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Thank you for visiting nature. You are using a browser version with limited support for CSS. To obtain the best experience, we recommend you use a more up to date browser or turn off compatibility mode in Internet Explorer. In the meantime, to ensure continued support, we are displaying the site without styles and JavaScript. Matters Arising to this article was published on 11 October 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 NCT to test the efficacy and safety of 3,4-methylenedioxymethamphetamine MDMA -assisted therapy for the treatment of patients with severe PTSD, including those with common comorbidities such as dissociation, depression, a history of alcohol and substance use disorders, and childhood trauma. Adverse events and suicidality were tracked throughout the study. These data indicate that, compared with manualized therapy with inactive placebo, MDMA-assisted therapy is highly efficacious in individuals with severe PTSD, and treatment is safe and well-tolerated, even in those with comorbidities. We conclude that MDMA-assisted therapy represents a potential breakthrough treatment that merits expedited clinical evaluation. PTSD is a common and debilitating condition with immeasurable social and economic costs that affects the lives of hundreds of millions of people annually. There are a number of environmental and biological risk factors that contribute to the development and maintenance of PTSD 1 , and poor PTSD treatment outcomes are associated with several comorbid conditions that include childhood trauma 2 , alcohol and substance use disorders 3 , depression 4 , suicidal ideation 5 and dissociation 6. It is therefore imperative to identify a therapeutic that is beneficial in those individuals with the comorbidities that typically confer treatment resistance. Likewise, although evidenced-based trauma-focused psychotherapies such as prolonged exposure and cognitive behavioral therapy are considered to be the gold standard treatments for PTSD 8 , many participants fail to respond or continue to have significant symptoms, and dropout rates are high 9 , Novel cost-effective therapeutics are therefore desperately needed The substituted amphetamine 3,4-methylenedioxymethamphetamine MDMA induces serotonin release by binding primarily to presynaptic serotonin transporters MDMA has been shown to enhance fear memory extinction, modulate fear memory reconsolidation possibly through an oxytocin-dependent mechanism , and bolster social behavior in animal models 13 , Participants were given three doses of MDMA or placebo in a controlled clinical environment and in the presence of a trained therapy team. Primary and secondary outcome measures CAPS-5 and SDS, respectively were assessed by a centralized pool of blinded, independent diagnostic assessors. Participants were recruited from 7 November to 26 May , with the last participant visit conducted on 21 August Study arms were not significantly different in terms of race, ethnicity, sex, age, dissociative subtype, disability or CAPS-5 score Table 1. The mean duration of PTSD diagnosis was Primary analysis was completed using least square means from an MMRM model. Data are presented as mean and s. When the within-group treatment effect which included the effect of the supportive therapy that was administered in both arms was compared between the MDMA and placebo groups, the effect size was 2. MDMA was equally effective in participants with comorbidities that are often associated with treatment resistance. The benefit of MDMA therapy was not modulated by history of alcohol use disorder, history of substance use disorder, overnight stay or severe childhood trauma. Withdrawal is defined as a post-randomization early termination. Treatment-emergent adverse events TEAEs, adverse events that occurred during the treatment period from the first experimental session to the last integration session that were more prevalent in the MDMA study arm were typically transient, mild to moderate in severity, and included muscle tightness, decreased appetite, nausea, hyperhidrosis and feeling cold Supplementary Table 3. Importantly, no increase in adverse events related to suicidality was observed in the MDMA group. A transient increase in vital signs systolic and diastolic blood pressure and heart rate was observed in the MDMA group Supplementary Table 4. Two participants in the MDMA group had a transient increase in body temperature to Two participants, both randomized to the placebo group, reported three serious adverse events SAEs during the trial. One participant in the placebo group reported