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A library search and analysis of extant literature reviews was conducted to identify publications containing original research findings with inter-group statistical comparisons from randomized, controlled trials of MDMA-AT. Seven articles were identified. One pilot study was excluded due to a lack of inter-group comparison. Study design, sponsor, recruitment methods, and participant demographics are similar across trials. However, the lack of suitable comparison condition, poor blinding, and rigid study design across trials make interpretation of results difficult. The role of the sponsoring organization behind all trials may further introduce bias into findings. Department of Veterans Affairs, n. DeAngelis, Adverse outcomes of social, occupational, medical, and behavioral dysfunction are more common among certain groups with high risk of exposure to trauma e. Pharmacologic management of PTSD is also common, with nearly 9 out of 10 military veterans with PTSD receiving a drug prescription for the alleviation of symptoms Alexander, For both psychotherapeutic and pharmacologic interventions, cases of full remission usually make up a minority of outcomes Alexander, ; Schottenbauer et al. Policy consequences of the movement are already evident, with a July reclassification of MDMA by the Australian Therapeutic Goods Administration for use by psychiatrists in the treatment of depression Nogrady, Other countries' regulatory bodies show signs of intending to follow suit in rescheduling MDMA and other compounds, including the UK and, most likely, the U. Indeed, the American Psychiatric Association APA released a position statement stressing the lack of sufficient evidence for the treatment's efficacy and urging caution Knopf, This critical review seeks to fill this gap and provide a summary of unanswered questions about this novel therapy. MDMA is also hypothesized to modulate memory function including reconsolidation, destabilization following recall, extinction, and generalization Raut et al. It has been shown to reduce stress-induced neuroinflammation, thereby attenuating fear learning Parekh et al. The drug's effects include a release of oxytocin, which, when combined with therapy, may strengthen therapeutic alliance and bolster approach toward feared memories Mithoefer, Jerome, et al. The psychotherapeutic component of the treatment centers on participants' phenomenological experience while under the influence of the empathogen compound Godes et al. The approach of MDMA-AT is largely inherited from methods described by Greer and Tolbert , a husband-and-wife team of psychiatric professionals who treated consenting patients with MDMA, often in the living room of their own home. Following the example of Greer and Tolbert, sessions of MDMA-AT are conducted by a male and female co-therapist team, occur in a living room-style environment, involve extensive therapist self-disclosure, and proceed with minimal direction from the therapists Mithoefer et al. The treatment modality additionally includes the use of music, physical touch, art supplies, and incorporation of significant others into therapy. Pinpointing mechanisms of action is therefore difficult. Though described as a manualized treatment Mitchell et al. Following screening, participants in MDMA-AT undergo two to three min preparatory sessions oriented toward familiarizing participants with the course of treatment, building rapport, and establishing expectations for drug sessions Mithoefer et al. Then, participants undergo an MDMA drug session, which lasts approximately eight hours. Commonly, meals, overnight accommodations, and a trained attendant are provided for participants following drug sessions. After each MDMA-AT drug session, participants undergo three to four min integration sessions, the first of which usually occurs the morning following the drug session. A library search was conducted by the primary author and recent systematic reviews were assessed to identify relevant literature for a critical synthesis. The first pilot trial was terminated prematurely and presents only limited descriptive data for six participants with no inter-group statistical comparison Buoso et al. The design, methods, results, and conclusions of all other extant trials are described below in order of publication. Table 1 presents a summary of relevant data from each trial. After study completion, an open-label crossover of MDMA-AT with two drug sessions was offered to those in the placebo condition, of which seven elected to take part. Participants, therapists, and independent outcome raters were blinded to study group in the initial phase, and