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Home/Research/MDMA/Set & Setting

MDMA for Set & Setting

22 papers and 9 clinical trials exploring mdma as a treatment for set & setting.

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 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

22 papers
Open Accessmeta

Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis

This systematic review and meta-analysis (2024) examined the side effects of MDMA-assisted psychotherapy (MDMA-AP) across Phase II and III studies. Thirteen studies were included, with most showing an increase in side effects during medication sessions and the following week compared to control conditions. Despite these findings, the overall certainty of evidence was rated as very low to moderate, and the quality of side effects reporting was generally poor, suggesting further research is needed to fully understand the safety profile of MDMA-AP.

Published
April 23, 2024
Journal
Neuropsychopharmacology
Authors
Colcott, J., Guerin, A. A., Carter, O., Meikle, S., Bedi, G.
Open Accessindividual

Subjective long-term emotional and social effects of recreational MDMA use: the role of setting and intentions

Analysing self-reports from 766 predominantly Western recreational MDMA users with K-medoids clustering, the authors identified three consumption-setting types (party with friends, private home, mixed) and three intention types (euphoria/energy, self‑insight, mixed). Users with self‑insight or mixed intentions reported substantially greater long-term socio‑emotional benefits than those seeking euphoria/energy, while consumption setting was unrelated to these outcomes.

Published
February 10, 2024
Journal
Scientific Reports
Authors
Elmer, T., Vannoy, T. K., Studerus, E., Lyubomirsky, S.
Paywallindividual

Set and setting predict psychopathology, wellbeing and meaningfulness of psychedelic experiences: a correlational study

This survey (n=1022) investigated the correlation between set and setting variables in psychedelic therapy with psychopathology, well-being, and personality. Findings suggest that growth motivations, natural settings, and the presence of significant others predict positive outcomes. In contrast, problematic motivations are associated with greater psychopathology and lower well-being.

Published
December 20, 2023
Journal
Expert Review of Clinical Pharmacology
Authors
Borkel, L. F., Rojas-Hernández, J., Henríquez-Hernández, L. A., Del Pino, A. S., Quintana-Hernández, D. J.
Open Accessindividual

Nature-themed video intervention may improve cardiovascular safety of psilocybin-assisted therapy for alcohol use disorder

In a pilot randomised controlled trial of 20 participants with alcohol use disorder, viewing a nature-themed "Visual Healing" video during preparation and the ascent/descent phases of 25 mg psilocybin sessions was feasible, safe and well tolerated. Compared with standard procedures (eyeshades and music), Visual Healing significantly attenuated peak post‑psilocybin blood pressure increases while producing similar psychedelic effects and reductions in alcohol use.

Published
September 18, 2023
Journal
Frontiers in Psychiatry
Authors
Heinzerling, K. G., Sergi, K., Linton, M., Rich, R., Youssef, B., Bentancourt, I., Bramen, J., Siddarth, P., Schwartzberg, L., Kelly, D. F., Ahmed, S.
Open Accessmeta

Dosing and Therapeutic Conduct in Administration Sessions in Substance-Assisted Psychotherapy: A Systematized Review

This systematised review of 82 sources synthesised published guidance on substances, dosages, session structure, music and in-session therapeutic conduct for administration sessions with serotonergic psychedelics and entactogens. It concludes that evidence is largely anecdotal and non-rigorous, leaving essential components of therapeutic interventions tentative and in need of systematic empirical investigation.

Published
May 3, 2023
Journal
Journal of Humanistic Psychology
Authors
Thal, S. B., Wieberneit, M., Sharbanee, J. M., Skeffington, P. M., Bruno, R., Wenge, T., Bright, S. J.
Open Accessmeta

Hofmann vs. Paracelsus: Do Psychedelics Defy the Basics of Toxicology?-A Systematic Review of the Main Ergolamines, Simple Tryptamines, and Phenylethylamines

A PRISMA-guided systematic review of ergolamines, simple tryptamines and phenylethylamines (33 studies from 3,032 records) finds that classic psychedelics are active at very low doses, non‑addictive and generally only harmful at extremely high doses, with no established lethal dose for LSD or psilocybin. MDMA appears to carry the greatest apparent toxicity—likely confounded by recreational misuse—and the authors emphasise that risk is strongly modulated by set and setting.

Published
February 3, 2023
Journal
Toxics
Authors
Henríquez-Hernández, L. A., Rojas-Hernández, J., Quintana-Hernández, D. J., Borkel, L. F.

Clinical Trials

9 trials
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
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
RecruitingPhase II/III

A study of the psychological, cognitive and physiological effects of Psychedelic Medicines (ASSESS)

This non-randomized trial (n=100) investigates the psychological, cognitive, and physiological effects of a single session of psychedelic drug exposure with either psilocybin or MDMA in a group setting.

Started
September 26, 2023
Type
interventional
Blinding
none
Randomized
No
Registry ID
ACTRN12622001535763
Not yet recruitingPhase II

Developing Optimal Psychedelic Assisted Psychotherapy for Obsessive-Compulsive Disorder

This interventional randomised, blinded, parallel Phase II trial (n=40) compares MDMA-assisted psychotherapy (3 × 100 mg oral sessions) to psilocybin-assisted psychotherapy (3 × 25 mg oral sessions) for treatment-resistant OCD, with preparatory and integration therapy.

Started
August 1, 2023
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
ACTRN12622001525774
Enrolling by invitationPhase NA

The Role of Personal Experience for the Therapeutic Attitude in the Context of Substance-assisted Therapy Training (TherPsySE)

Single-group interventional study (n=48) assessing effects of personal psychedelic experience (MDMA, LSD, psilocybin) on therapists' therapeutic attitude and related capacities during SÄPT training.

Started
December 1, 2022
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT05570708
RecruitingPhase I/II

An Open-Label Feasibility Study to Assess the Safety and Effect of Manualised MDMA-Assisted Psychotherapy for the Treatment of Severe Posttraumatic Stress Disorder among Four Australians

Open-label feasibility single-group study (n=4) of MAPS manualised MDMA-assisted psychotherapy for treatment-refractory PTSD with three MDMA-assisted sessions (initial 80 mg; supplemental half-dose at 1.5–2 h; sessions 2–3 may use 80–120 mg).

Started
May 19, 2022
Type
interventional
Blinding
none
Randomized
No
Registry ID
ACTRN12621001078842

Explore further

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