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Home/Research/Placebo/Safety & Risk Management

Placebo for Safety & Risk Management

15 papers and 34 clinical trials exploring placebo as a treatment for safety & risk management.

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
IndicationMental health disorders affect over 900 million people worldwide, with conditions like PTSD and depression being among the most prevalent.

Safety & Risk Management

Safety and risk management in psychedelic therapy remains a critical area of research, necessitating vigilant assessment of potential adverse effects as clinical usage expands. Current efforts focus on ensuring that therapeutic practices minimise harm while maximising efficacy for a range of conditions.

Full Safety & Risk Management profile

Academic Research

15 papers
Open Accessindividual

Efficacy and Safety of Psilocybin in Treatment-Resistant Major Depression: The EPISODE Randomized Clinical Trial

In this triple‑blind, active placebo‑controlled randomised trial (n=144) of adults with treatment‑resistant depression, two 25 mg doses of psilocybin plus adjunct psychotherapy produced clinically meaningful reductions in depressive symptoms on exploratory secondary measures but did not significantly improve the pre‑second‑dose HAMD17 response rate versus nicotinamide.

Published
March 18, 2026
Journal
JAMA Psychiatry
Authors
Mertens, L. J., Koslowski, M., Betzler, F., Brand, M., Evens, R., Kärtner, L., Jungaberle, A., Jungaberle, H., Majić, T., Schmitz, C. N., Ströhle, A., Scharf, D., Spangemacher, M., Wolff, M., Assadi, Z., Bahri, S., Becher, L., Färber, L. V., Kirchen, N., Kulakova, E., Kunz, L., Meijer, A., Rohrmoser, B., Wellek, S., Berger, M. M., Gründer, G.
Paywallindividual

Single Treatment With MM120 (Lysergide) in Generalized Anxiety Disorder: A Randomized Clinical Trial

In a multicentre phase 2b randomised placebo‑controlled trial of 198 adults with moderate to severe GAD, a single dose of MM120 (lysergide D‑tartrate) produced a dose‑dependent reduction in HAM‑A scores at 4 weeks, with 100 µg and 200 µg showing significant improvements versus placebo (least‑squares mean differences −5.0 and −6.0 points, respectively). Adverse events were dose‑related—most commonly visual perceptual changes and nausea—supporting the efficacy and informing dose selection for phase 3 trials.

Published
October 21, 2025
Journal
JAMA
Authors
Robison, R., Barrow, R., Conant, C., Foster, E., Freedman, J. M., Jacobsen, P. L., Karas, S. M., Karlin, D. R., Solomon, T. M., Wernli, M. H., Fava, M. F., Jemisen, J.
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.
Paywallindividual

Safety, tolerability and subjective effects of vaporized N,N-Dimethyltryptamine: A randomized double-blind clinical trial

This first RCT (n=25) of vaporised DMT (60mg) demonstrated that DMT significantly increased subjective experience measures while causing only transient, safe physiological changes and predominantly mild adverse events. This suggests that inhaled DMT is safe, well-tolerated, and effective at inducing profound altered states of consciousness. Significant correlations were observed between physiological responses and subjective experiences.

Published
June 17, 2025
Journal
European Neuropsychopharmacology
Authors
Wießner, I., Falchi-Carvalho, M., Laborde, S., Barros, H., Bolcont, R., Ruschi Silva, S., Pantrigo, E. J., Medina, M., Arichelle, F., Almeida, R., Aires, R., Nunes Ferreira, L. F., Dantas Correa, L., da Costa Bezerra, R. B., Thie, K., Silva-Costa, N., Araújo, D. B., de Araujo Costa Neto, L. A., Lima de Queiroz, M. V. J., Galvão-Coelho, N. L., Palhano-Fontes, F.
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

Safety and cognitive pharmacodynamics following dose escalations with 3-methylmethcathinone (3-MMC): a first in human, designer drug study

In a first‑in‑human, placebo‑controlled crossover study in 14 volunteers, escalating low–moderate doses (25–100 mg) of 3‑MMC produced dose‑dependent but clinically modest increases in heart rate and blood pressure, transient psychostimulant and mild psychotomimetic effects, and improved performance across processing speed, cognitive flexibility, attention, memory and psychomotor tasks without impairing impulse control. The authors conclude that these low–moderate doses were well tolerated and pharmacodynamically resemble amphetamine‑type stimulants, with potential health risks likely to arise only at high or excessive doses.

Published
December 24, 2024
Journal
Neuropsychopharmacology
Authors
Ramaekers, J. G., Reckweg, J., Mason, N. L., Kuypers, K. P. C., Toennes, S. W., Theunissen, E. L.

Clinical Trials

34 trials
CompletedPhase II

A Study to Assess the Use of Methylone in the Treatment of PTSD (IMPACT-1)

This Phase II, two-part, multicentre trial (n=64) will assess methylone as a treatment for adults with post-traumatic stress disorder (PTSD). It is designed to evaluate the drug’s safety, tolerability, and efficacy in participants aged 18–65 years in the UK, including people who have previously tried at least one PTSD treatment without sufficient benefit.

Type
interventional
Blinding
double
Randomized
Yes
Not yet recruitingPhase III

PAPAYA: Pharmacologically-Assisted Psychotherapy for social Anxiety in Young people with Autism

This randomised, blinded, Phase III trial (n=156) will investigate MDMA-assisted psychotherapy (weight-based dosing with supplemental doses) versus dexamfetamine-, lorazepam-, diphenhydramine-, or placebo-assisted psychotherapy for social anxiety in autistic young people.

Started
January 15, 2025
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
ACTRN12624001474549p
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
RecruitingPhase I

Safety for Home Administration of Microdose Psilocybin Use

This single-blind interventional trial (n=20) will investigate the safety of ascending doses of psilocybin for home administration.

Started
August 1, 2024
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
NCT06450210
Not yet recruitingPhase III

The Kite Trial: Examining the Effectiveness of Ketamine for Adults with Bipolar Depression

This randomised, double-blind, midazolam-controlled, multicentre trial (n=98) will investigate the efficacy and safety of low-dose subcutaneous ketamine in adults with bipolar depression.

Started
June 28, 2024
Type
interventional
Blinding
double
Randomized
Yes
Registry ID
ACTRN12624000789561
CompletedPhase NA

The Effect of Esketamine on Sleep Disturbance

Randomised, triple-blind, parallel-group trial (n=204) testing a single 0.2 mg/kg IV esketamine injection versus 5 ml 0.9% saline in females undergoing surgical abortion with sleep disturbance.

Started
May 3, 2024
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06388824

Explore further

Search all Placebo papers Search all Safety & Risk Management trials Full Placebo profile Full Safety & Risk Management profile