two SAEs of suicidal behavior during the trial, and another participant in the placebo group reported one SAE of suicidal ideation that led to self-hospitalization. Five participants in the placebo group and three participants in the MDMA group reported adverse events of special interest AESIs of suicidal ideation, suicidal behavior or self-harm in the context of suicidal ideation. One participant in the placebo group reported two cardiovascular AESIs in which underlying cardiac etiology could not be ruled out Table 2. One participant randomized to the MDMA group chose to discontinue participation due to being triggered by the CAPS-5 assessments and to an adverse event of depressed mood following an experimental session; this participant met the criterion as a non-responder, which was defined as having a less than point decrease in CAPS-5 score. MDMA sessions were not otherwise followed by a lowering of mood. Although the number of participants who reported suicidal ideation varied throughout the visits, prevalence never exceeded baseline and was not exacerbated in the MDMA group. Serious suicidal ideation a score of 4 or 5 on the C-SSRS was minimal during the study and occurred almost entirely in the placebo arm Fig. C-SSRS ideation scores range from 0 no ideation to 5. The number of participants endorsing serious ideation is given in parentheses in the table. Of note, MDMA did not increase the occurrence of suicidality during the study. These data illustrate the potential benefit of MDMA-assisted therapy for PTSD over the FDA-approved first-line pharmacotherapies sertraline and paroxetine, which have both exhibited smaller effect sizes in pivotal studies Previous comparison of change in CAPS score between sertraline and placebo showed effect sizes of 0. Similarly, comparison of change in CAPS score between paroxetine and placebo showed effect sizes of 0. By contrast, the effect size of 0. Given that However, there was no obvious effect of previous SSRI use on therapeutic efficacy in this trial. Similarly, although years of PTSD diagnosis or age of onset may affect treatment efficacy, no obvious relationship was seen here between duration or onset of PTSD diagnosis and treatment efficacy. Serotonin and the serotonin transporter are of particular importance in the generation, consolidation, retrieval and reconsolidation of fear memories 19 , Reduced serotonin transporter levels which result in greater amounts of extracellular serotonin have been shown to predict propensity to develop PTSD 21 , increase fear and anxiety-related behaviors 22 , and induce greater amygdalar blood oxygenation level-dependent BOLD activity in response to fearful images There is extensive serotonergic innervation of the amygdala, and amygdalar serotonin levels have been shown to increase following exposure to stressful and fear-inducing stimuli MDMA enhances the extinction of fear memories in mice through increased expression of brain-derived neurotrophic factor in the amygdala, and human neuroimaging studies have demonstrated that MDMA is associated with attenuated amygdalar BOLD activity during presentation of negative emotional stimuli Together these data suggest that MDMA may exert its therapeutic effects through a well-conserved mechanism of amygdalar serotonergic function that regulates fear-based behaviors and contributes to the maintenance of PTSD. Perhaps by reopening an oxytocin-dependent critical period of neuroplasticity that typically closes after adolescence 15 , MDMA may facilitate the processing and release of particularly intractable, potentially developmental, fear-related memories. MDMA-assisted therapy may facilitate recall of negative or threatening memories with greater self-compassion 27 and less PTSD-related shame and anger Additionally, the acute prosocial and interpersonal effects of MDMA 25 , 29 may support the quality of the therapeutic alliance, a potentially important factor relating to PTSD treatment adherence 30 and outcome Approximately 4. Identification of a PTSD treatment that could improve social and family functioning and ameliorate impairment across a broad range of environmental contexts could provide major medical cost savings, in addition to improving the quality of life for veterans and others affected by this disorder. PTSD is a particularly persistent and incapacitating condition when expressed in conjunction with other disorders of mood and affect. In the present study, perhaps most compelling are the data indicating efficacy in participants with chronic and severe PTSD, and the associated comorbidities including childhood trauma, depression, suicidality, history