participants and investigators guessed randomization group after treatment sessions. The investigators note that supplemental doses among the treatment group were accepted in 22 out of the 23 cases in which they were offered but did not specify the number of supplemental doses offered to and accepted by the control group. In all other respects, the therapeutic methodology mirrored that which is described in the treatment manual. Recruitment occurred via online advertisements and letters to therapists Mithoefer, Wagner, et al. An additional two subjects dropped out of the treatment condition after the first MDMA-AT drug session, and another was determined to have failed screening following randomization. The study's primary outcome measure was the CAPS. Non-physiological measures were administered at baseline, four days after drug sessions, and two months after the final drug session. Notable results of Mithoefer and colleagues' study included participant demographics, treatment side effects, efficacy findings, and blinding evaluation No serious adverse events were recorded, and side effects were mild and transient. No significant differences on neurocognitive measures were detected between groups pre- or post-treatment. Additional sessions for those in the treatment group did not significantly alter outcomes. Mithoefer and colleagues conclude that the results of the trial are promising, but that future studies should investigate methods for improving blinding and attempt to discern essential elements of the therapeutic approach Participants were first randomized to two groups, then control group subjects were offered the opportunity to take part in an open-label crossover. As the methods utilized by Oehen et al. Notably, due to lack of clinical response in several full-dose participants, a protocol amendment was sought to offer two additional treatment and six integration sessions to three non-responders in the treatment group. All participants in the control group participated in the open-label crossover, which utilized one preparatory session. Two treatment group participants dropped out after a single drug session; both were ethnic minorities. Results from Oehen and colleagues' trial were mixed Though the placebo and treatment group differed significantly on PDS scores, no significant difference was observed in average CAPS scores despite a score increase in the placebo group. Insomnia and loss of appetite were common adverse outcomes across study groups. Initial non-responders in the treatment group who consented to additional higher-dose sessions of MDMA-AT did not experience meaningful improvement. While the control group participants responded to treatment in the open-label crossover, statistical significance is not reported. The blinding evaluation revealed that slightly over half of subjects and therapists correctly predicted group assignment. The authors conclude by noting that while there was no significant difference between groups on the primary outcome measure, the administration of MDMA was safe. They suggest that future trials use three rather than two preparatory sessions to facilitate rapport-building. The ratio of preparation, drug, and integration sessions was in the initial treatment phase. Methodologically, Ot'alora et al. Blinded raters administered measures at baseline, one month after the second blinded session, one month after the second open-label session low-dose group , two months after the third open-label session, and at 12 months after the final treatment session. Primary and secondary outcomes reported by Ot'alora et al. The blinding evaluation revealed that most therapists and subjects correctly guessed group assignment. In their conclusion, the authors highlighted the discrepancy between the low-dose and full-dose groups on outcomes following a third treatment session of MDMA-AT and note that future research should aim to clarify the number of sessions required for maximum efficacy. Conducted with military veterans and first responders in the U. All groups were offered a supplemental dose of half the initial dose 2—2. Consistent with the design described by Ot'alora et al. Participants were again recruited via internet advertisement, referral, and word-of-mouth Mithoefer et al. At the conclusion of the randomized phase of the study, the active-dose groups typically outperformed the low-dose group across outcome measures Mitheofer et al. At the month follow-up, CAPS scores were lower among all subjects, though two participants experienced symptom recurrence. Across secondary measures, participants who completed the final assessment demonstrated significant improvements from baseline. Despite