J Palliat Med
April 13, 2021
Yvan Beaussant, James Tulsky, Benjamin Guérin et al.
34 citations
Researchers from palliative care, psychosocial oncology, spiritual care, oncology, and psychedelic-assisted therapies identified seven key opportunities for advancing research on psychedelic-assisted therapy for people with serious illness. Four opportunities relate to science and design: clarifying which conditions the therapy is indicated for, developing and refining therapeutic protocols, investigating how set and setting affect outcomes, and understanding mechanisms of action. Three opportunities concern institutional and societal drivers: education and certification for therapists, regulations and funding, and diversity and inclusion. Participants also noted epistemological limitations of the medical model for understanding psychedelics' therapeutic value.
Focus (American Psychiatric Publishing)
July 1, 2023
Allison A Feduccia, Lisa Jerome, Berra Yazar-Klosinski et al.
24 citations
Two FDA-approved medications for PTSD, paroxetine and sertraline, show only small to moderate effects over placebo. Pooled analyses of Phase 2 studies indicate that MDMA-assisted psychotherapy—combining the drug with three monthly 8-hour therapy sessions plus preparatory and integrative sessions—produces a large effect size and lower dropout rates than the approved medications. The treatment also carries minimal risk of diversion, overdose, or withdrawal because MDMA is administered under direct observation. This review describes the data that earned MDMA-assisted psychotherapy Breakthrough Therapy Designation from the FDA, which has accelerated Phase 3 trials toward a planned 2021 submission for FDA approval.
Journal of Humanistic Psychology
June 23, 2021
Julie B. Wang, Jessica Lin, Leah Bedrosian et al.
22 citations
MDMA-assisted therapy (MDMA-AT) can be scaled across multiple clinic sites while maintaining high treatment fidelity. In an open-label study across 14 North American sites, cotherapist dyads were trained in a manualized protocol and administered three experimental sessions to participants with severe PTSD. Adherence to the therapy protocol was high across both dyads and sites. PTSD symptom severity, measured by the CAPS-5, decreased substantially after three sessions at 18 weeks. MDMA was well tolerated. These results indicate that the benefits of MDMA-AT for PTSD can be achieved in a multi-site, real-world clinical setting.
Journal of Psychopharmacology
August 16, 2022
Brian S. Barnett, Kathleen M Ziegler, Rick Doblin et al.
15 citations
An analysis of nationally representative survey data from 2015-2019 found no association between lifetime use of psychedelics and lifetime diagnosis of any cancer or hematologic cancer. Sub-analyses of specific classes of psychedelics—lysergamides, phenethylamines, and tryptamines—also showed no link to cancer diagnoses. These findings contrast with earlier laboratory studies and case reports from the 1960s and 1970s that raised concerns about psychedelics' carcinogenic potential. Limitations include lack of data on dosage, number of lifetime exposures, and timing of use relative to cancer diagnosis.
Psychopharmacology (Berl)
November 1, 2024
Lisa Jerome, Allison A. Feduccia, Julie B. Wang et al.
10 citations
This is a retraction note for a previously published article on the long-term outcomes of MDMA-assisted psychotherapy for PTSD. The original article reported a longitudinal pooled analysis of six phase 2 trials, but it has been retracted. The retraction does not provide any findings or data about the treatment's efficacy or long-term effects.
Psychopharmacology (Berl)
November 1, 2024
Michael C. Mithoefer, Allison A. Feduccia, Lisa Jerome et al.
9 citations
This is a retraction note for a previously published article about MDMA-assisted psychotherapy for PTSD. The original article described the design and rationale for phase 3 trials, which were based on a pooled analysis of six phase 2 randomized controlled trials. The retraction indicates that the original article should not be relied upon, but the note itself does not provide any findings or data about the treatment's effectiveness.
medRxiv Preprint Server
May 25, 2022
S. Parker Singleton, Julie B. Wang, Michael Mithoefer et al.
9 citations
preprint
In nine veterans and first-responders with chronic PTSD, MDMA-assisted therapy did not significantly increase amygdala-hippocampus resting-state functional connectivity as hypothesized, only showing a trend. After treatment, activation in the cuneus decreased when recalling traumatic versus neutral memories. The amount of PTSD recovery correlated with changes in four functional connections during autobiographical memory recall: left amygdala with left and right posterior cingulate cortex and left insula, and left isthmus cingulate with left posterior hippocampus. These findings suggest that MDMA-AT may alter functional connectivity in brain regions involved in memory and fear processing, but more research is needed to determine if these effects are specific to MDMA-AT compared to other PTSD treatments.
Nat Med
November 1, 2024
Jennifer M. Mitchell, Marcela Ot’alora G, Bessel Van der Kolk et al.
4 citations
No Summary
Figshare
January 1, 2020
Brian S. Barnett, Yvan Beaussant, Franklin King et al.
3 citations
Psychiatrists attending national professional conferences vary in their knowledge and opinions about psychedelics and psychedelic-assisted psychotherapies, as measured by a survey instrument. The instrument gauges both factual understanding and personal attitudes, revealing gaps in knowledge and a range of opinions that may influence clinical practice and future adoption of these therapies.
medRxiv Preprint Server
January 3, 2023
Bessel A. van der Kolk, Julie B. Wang, Rachel Yehuda et al.
2 citations
preprint
A Phase 3 clinical trial tested MDMA-assisted therapy (MDMA-AT) against placebo with therapy for severe PTSD. 85% of participants reported early childhood trauma, linked to deficits in emotional coping. MDMA-AT significantly improved alexithymia, self-compassion, and altered self-capacities compared to therapy alone. These changes address transdiagnostic mental processes that often hinder treatment response.
Archives of Clinical Neuropsychology
August 31, 2016
Michael Wagner, Michael C. Mithoefer, Ann T. Mithoefer et al.
1 citation
In a Phase II clinical trial of MDMA-assisted psychotherapy for chronic, treatment-resistant PTSD, increases in Openness and decreases in Neuroticism personality traits were linked to greater symptom reduction, regardless of treatment condition. Participants receiving MDMA showed the largest gains in Openness, which predicted lower PTSD severity. The authors propose that MDMA, combined with psychotherapy, may facilitate a reorganization of mental experience through altered brain pathways, rather than through psychological learning alone.