of alcohol and substance use disorders, and dissociation, because these groups are all typically considered treatment resistant 2 , 3 , 4 , 5 , 6. Additional studies should therefore be conducted to evaluate the safety and efficacy of MDMA-assisted therapy for PTSD in those with specific comorbidities. Although recent research suggests that dissociative subtype PTSD is difficult to treat 36 , participants with the dissociative subtype who received MDMA-assisted therapy had significant symptom reduction that was at least similar to that of their counterparts with non-dissociative PTSD. Given that this covariate was significant, it warrants further study. Furthermore, given that other treatments for PTSD are not consistently effective for those with the dissociative subtype, these data, if replicated, would indicate an important novel therapeutic niche for MDMA-assisted therapy for typically hard-to-treat populations. Importantly, there were no major safety issues reported in the MDMA arm of this study. Although abuse potential, cardiovascular risk and suicidality were recorded as AESIs, MDMA was not shown to induce or potentiate any of these conditions. In addition, although there was often a transient increase in blood pressure during MDMA sessions, this was expected based on phase 2 data and previous studies in healthy volunteers There are several limitations to the current trial. First, due to the coronavirus disease COVID pandemic, the participant population is smaller than originally planned. However, given the power noted in this study, it is unlikely that population size was an impediment. Second, the population is relatively homogeneous and lacks racial and ethnic diversity, which should be addressed in future trials. Fourth, safety data were by necessity collected by site therapists, perhaps limiting the blinding of the data. To eliminate this effect on the primary and secondary outcome measures, all efficacy data were collected by blinded, independent raters. Last, given the subjective effects of MDMA, the blinding of participants was also challenging and possibly led to expectation effects Although anecdotal, at least 7 of 44 participants in the placebo group Overwhelmingly high rates of psychological and mental health impairment could be with us for years to come and are likely to impart a considerable emotional and economic burden. Novel PTSD therapeutics are desperately needed, especially for those for whom comorbidities confer treatment resistance. In summary, MDMA-assisted therapy induces rapid onset of treatment efficacy, even in those with severe PTSD, and in those with associated comorbidities including dissociative PTSD, depression, history of alcohol and substance use disorders, and childhood trauma. Compared with current first-line pharmacological and behavioral therapies, MDMA-assisted therapy has the potential to dramatically transform treatment for PTSD and should be expeditiously evaluated for clinical use. This was a randomized double-blind study designed to compare the efficacy of MDMA-assisted therapy with that of placebo with therapy. Fifteen study sites, consisting of 11 in the United States, two in Canada and two in Israel, included both institutional sites and private clinics. This clinical study was conducted in accordance with the principles of the Declaration of Helsinki. Participants were recruited through print and internet advertisements, referrals from treatment providers, and by word of mouth. Participants were required to initiate contact with the study sites themselves, even if recommended by a provider. After providing written informed consent, participants were screened for eligibility. Participants with other mild, stable, chronic medical problems for example, type 2 diabetes mellitus or well-controlled hypertension were eligible for enrollment if the site physician, clinical investigator and medical monitor agreed that the condition would not increase the risk associated with MDMA administration. Participants were required to comply with lifestyle modifications, including a medically supervised discontinuation of psychiatric medications for a minimum of five half-lives plus one additional week before the baseline assessments see the study protocol for inclusion and exclusion criteria. The study protocol was amended on three occasions during study enrollment: first, to add clarity to eligibility criteria related to comorbid medical conditions; second, to add terms of suicidal ideation and behavior as AESIs, as requested by the FDA; and third, to increase the frequency of suicidality assessments following experimental sessions, as requested