a high incidence of adverse events 85 among 20 participants , most were mild and only one severe adverse event was deemed to be plausibly related to MDMA-AT ventricle fibrillation. Perhaps unexpectedly, the therapeutic approach combined with inactive placebo has a salutary effect, despite its comparatively poor blinding Mithoefer, Wagner, et al. The authors concede that month outcome data cannot distinguish group effects due to the crossover design. The ratio of preparatory, drug, and integration sessions was , with one optional additional integration session. Due in large part to COVID, seven participants withdrew before completion of all treatment visits. Methods were typical of other trials Mitchell et al. Participants were primarily recruited via advertisement and referral, with standard inclusion and exclusion criteria regarding PTSD severity, chronicity, treatment resistance, and comorbidity. Blinded raters administered measures at baseline, three weeks after the first two drug sessions, and eight weeks after the final drug session. Attention was paid to a subset of adverse events of special interest to the FDA related to abuse liability, cardiac issues, and suicidality. MDMA-AT demonstrated equivalent efficacy across study sites, and across participants of various morbidity and comorbidity profiles. Treatment-emergent adverse events associated with cardiac function and suicidality were equal across study arms. The most recent randomized, controlled, multisite U. To this end, its design is nearly identical to the previous study Mitchell et al. The only noteworthy design change was the provision for a formal evaluation of blinding. Participants assigned to the active treatment condition outperformed those in the control arm on primary and secondary outcome measures at study closure Mitchell et al. Side effects among this sample were overwhelmingly common. The authors note that no adverse events included heightened risk for addiction or abuse of MDMA. The authors conclude by underscoring the positive efficacy findings of the trial and the tolerability of treatment Mitchell et al. In recent Phase III trials, observed between-group effect sizes are moderate to large and treatment effects are durable to a year post-intervention Mitchell et al. MDMA administration has been associated with few serious adverse events across all studies. It appears well-tolerated among healthy, young to middle-aged volunteers without medical comorbidities, though potentially risky among those with a prior history of poor cardiovascular health Mitchell et al. However, many features of these RCTs cloud the interpretation of results. Given the novelty of the complex psychotherapeutic approach and the lack of data on its individual efficacy in treating PTSD, it constitutes an unknown comparison. It is not possible to draw definitive conclusions about the efficacy of MDMA-AT as heretofore it has only been tested against versions of itself. Despite media claims to the contrary Morgan, , the fact remains that MDMA-AT treatment effect sizes, response rates, and rates of loss of diagnosis are similar to existing therapies Halvorsen et al. Interpretation of results must incorporate the approach's inconsistency across and within individual studies. Importantly, blinding across trials of MDMA-AT demonstrates that participants and therapists alike can correctly guess group assignment well above chance. Though comparison of MDMA-AT to a placebo version of the same therapy is circular, such a design could have been enhanced by using midazolam Grunebaum et al. The insufficient blinding raises the possibility of allegiance bias and expectancy effects. No trial to date has included a comparator arm with MDMA alone, the non-directive therapy alone, or MDMA with a sham version of the therapy, muddying the interpretation of their independent effects. With no comparative data on the value of a male and female co-therapist team, a comfortable, living-room style environment, preparatory and integration sessions, and overnight stays, evaluation of the approach's merits is difficult. Assessing which MDMA-AT components are essential is critical given the high resource and time demands of the approach. Notably, this does not account for drug costs, overnight accommodations with a trained attendant, or daily therapist phone contact for a week after treatment sessions. Per the MAPS website, the organization seeks both to conduct research trials to test the efficacy of psychedelic therapies, and to promote policy initiatives for the legalization and wider availability of psychedelic compounds Multidisciplinary Association for Psychedelic Studies MAPS. The obstacles associated