Journal of psychopharmacology (Oxford, England)
June 10, 2025
Torsten Passie, Anja Loizaga-Velder, Alicia Danforth et al.
4 citations
The authors offer a model for curriculum for education and training in substance-assisted psychotherapy (SAP), that is, psychedelic, psycholytic, and entactogen/MDMA (3,4-methylenedioxymethamphetamine)-assisted psychotherapy, addressing both the detailed contents of training and the question of experiential training. All authors of this model have an abiding interest and extensive experience in...
Psychopharmacology (Berl)
November 1, 2024
Lisa Jerome, Allison A. Feduccia, Julie B. Wang et al.
10 citations
Retraction Note: Long-term follow-up outcomes of MDMA-assisted psychotherapy for treatment of PTSD: a longitudinal pooled analysis of six phase 2 trials.
Psychopharmacology (Berl)
November 1, 2024
Michael C Mithoefer, Allison A. Feduccia, Lisa Jerome et al.
9 citations
Retraction Note: MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials.
Psychopharmacology (Berl)
November 1, 2024
Allison A. Feduccia, Lisa Jerome, Michael C Mithoefer et al.
6 citations
Retraction Note: Discontinuation of medications classified as reuptake inhibitors affects treatment response of MDMA-assisted psychotherapy.
Nat Med
November 1, 2024
Jennifer Mitchell, Marcela Ot’alora G., Bessel Van der Kolk et al.
4 citations
In the version of the article initially published, some members of the MAPP2 Study Collaborator Group were listed only in the Supplementary Information. Charlotte Harrison, Berra Yazar-Klosinski, Wael Garas, Darrick May, Cole Marta, Susan Walker, Elizabeth Nielson, Gregory Wells, Randall Brown, Revital Amiaz, Yair Wallach, Ray Worthy, Alia Lilienstein and Amy Emerson have now been added to the...
JAMA Network Open
June 3, 2024
Amy L. Mcguire, I Glenn Cohen, Dominic Sisti et al.
41 citations
As government agencies around the globe contemplate approval of the first psychedelic medicines, many questions remain about their ethical integration into mainstream medical practice. To identify key ethics and policy issues related to the eventual integration of psychedelic therapies into clinical practice. From June 9 to 12, 2023, 27 individuals representing the perspectives of clinicians,...
PLoS One
January 10, 2024
Rachel Yehuda, Leah Bedrosian, Charlotte Harrison et al.
52 citations
Introduction There is a resurgence of interest in the therapeutic potential of psychedelic substances such as 3,4-methylenedioxymethamphetamine (MDMA). Primary findings from our randomized, double-blind, placebo-controlled, multi-site Phase 3 clinical trial of participants with severe PTSD (NCT03537014) showed that MDMA-assisted therapy induced significant attenuation in the...
European Journal of Psychotraumatology
2024
Richard J. Zeifman, Hannes Kettner, Stephen Ross et al.
34 citations
Background: MDMA-assisted psychotherapy (MDMA-AP) is a combined psychotherapeutic and pharmacologic intervention that shows promise in the treatment of posttraumatic stress disorder (PTSD). Although therapeutic alliance has been established as a key predictor across psychotherapies and is emphasised within MDMA-AP treatment manuals, research has not yet examined the relationship between...
Am J Psychiatry
2024
Michael Alpert, Kelley C. O’donnell, Casey Paleos et al.
22 citations
Psychotherapy in Psychedelic Treatment: Safe, Evidence-Based, and Necessary.
Frontiers in Psychology
2024
Kelley C O'Donnell, Lauren Okano, Michael Alpert et al.
Results from multiple recent studies support further evaluation of 3,4-methylenedioxymethamphetamine (MDMA) in conjunction with psychotherapy (i.e., MDMA-Assisted Therapy) in the treatment of post-traumatic stress disorder (PTSD). In two Phase 3 trials, MDMA-Assisted Therapy comprised a short-term, intensive psychotherapy that included three sessions directly facilitated by MDMA (referred to as...
Frontiers in Psychiatry
December 6, 2023
Elliot Marseille, Manish Agrawal, Paul Thambi et al.
40 citations
Objective To compare group and individual psychedelic-assisted therapy in terms of clinician time, costs and patient access. Methods Using 2023 data from two group therapy trial sites, one using 3,4-Methylenedioxymethamphetamine (MDMA) to treat posttraumatic stress disorder (PTSD), and one using psilocybin to treat major depressive disorder (MDD), we compared overall variable costs, clinician...
Nature Medicine
October 1, 2023
Jennifer Mitchell, Marcela Ot’alora G., Bessel Van der Kolk et al.
400 citations
This multi-site, randomized, double-blind, confirmatory phase 3 study evaluated the efficacy and safety of 3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) versus placebo with identical therapy in participants with moderate to severe post-traumatic stress disorder (PTSD). Changes in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total severity score (primary endpoint) and...
Focus (American Psychiatric Publishing)
July 1, 2023
Jennifer Mitchell, Michael P. Bogenschutz, Alia Lilienstein et al.
97 citations
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...
Focus (American Psychiatric Publishing)
July 1, 2023
Allison A. Feduccia, Lisa Jerome, Berra Yazar-Klosinski et al.
24 citations
Unsuccessfully treated posttraumatic stress disorder (PTSD) is a serious and life-threatening disorder. Two medications, paroxetine hydrochloride and sertraline hydrochloride, are approved treatments for PTSD by the Food and Drug Administration (FDA). Analyses of pharmacotherapies for PTSD found only small to moderate effects when compared with placebo. The Multidisciplinary Association for...