by the FDA, and to add an option for some telemedicine visits following the COVID pandemic. Participants were randomized in a blinded fashion and were allocated to either the MDMA-assisted therapy group or the placebo with therapy group. Randomization was stratified by site and occurred following enrollment confirmation after preparatory visits. Participants, site staff and the sponsor were blinded to participant group assignment until after the database was locked. An inactive placebo with therapy was utilized as the comparator to isolate the efficacy of the MDMA itself. Although low-dose MDMA improved blinding in phase 2 studies, it led to decreased effectiveness compared with an inactive placebo in a PTSD population, making it easier to detect a difference between the active and comparator groups The use of inactive placebo also allows for uncontaminated comparison of safety data between groups. Therefore, an inactive placebo was determined in partnership with the FDA as a more conservative statistical comparison, and the study utilized observer-blinded efficacy assessments to minimize bias in efficacy measurements. An observer-blind and centralized independent rater pool was used to administer the primary and secondary outcome measures, that is, the CAPS-5 and the SDS for functional impairment, the latter of which was adapted to limit missing item-level data as per the FDA requirements and included use of the three-item mean as the total score and imputation of work-related impairment as the maximum score, if caused by PTSD. The independent rater measurements were conducted at baseline and following each experimental session via live video interviews. Independent raters did not repeatedly see the same participant and the independent rater pool was blinded to the complete study design, visit number, treatment assignment, and all data collected by the therapy team after baseline, with the exception of safety data related to suicidality. Participants were instructed to withhold their opinion on treatment group assignment from independent raters and to refrain from sharing details regarding the study design and their number of completed visits. To ensure that all site and sponsor staff were shielded from study outcome measures, primary and secondary outcome measures were collected from the blinded independent rater pool and stored in a dedicated database that was separate from the blinded, clinical database. Following an initial phone screening, participants provided written informed consent and underwent further screening assessments for eligibility. Study staff contacted outside providers, ordered medical records, and conducted a physical examination, laboratory testing including pregnancy and drug tests , electrocardiogram, and 1-min rhythm strip. Eligible participants were enrolled in the study and began psychiatric medication taper Table 1 if needed, and collection of adverse events. Anticipated effects of MDMA, such as euphoria, stimulation and feelings of closeness 39 , were intentionally not solicited as adverse events to avoid biasing the collection of adverse event data. In accordance with FDA guidance, we paid special attention to a subset of adverse events, termed AESIs, relating to cardiac function that could be indicative of QT interval prolongation or cardiac arrhythmias, abuse liability, and suicidal ideation and behavior. All adverse events that included signs or symptoms potentially associated with a cardiovascular event such as palpitations or dizziness were further evaluated for reporting as a cardiovascular adverse event. Suicidal ideation that was judged as serious or severe by the investigator, serious ideation defined as a C-SSRS suicidal ideation score of a 4 or 5, self-harm in the context of any suicidal ideation, and any suicide attempts were reported as AESIs. Enrolled participants underwent three min preparatory sessions of therapy with a two-person therapist team in preparation for experimental sessions Fig. The preparatory sessions focused on establishing therapeutic alliance and trust, and also provided guidance on how to respond to the memories and feelings that could arise during treatment. Participants who failed to meet all eligibility criteria were withdrawn during this preparatory period. At the end of the preparatory period, participants were assessed for final eligibility and enrollment was confirmed prior to randomization Fig. Following a h fast, experimental sessions began with a qualitative urine drug screen, pregnancy screen if applicable, and C-SSRS, as well as measurement of baseline blood pressure, body temperature and heart rate