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Home/Research/Placebo/Set & Setting

Placebo for Set & Setting

3 papers and 22 clinical trials exploring placebo as a treatment for set & setting.

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
IndicationApproximately 264 million individuals worldwide suffer from depression, with many seeking innovative treatment options such as psychedelic-assisted therapy.

Set & Setting

The concept of 'set and setting' is critical in psychedelic research, influencing therapeutic outcomes in clinical environments. Creating optimal conditions is essential for maximising the efficacy and safety of psychedelic-assisted therapies, particularly in the context of mental health disorders.

Full Set & Setting profile

Academic Research

3 papers
Open Accessindividual

Effects of external stimulation on psychedelic state neurodynamics

This further analysis of data from a single-blind, placebo-controlled study (n=20) on the effects of LSD (75µg) finds that the context (eyes closed/open, silence/music/video) modulates the level of brain entropy. The study finds that eyes-closed elicited the biggest response, and that video (external stimuli) disrupts the correlation between brain entropy and subjective ratings of the experience.

Published
January 12, 2024
Journal
ACS Chemical Neuroscience
Authors
Mediano, P. A. M., Rosas, F. E., Timmermann, C., Roseman, L., Nutt, D. J., Feilding, A., Kaelen, M., Kringelbach, M. L., Barrett, A. B., Seth, A. K., Muthukumaraswamy, S., Bor, D., Carhart-Harris, R. L.
Open Accessindividual

Isness: Using Multi-Person VR to Design Peak Mystical Type Experiences Comparable to Psychedelics

This study (n=57) assessed the experiences of people undergoing a Virtual Reality (VR) journey using the Mystical Experience Questionnaire (MEQ30). 'Isness' is a VR experience developed using concepts, methods and analysis strategies from psychedelic research. It was found that Isness participants reported Mystical Type Experiences comparable to those reported in double-blind clinical studies after high doses of psilocybin and LSD.

Published
April 23, 2020
Journal
Association for Computing Machinery
Authors
Glowacki, D. R., Wonnacott, M. D., Freire, R., Glowacki, B. R., Gale, E. M., Pike, J. E., De Haan, T., Chatziapostolou, M., Metatla, O.
Open Accessindividual

Tripping on nothing: placebo psychedelics and contextual factors

This placebo-only study (n=33) found that by creating a highly psychedelic-like setting (including actors), a majority of participants believed they felt some drug effects.

Published
March 7, 2020
Journal
Psychopharmacology
Authors
Olson, J. A., Suissa-Rocheleau, L., Lifshitz, M., Veissière, S. P. L., Raz, A.

Clinical Trials

22 trials
RecruitingPhase I

Drug Effects on Mood and Behavior – Expectancy (MESA-X)

Early Phase I, randomised, placebo-controlled single-session study (n=48) testing a low (13 µg) dose of LSD versus placebo under known versus uncertain drug-identity instructions (balanced placebo design).

Started
June 26, 2025
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT07061886
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 NA

Antidepressant Response of DMT Masked With Propofol (DMT4D)

This randomised, placebo-controlled, quadruple-masked trial (n=112) will investigate whether the antidepressant effects of DMT (2 mg/min over 20 minutes; total ~40 mg) in patients with MDD depend on the subjective psychedelic experience by comparing DMT vs placebo under propofol sedation or no sedation.

Started
April 1, 2025
Type
interventional
Blinding
quadruple
Randomized
Yes
Registry ID
NCT06927076
RecruitingPhase I

Direct Comparison of Altered States of Consciousness Induced by LSD, Psilocybin, and DMT in Healthy Participants (LPD)

This randomised, placebo-controlled, triple-blind Phase I crossover trial (n=24) will compare the acute and subacute effects of LSD (150µg), psilocybin (30mg), and DMT (up to 2 mg/min intravenous infusion) in healthy adults, with all sessions standardised using ketanserin (20 mg IV) to end the psychedelic experience after three hours.

Started
April 1, 2025
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06899334
RecruitingPhase I

The RECAP2 Study: Midazolam and Psilocybin

This triple-blind, randomised, placebo-controlled trial (n=60) will study the role of neuroplasticity in the behavioural effects of psilocybin in individuals with mild declines in emotional wellbeing. Participants will receive one of four medication combinations (25 mg or 1 mg psilocybin with IV midazolam or IV saline).

Started
February 1, 2025
Type
interventional
Blinding
triple
Randomized
Yes
Registry ID
NCT06692192
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

Explore further

Search all Placebo papers Search all Set & Setting trials Full Placebo profile Full Set & Setting profile