre, investigated whether mTOR activation differentiates ketamine responders from non-responders in patients with major depression.

Started
April 25, 2013
Type
interventional
Blinding
single
Randomized
No
Registry ID
2013-000952-17

Explore further

Search all Placebo papers Search all Medicinal Chemistry & Drug Development trials Full Placebo profile Full Medicinal Chemistry & Drug Development profile