immediately before the initial drug dose. Any positive findings on the urine drug screen that could not be attributed to pre-approved concomitant medications were reviewed by the medical monitor to assess compliance with ongoing eligibility criteria and for possible AESIs. There were no instances in which the supplemental dose was withheld due to tolerability issues. Blood pressure, body temperature and heart rate were measured before the supplemental dose was given Blood pressure, body temperature and heart rate were measured at the end of each experimental session prior to discharging the participant. Twenty per cent of independent rater assessments were randomly selected and reviewed for fidelity. Cases of non-compliance, protocol deviations, loss to follow-up, and other reasons for participant dropout were assessed for the presence of AESIs. There were two major protocol deviations defined as the eligibility criteria not being met by the randomized participants during the course of the study. In the first protocol deviation a participant was not compliant with drug use lifestyle modifications on study, and in the second protocol deviation a participant disclosed cannabis use at study entry but abstained for the duration of the study. Additionally, 14 participants 10 of whom were in the MDMA arm requested further integrative visits, as permitted by the protocol. The CAPS-5 is a semi-structured interview that assesses the index history of DSMdefined traumatic event exposure, including the most distressing event, to produce a diagnostic score presence versus absence and a PTSD total severity score. The CAPS-5 rates intrusion symptoms intrusive thoughts or memories , avoidance, cognitive and mood symptoms, arousal and reactivity symptoms, duration and degree of distress, and dissociation. Participants agreed to be recontacted for potential enrollment in a long-term follow-up study, which will include follow-up measures to assess the durability of the treatment. These data will be published at a later date. Statistical power calculations for the initial sample size were made by fitting an MMRM of CAPS-4 data converted to the CAPS-5 scale and pooled from the phase 2 studies to obtain variance and covariance parameter estimates. The intent-to-treat ITT set consisted of 91 randomized participants, however, one participant declined dosing on the morning of the session and provided no additional data, and therefore it was not possible to complete this analysis. Participants were randomized in a blinded fashion with allocation as described in the section on randomization, masking and bias minimization above. The modified intent-to-treat mITT set consisted of 90 randomized participants who had completed at least one blinded experimental session and at least one post-treatment assessment. The mITT set consisted of 46 participants randomized to the MDMA group and 44 participants randomized to the placebo group, with identical therapy. The SAP was guided by the ICH E9 R1 guidelines, which describe the use of estimands and sensitivity analyses to measure the effects of the drug if taken as directed de jure, assessment of efficacy , and the effects of the drug if taken as assigned, regardless of adherence de facto, assessment of effectiveness. The de jure dataset did not include outcome measurements taken after treatment discontinuation in the analysis of treatment efficacy. Missing data were not imputed. The de facto estimand assessed the impact of these missing data points in the mITT set. The primary and secondary efficacy analyses were carried out using an MMRM that included all outcome data from baseline and the first, second and third experimental sessions. The efficacy of treatment was tested by comparing the change from baseline to the third experimental session in CAPS-5 and SDS scores between treatment groups in two-sided tests. The fixed effects were treatment MDMA or placebo , baseline CAPS score, dissociative subtype and investigational site, with random effect specified as study participant. A hierarchical testing strategy was used to control for type I error, such that the hypothesis for the key secondary endpoint SDS would be tested only if the statistical test for the primary efficacy comparison rejected the null hypothesis. An analysis of covariance ANCOVA to test the effects of study participation before versus after the COVID pandemic declaration by the World Health Organization indicated a non-significant interaction and therefore was not included in the primary outcome model Supplementary Table 2. The primary outcome analysis was replicated independently by one blinded programmer