with orchestrating lengthy, multisite trials of MDMA-AT, which involve use of a Schedule 1 compound, a complex treatment regimen, and a vulnerable patient population, are difficult to overstate Sessa et al. MAPS is so far the only organization that has proved equal to the challenge Morgan, Still, the organization's monopoly on this field of inquiry has raised questions about the validity and interpretability of MDMA-AT studies Bedi et al. Relatedly, the role of MAPS in the sampling of participants may also limit the generalizability of findings, as subjects who volunteer for MDMA-AT trials may be unduly influenced by inflated claims of the treatment's efficacy, allegiance to the organization's policy goals, and self-selection bias Bedi et al. Though perhaps not true to all participants' experiences, this vividly illustrates how potential selection bias, demand characteristics, response desirability effects, and commitment to the policy aims of MAPS among research subjects may skew results of RCTs of MDMA-AT. Though many trials demonstrate promising efficacy and safety results for MDMA-AT for PTSD, the literature to date is dominated by poorly blinded, circularly designed studies orchestrated by a single organization with apparent conflicting interests. MDMA-AT trials have perhaps further suffered from their own media success and the concurrent psychedelic renaissance in psychiatry, both of which may contribute to dramatically altered participant responses. Future studies should be undertaken by independent researchers to lessen the influence of allegiance bias and expectancy effects. Deconstruction studies and head-to-head trials are critical to understand which components of the intervention are central to efficacy and to compare MDMA-AT's efficacy to current, evidence-based treatments. Given the high costs of MDMA-AT, the simplification and streamlining of the treatment may promote greater treatment accessibility and enhance the feasibility of its widespread adoption. Clinical implications are unclear, given the many unanswered questions pertaining to MDMA-AT's mechanisms of action, the diversity of training competencies that are relevant to deliver the non-directive therapy, and the absence of any studies that directly compare MDMA-AT to current therapies Halvorsen et al. Widespread adoption is unwise until there is empirical support for its comparability to the available evidence-based treatments. The authors received no specific financial support for the research, preparation, or publication of this article. Hood, Alex: conceptualization, writing — original draft preparation, writing — review and editing. Elkins, Gary: writing — conceptualization, review and editing, project administration, supervision. Alexander , W. Pharmacotherapy for post-traumatic stress disorder in combat veterans: Focus on antidepressants and atypical antipsychotic agents. American Psychiatric Association. APA Diagnostic and statistical manual of mental disorders 4th ed. American Psychiatric Publishing, Inc. Position statement on the use of psychedelic and empathogenic agents for mental health conditions. Washington, DC : Alpert, J. Accessed 30 November from APA. Bahji , A. Efficacy of 3,4-methylenedioxymethamphetamine MDMA -assisted psychotherapy for posttraumatic stress disorder: A systematic review and meta-analysis. Progress in Neuro-Psychopharmacology and Biological Psychiatry , 96 , — Barber , G. The emerging field of psychedelic psychotherapy. Current Psychiatry Reports , 24 10 , — Barnett , B. United States National Institutes of Health grant funding for psychedelic-assisted therapy clinical trials from The International Journal on Drug Policy , 99 , Beck , A. Internal consistencies of the original and revised Beck depression inventory. Journal of Clinical Psychology , 40 6 , — Bedi , G. MDMA-assisted psychotherapy for post-traumatic stress disorder: The devil is in the detail. Australian and New Zealand Journal of Psychiatry , 57 4 , — Bisson , J. Psychological therapies for chronic post-traumatic stress disorder PTSD in adults. Cochrane Database Systematic Reviews , 12 , Cd Blanchard , E. A controlled evaluation of cognitive behavioural therapy for posttraumatic stress in motor vehicle accident survivors. Behaviour Research and Therapy , 41 1 , 79 — Bouso , J. MDMA-assisted psychotherapy using low doses in a small sample of women with chronic posttraumatic stress disorder. Journal of Psychoactive Drugs , 40 3 , — Buysse , D. The Pittsburgh Sleep quality index: A new instrument for psychiatric practice and research. Psychiatry Research , 28 2 , — Carlson , E. An update on the dissociative experiences scale. Dissociation: Progress in the