Psychedelics as Psychiatric Medications
March 1, 2023
Michael C Mithoefer, David E. Presti
Abstract MDMA (3,4-methylenedioxymethamphetamine) was originally synthesized and patented by the Merck chemical company in 1914. It was not explored for human use until the 1970–80s when there were published reports that it could be a useful catalyst to psychotherapy, in part because it often produced reduced anxiety and increased emotional openness. In 1985, in response to media attention to...
medRxiv Preprint Server
January 3, 2023
Bessel Van der Kolk, Julie B. Wang, Rachel Yehuda et al.
2 citations
preprint
In recent years there has been a resurgence of interest in the therapeutic potential of psychedelic substances such as 3,4-methylenedioxymethamphetamine (MDMA). This renaissance of psychedelic studies opens the door for a new paradigm in psychiatric medicine: drug-facilitated psychotherapy. In this study we report the findings of a randomized, double-blind, placebo-controlled, multi-site Phase...
Journal of Psychiatric Research
May 1, 2022
Timothy D Brewerton, Julie B. Wang, Adele Lafrance et al.
81 citations
Eating disorders (EDs) and posttraumatic stress disorder (PTSD) are highly comorbid, yet there are no proven integrative treatment modalities for ED-PTSD. In clinical trials, MDMA-assisted therapy (MDMA-AT) has shown marked success in the treatment of PTSD and may be promising for ED-PTSD. Ninety individuals with severe PTSD received treatment in a double-blind, placebo-controlled pivotal trial...
Frontiers in Psychiatry
2022
S Parker Singleton, Julie B. Wang, Michael C Mithoefer et al.
36 citations
3,4-methylenedioxymethamphetamine-assisted therapy (MDMA-AT) for post-traumatic stress disorder (PTSD) has demonstrated promise in multiple clinical trials. MDMA is hypothesized to facilitate the therapeutic process, in part, by decreasing fear response during fear memory processing while increasing extinction learning. The acute administration of MDMA in healthy controls modifies recruitment...
Journal of Traumatic Stress
August 1, 2021
Linnae Ponté, Lisa Jerome, Scott Hamilton et al.
42 citations
Expression of concern
Sleep disturbances (SDs) are among the most distressing and commonly reported symptoms in posttraumatic stress disorder (PTSD). Despite increased attention on sleep in clinical PTSD research, SDs remain difficult to treat. In Phase 2 trials, 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy has been shown to greatly improve PTSD symptoms. We hypothesized that MDMA-assisted...
Journal of Humanistic Psychology
June 23, 2021
Julie B. Wang, Jessica Lin, Leah Bedrosian et al.
22 citations
Background: Posttraumatic stress disorder (PTSD) is a debilitating mental health condition associated with serious adverse health outcomes and functional impairment. Previous MDMA–assisted therapy (MDMA-AT) studies have shown promising results in single site studies. Two open-label studies tested this modality in multisite clinical trials to assess the feasibility of scaling this manualized...
Nature Medicine
June 1, 2021
Jennifer Mitchell, Michael P. Bogenschutz, Alia Lilienstein et al.
965 citations
Post-traumatic stress disorder (PTSD) presents a major public health problem for which currently available treatments are modestly effective. We report the findings of a randomized, double-blind, placebo-controlled, multi-site phase 3 clinical trial (NCT03537014) to test the efficacy and safety of 3,4-methylenedioxymethamphetamine (MDMA)-assisted therapy for the treatment of patients with...
Revista brasileira de psiquiatria (Sao Paulo, Brazil : 1999)
2021
Alvaro V Jardim, Dora V Jardim, Bruno Rasmussen Chaves et al.
54 citations
To conduct Brazil's first clinical trial employing 3,4-methylenedioxymethamphetamine (MDMA)-assisted psychotherapy for post-traumatic stress disorder (PTSD), given its high prevalence resulting from epidemic violence. Of 60 volunteers, four matched the inclusion & exclusion criteria. Three patients with PTSD secondary to sexual abuse (diagnosed by the Structured Clinical Interview for DSM-IV...
Frontiers in Psychiatry
2021
Anne C Wagner, Rachel E Liebman, Ann T Mithoefer et al.
40 citations
Healing from trauma occurs in a relational context, and the impacts of traumatic experiences that result in post-traumatic stress disorder (PTSD) go beyond the diagnosis itself. To fully understand a treatment for PTSD, understanding its impact on interpersonal, relational, and growth outcomes yields a more fulsome picture of the effects of the treatment. The current paper examines these...
Medical Hypotheses
2021
Timothy D Brewerton, Adele Lafrance, Michael C Mithoefer
28 citations
Despite advances in the field, eating disorders (EDs) remain very challenging disorders to treat, especially when comorbid with posttraumatic stress disorder (PTSD). N-methyl-3,4-methylenedioxyamphetamine (MDMA)-assisted psychotherapy for treatment refractory PTSD shows great promise, with two-thirds of participants achieving full remission at 1 year or more at follow-up. PTSD is a common...
European Journal of Psychotraumatology
December 7, 2020
Candice M Monson, Anne C Wagner, Ann T Mithoefer et al.
90 citations
Cognitive-behavioural conjoint therapy (CBCT) for PTSD has been shown to improve PTSD, relationship adjustment, and the health and well-being of partners. MDMA (3,4-methylenedioxymethamphetamine) has been used to facilitate an individual therapy for PTSD. This study was an initial test of the safety, tolerability, and efficacy of MDMA-facilitated CBCT. Six couples with varying levels of...