and one unblinded programmer. The alpha level was set to 0. BDI-II score was also assessed as an exploratory efficacy outcome measure with a paired, two-tailed t -test. Results are reported as mean s. SAS version 9. The safety analysis included all participants who were given at least one dose of the study drug or placebo. The primary safety analysis evaluated TEAEs as a participant-level analysis. Further information on research design is available in the Nature Research Reporting Summary linked to this article. The data that support the findings of this study are available from the sponsor MAPS. However, restrictions apply to the availability of these data, which were used under license for the current study, and so are not publicly available. All requests for raw and analyzed data are promptly reviewed by the sponsor delegate and trial organizer, MAPS PBC, to verify if the request is subject to any confidentiality obligations. Patient-related data not included in the paper were generated as part of clinical trials and may be subject to patient confidentiality. Any data that can be shared will be released via a data use agreement. Commercially available software SAS version 9. Yehuda, R. Putative biological mechanisms for the association between early life adversity and the subsequent development of PTSD. Psychopharmacology Berl. Widom, C. Posttraumatic stress disorder in abused and neglected children grown up. Psychiatry , — Kessler, R. Posttraumatic stress disorder in the National Comorbidity Survey. Psychiatry 52 , — Hegel, M. Impact of comorbid panic and posttraumatic stress disorder on outcomes of collaborative care for late-life depression in primary care. Psychiatry 13 , 48—58 Article Google Scholar. Tarrier, N. Cognitive-behavioral interventions to reduce suicide behavior: a systematic review and meta-analysis. Wolf, E. The influence of the dissociative subtype of posttraumatic stress disorder on treatment efficacy in female veterans and active duty service members. Steenkamp, M. Psychotherapy for military-related PTSD: a review of randomized clinical trials. JAMA , — Watkins, L. Treating PTSD: a review of evidence-based psychotherapy interventions. Front Behav. Bisson, J. Psychological therapies for chronic post-traumatic stress disorder PTSD in adults. Cochrane Database Syst. PubMed Central Google Scholar. Gutner, C. Time course of treatment dropout in cognitive-behavioral therapies for posttraumatic stress disorder. Trauma 8 , — Marseille, E. Rudnick, G. Natl Acad. USA 89 , — Hake, H. Nardou, R. Oxytocin-dependent reopening of a social reward learning critical period with MDMA. Nature , — Mithoefer, M. 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. Feduccia, A. Breakthrough for trauma treatment: safety and efficacy of MDMA-assisted psychotherapy compared to paroxetine and sertraline. Psychiatry 10 , Lee, D. Psychotherapy versus pharmacotherapy for posttraumatic stress disorder: systematic review and meta-analyses to determine first-line treatments. Anxiety 33 , — Discontinuation of medications classified as reuptake inhibitors affects treatment response of MDMA-assisted psychotherapy. Bauer, E. Serotonin in fear conditioning processes. Brain Res. Johnson, P. Assessment of fear and anxiety associated behaviors, physiology and neural circuits in rats with reduced serotonin transporter SERT levels. Psychiatry 9 , 33 Lee, H. Influence of the serotonin transporter promoter gene polymorphism on susceptibility to posttraumatic stress disorder. Anxiety 21 , — Lesch, K. Association of anxiety-related traits with a polymorphism in the serotonin transporter gene regulatory region. Science , — Hariri, A. Serotonin transporter genetic variation and the response of the human amygdala. Kawahara, H. Psychological stress increases serotonin release in the rat amygdala and prefrontal cortex assessed by in vivo microdialysis. Bedi, G. Effects of MDMA on sociability and neural response to social threat and social reward. Frewen, P. Toward a psychobiology of posttraumatic self-dysregulation: reexperiencing, hyperarousal, dissociation, and emotional numbing. NY Acad. Kamboj, S. Dewey, D. Do peritraumatic emotions differentially predict PTSD symptom clusters? Initial evidence for emotion specificity. Hysek, C. MDMA enhances emotional empathy and prosocial behavior. Keller, S. Understanding factors associated with early therapeutic alliance in PTSD treatment: adherence, childhood sexual abuse history, and social support. Imel, Z. Meta-analysis of dropout in treatments for posttraumatic stress disorder. Mithoefer M. Fortenbaugh, F. Stress 33 , — Bureau of Labor and Statistics. Employment