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Home/Research/MDMA/Implementation & Service Delivery

MDMA for Implementation & Service Delivery

4 papers and 4 clinical trials exploring mdma as a treatment for implementation & service delivery.

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 people worldwide suffer from depression, while substance use disorders affect around 35 million globally.

Implementation & Service Delivery

This report explores the implementation and service delivery of psychedelic therapies, focusing on compounds such as psilocybin, MDMA, and LSD in various therapeutic contexts. Recent legislative efforts and clinical trials indicate a growing acknowledgement of the therapeutic potential of psychedelics, particularly in addressing mental health conditions and substance use disorders.

Full Implementation & Service Delivery profile

Academic Research

4 papers
Open Accessmeta

Developing an Ethics and Policy Framework for Psychedelic Clinical Care: A Consensus Statement

A multidisciplinary group produced a consensus ethics and policy framework for integrating government‑approved psychedelic medicines into clinical care, articulating 20 consensus points across five core ethical domains. The statement assigns responsible actors for implementation and identifies areas for further research and policy deliberation to promote equitable, safe adoption in mainstream medicine.

Published
June 4, 2024
Journal
JAMA Network Open
Authors
McGuire, A. L., Cohen, I. G., Sisti, D., Baggott, M., Celidwen, Y., Devenot, N., Gracias, S., Grob, C. S., Harvey, I., Kious, B., Marks, M., Mithoefer, M. C., Nielson, E. M., Öngür, D., Pallas, A., Peterson, A., Schenberg, E. E., Summergrad, P., Waters, B., Williams, M. T., Yaden, D. B.
Open Accessindividual

Group psychedelic therapy: empirical estimates of cost-savings and improved access

Analysing 2023 data from MDMA-assisted PTSD and psilocybin-assisted MDD trials, the authors show that group therapy markedly reduces clinician time and costs while expanding potential patient access. Group protocols cut clinician costs by 50.9% for MDMA‑PTSD (≈$3,467 per patient) and 34.7% for psilocybin‑MDD (≈$981), potentially freeing 6,711 and 1,159 FTE clinicians respectively and saving up to $10.3 billion and $2.0 billion in the US over 10 years (3% annual discount).

Published
December 6, 2023
Journal
Frontiers in Psychiatry
Authors
Marseille, E., Stauffer, C., Agrawal, M., Thambi, P., Roddy, K., Mithoefer, M. C., Bertozzi, S. M., Kahn, J. G.
Paywallindividual

The Canadian Psychedelic Survey: Characteristics, Patterns of Use, and Access in a Large Sample of People Who Use Psychedelic Drugs

This survey (n=2045) of Canadian psychedelic users finds psilocybin, MDMA and LSD are the most commonly used. It also reports positive (82%) life changes and challenging experiences (52%). Motivations for use include fun, self-exploration, general mental well-being, and personal growth.

Published
June 1, 2023
Journal
Psychedelic Medicine
Authors
Lake, S., Lucas, P.
Paywallindividual

Acute and enduring effects of naturalistic psychedelic use among Indigenous peoples in Canada and the United States

This survey study (n=66) explored the effects of naturalistic psychedelic use on recalled psychological distress and trauma symptoms among Indigenous peoples living in the United States and Canada who had experienced racial trauma. The most commonly used psychedelics were psilocybin, MDMA and LSD. Participants recalled experiencing fewer symptoms of depression, anxiety, stress, trauma, symptoms of discrimination, and alcohol use in the 30 days after (vs. before) the psychedelic experience

Published
November 1, 2022
Journal
Canadian Psychology
Authors
de la Salle, S., Gran-Ruaz, S., Davis, A. K., Davis, D., Williams, M. T.

Clinical Trials

4 trials
RecruitingPhase II

MDMA-assisted Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder

This randomized, interventional trial (n=30) will compare MDMA-assisted Cognitive Processing Therapy (three MDMA sessions plus preparatory and integration therapy) versus standard Cognitive Processing Therapy for Veterans with severe PTSD.

Started
September 1, 2023
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
NCT05837845
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
WithdrawnPhase I

Psychological Effects of Methylenedioxymethamphetamine (MDMA) When Administered to Healthy Volunteers (MT-2)

Phase 1, open-label, single-group study (n=150) assessing psychological effects and safety of a single 120 mg MDMA dose (optional 60 mg supplemental) paired with preparatory and integrative therapy sessions in healthy volunteers and therapists in training.

Started
January 7, 2021
Type
interventional
Blinding
none
Randomized
No
Registry ID
NCT04073433
RecruitingPhase NA

Evaluating the atittudes of Australian psychologists, psychiatrists and mental health researchers towards 3,4-Methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for the treatment of PTSD: A double-blind, randomised controlled trial

This double-blind, randomised controlled trial (n=200) aims to evaluate the attitudes of Australian psychologists, psychiatrists, and mental health researchers towards MDMA-assisted psychotherapy for the treatment of PTSD.

Started
February 11, 2020
Type
interventional
Blinding
single
Randomized
Yes
Registry ID
ACTRN12620001068954

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