Dissociative Disorders , 6 1 , 16 — Coles , T. Neuropsychiatric Disease and Treatment , 10 , — Conroy , J. Why people aren't getting the care they need. Monitor on Psychology , 51 5. Accessed 6 December from Monitor on Psychology. Davis , L. The economic burden of posttraumatic stress disorder in the United States from a societal perspective. Journal of Clinical Psychiatry , 83 3 , 1 — DeAngelis , T. Monitor on Psychology , 54 1. Accessed 30 November from Monitor on Psychology. Derogatis , L. SclR: Symptom checklistR: Administration, scoring and procedures manual 3rd ed. National Computer Systems. Dickinson , J. Why mental health researchers are studying psychedelics all wrong. Salon , 6 March. Accessed 29 November from Salon. Doblin , R. Journal of Psychoactive Drugs , 34 2 , — Feduccia , A. Discontinuation of medications classified as reuptake inhibitors affects treatment response of MDMA-assisted psychotherapy. Psychopharmacology , 2 , — First , M. Foa , E. The validation of a self-report measure of posttraumatic stress disorder: The Posttraumatic Diagnostic Scale. Psychological Assessment , 9 4 , — Gette , J. Modeling the adverse childhood experiences questionnaire-international version. Child Maltreatment , 27 4 , — Ginsberg , N. Godes , M. Perceived key change phenomena of MDMA-assisted psychotherapy for the treatment of severe PTSD: An interpretative phenomenological analysis of clinical integration sessions. Frontiers in Psychiatry , 14 , — Greer , G. A method of conducting therapeutic sessions with MDMA. Journal of Psychoactive Drugs , 30 4. Grunebaum , M. Ketamine for rapid reduction of suicidal thoughts in major depression: A midazolam-controlled randomized clinical trial. American Journal of Psychiatry , 4 , — Halvorsen , J. Challenges with benchmarking of MDMA-assisted psychotherapy. Nature Medicine , 27 10 , — Hopwood , T. A meta-analytic investigation of the impact of mindfulness-based interventions on posttraumatic stress. Clinical Psychology Review , 57 , 12 — Illingworth , B. European Psychiatry , 64 S1 , S — S Kim , S. Mind-body practices for posttraumatic stress disorder. Journal of Investigative Medicine , 61 5 , — Knopf , A. Psychiatry organization does not endorse psychedelic treatment. Alcoholism and Drug Abuse Weekly , 34 31 , 5 — 6. Wiley Periodicals, Inc. Landis-Shack , N. Music therapy for posttraumatic stress in adults: A theoretical review. Psychomusicology , 27 4 , — Cost-effectiveness of prolonged exposure therapy versus pharmacotherapy and treatment choice in posttraumatic stress disorder the optimizing PTSD treatment trial : A doubly randomized preference trial. Journal of Clinical Psychiatry , 75 3 , — Madero , S. European Neuropsychopharmacology , 70 , 19 — Marseille , E. Updated cost-effectiveness of MDMA-assisted therapy for the treatment of posttraumatic stress disorder in the United States: Findings from a phase 3 trial. PloS One , 17 2 , e McGreevy , S. Touch: An integrative review of a somatosensory approach to the treatment of adults with symptoms of post-traumatic stress disorder. European Journal of Integrative Medicine , 54 , Meara , K. Patient Care. Merz , J. Comparative efficacy and acceptability of pharmacological, psychotherapeutic, and combination treatments in adults with posttraumatic stress disorder: A network meta-analysis. JAMA Psychiatry , 76 9 , — Mitchell , J. Nature Medicine , 27 6 , — Nature Medicine , 29 10 , — Mithoefer , A. A manual for MDMA-assisted psychotherapy in the treatment of posttraumatic stress disorder: Version 4. Multidisciplinary Association for Psychedelic Studies. A manual for MDMA-assisted psychotherapy in the treatment of posttraumatic stress disorder: Version 8. Mithoefer , M. The Lancet. Psychiatry , 5 6 , — Journal of Psychopharmacology Oxford, England , 25 4 , — Morgan , L. Annals of General Psychiatry , 19 1 , 33— About MAPS. A manual for adherence ratings of MDMA-assisted therapy for treatment of posttraumatic stress disorder, Version 6. Murugesu , J. New Scientist , , 14— National Institute on Drug Abuse. NIDA , What is MDMA? Nogrady , B. BMJ Online , , p — Oehen , P. Journal of Psychopharmacology Oxford, England , 27 1 , 40 — Ot'alora , G. Journal of Psychopharmacology , 32 12 , — Parekh , S. Brain, Behavior, and Immunity. Health , 26 , — Posner , K. The Columbia-suicide severity rating scale: Initial validity and internal consistency findings from three multisite studies with adolescents and adults. American Journal of Psychiatry , 12 , — Ramchand , R. Prevalence of, risk factors for, and consequences of posttraumatic stress disorder and other mental health problems in military populations deployed to Iraq and Afghanistan. Current Psychiatry Report , 17 5 , Raut , S. Diverse therapeutic developments for post-traumatic stress disorder PTSD indicate common mechanisms of memory modulation. Ross , S. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: A randomized controlled trial. Journal of Psychopharmacology Oxford, England , 30 12 , — Schottenbauer , M. Psychiatry , 71 2 , — Schouten , K. The effectiveness of art therapy in the treatment of traumatized adults: A systematic review on art therapy and trauma. Sessa , B. Shaping the renaissance of psychedelic research. The Lancet British Edition , , — Frontiers in Psychiatry , 10 , Smith , K. Journal of Clinical Pharmacology , 62 4 , — Tedeschi , R. The posttraumatic Growth inventory: Measuring the positive legacy of trauma. Journal of Traumatic Stress , 9 3 , — Thakur , A. Current Molecular Pharmacology , 15 3 , — US Department of Veteran Affairs , n. How common is PTSD in adults? Accessed 30 November from VA. Weathers , F. Depression and Anxiety , 13 3 , — Weiss , D. The impact of event scale—revised. Keane Eds. The Guilford Press. Womperski , K. Journal of Education, Health and Sport , 43 1 , 82 — Cochrane Database of Systematic Reviews , 7. Attila Szabo - University of Oslo. E-mail address: attilasci gmail. Attila Szabo University of Oslo. Sign in Sign up. Advanced Search Help. Journal of Psychedelic Studies. Critical review of 3,4-methylenedioxymethamphetamine MDMA -assisted therapy for posttraumatic stress disorder: Unanswered questions and future directions. Authors: Alex P. Hood Alex P. Chris E. Corlett Chris E. Cameron T. Alldredge Cameron T. Gary R. Elkins Gary R. Open access. Download PDF. Check for updates. Methods A library search and analysis of extant literature reviews was conducted to identify publications containing original research findings with inter-group statistical comparisons from randomized, controlled trials of MDMA-AT. Schedule of activities of MDMA-AT Following screening, participants in MDMA-AT undergo two to three min preparatory sessions oriented toward familiarizing participants with the course of treatment, building rapport, and establishing expectations for drug sessions Mithoefer et al. Individual studies A library search was conducted by the primary author and recent systematic reviews were assessed to identify relevant literature for a critical synthesis. Table 1. Mithoefer et al. Mithoefer, Jerome, et al. Ot'alora et al. Mitchell et al. Critical synthesis However, many features of these RCTs cloud the interpretation of results. Conclusion Though many trials demonstrate promising efficacy and safety results for MDMA-AT for PTSD, the literature to date is dominated by poorly blinded, circularly designed studies orchestrated by a single organization with apparent conflicting interests. Funding sources The authors received no specific financial support for the research, preparation, or publication of this article. Authors' contribution Hood, Alex: conceptualization, writing — original draft preparation, writing — review and editing. Corlett, Chris: writing — review and editing, project administration. Alldredge, Cameron: writing — review and editing, visualization. Conflict of interest The authors have no conflicts of interest to disclose. Export References. Your current browser may not support copying via this button. Online ISSN: Attila Szabo University of Oslo E-mail address: attilasci gmail. Long-lasting analgesic effect of the psychedelic drug changa : A case report. Ketamine-assisted psychotherapy for trauma-exposed patients in an outpatient setting: A clinical chart review study. Authors: Alan K. Pratheek Mangini. Yitong Xin. Authors: Zoe W. Joel Lopez. Sara de la Salle. Sonya Faber. Monnica T. A potential role for psilocybin in the treatment of obsessive-compulsive disorder. Author: Edward Jacobs. Author: Sam Gandy. Authors: Elizabeth M. Jeffrey Guss. The oldest archeological data evidencing the relationship of Homo sapiens with psychoactive plants: A worldwide overview. Author: Giorgio Samorini. Authors: Andrew Yockey. Keith King. An ontology of psychedelic entity experiences in evolutionary psychology and neurophenomenology. Author: Michael James Winkelman. Subjective effectiveness of ibogaine treatment for problematic opioid consumption: Short- and long-term outcomes and current psychological functioning. Joseph P. Austin-Marley Windham-Herman. Marta Lynch. Martin Polanco. Our Blog Akademiai. Sign in to annotate. Delete Cancel Save. Cancel Save. View Expanded. View Table. View Full Size. Significant Findings. Two-arm RCT with open-label crossover. Oehen et al. Three-arm ascending dose RCT with open-label crossover.

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