Situation of Veterans— Congressional Budget Office. Cloitre, M. An examination of the influence of a sequential treatment on the course and impact of dissociation among women with PTSD related to childhood abuse. Anxiety 29 , — Vizeli, P. Safety pharmacology of acute MDMA administration in healthy subjects. Funk, K. Bershad, A. Weathers, F. Download references. The authors thank all of the participants who screened for and participated in this challenging research study, and acknowledge the oversight of the principal investigators, T. Puri University of British Columbia, Canada. The authors thank the study coordinators S. Sadler, K. Brown, C. Marsicano, M. Wimsatt, B. Bendixsen, D. Bissell, S. Serice, M. Gaffigan, C. Miller, R. Bacigalupi, B. Deyo, A. Baltes, T. Baron, L. Owens, S. Robison, D. Gumpel, C. Battistelli, A. Samkavitz, K. Blommaert, A. Menier, D. Katz, E. Pushkarski, N. Somech and M. Bar Haim for their work at their respective study sites. The authors are especially grateful to Charleston study coordinator S. Sadler, who passed away prior to the end of this study after a decade of work on this and several prior Multidisciplinary Association for Psychedelic Studies MAPS clinical trials. The authors also acknowledge the following study therapists for their skillful treatment of study participants: S. Braswell, W. Reynolds, C. Reusche, E. Passow, S. Gael Giron, D. May, J. Beachy, K. Cooper, A. Schnaitter, C. Hancock, C. Heacock, B. Balliett, E. Siegal, N. Kraft, A. Booth, J. McCowan, S. Taylor, M. Skellie, Z. Hippel, M. Alavi, C. Stauffer, D. McDivitt, A. Rosati, K. Peoples, E. Sola, A. Penn, S. Sienknecht, G. Herzberg, H. Schwartz, V. Gold, J. Andries, C. Thomas, S. Ross, J. Guss, J. Duane, E. Nielson, K. Hall, E. Nielson, P. Lister, E. Horowitz, A. Belser, J. Silverman, S. Walker, J. Hopper, M. Alpert, F. Guerriero, A. Goar, E. Call, C. Jackson, J. Simundic, H. Rubensohn, K. Lutz, S. Adams, T. Nachsoni, N. Halberstadt, D. Dogon, K. The authors thank the site physicians, nurses, research assistants, volunteers, night attendants, physical examiners and all site staff who contributed their time and effort to the study. Brown and G. Fortier, for their work in clinical trial management; A. Nary, P. Perl, E. Shainer, A. Pace and S. Ndukwe for careful monitoring of study data; A. Schwind, P. Llorach, M. Leighton, D. Iszak, S. Ramey-Wright and E. Gworek for tireless support of the study administration; S. Garcia-Velazquez for her review of participant safety data; J. Lindgren for coordination of IRB submissions; E. Heimler for dedicated effort in coordinating the independent rater pool; A. Wang, J. Lin and A. Garcia for overseeing the adherence rating and supervision programs; S. Scheld for supporting therapist and supervisor training and the development of the Code of Ethics; J. Poncini, C. Shelley, M. Tromba and A. Clouting, B. Melton and K. Cohn for coordinating drug supply; A. Feduccia for her work on the phase 2 program that paved the way for this phase 3 trial; and C. Hennigan for the creation of the clinical databases. The authors also thank G. More for statistical programming, the teams of independent raters for their attention to detail and care for participants during outcome assessments, and the adherence raters for their close evaluation of the therapeutic delivery. No compensation was provided beyond normal compensation of employment. This clinical trial was sponsored by MAPS, a c 3 non-profit organization. MAPS PBC provided the study design and the monitoring of study data; analysis, management and interpretation of data; reviewed and approved the paper; and submitted the paper for publication. The funder had no role in the collection of data or in conducting the study. Jennifer M. You can also search for this author in PubMed Google Scholar. Correspondence to Jennifer M. The authors declare the following financial competing interests: A. The following authors disclose receipt of personal fees or grants from companies in the field, but unrelated to the present work: M. Fluence and Mindbloom , J. Filament Ventures and Silo Pharmaceuticals , and J. Usona Institute. The following authors disclose non-financial relationships with organizations in the field: M. Peer review information Nature Medicine thanks Philip Cowen, Kirsty James and the other, anonymous, reviewer s for their contribution to the peer review of this work. Jerome Staal was the primary editor on this article and managed its editorial process and peer review in collaboration with the rest of the editorial team. Reprints and permissions. Mitchell, J. Nat Med 27 , — Download citation. Received : 05 February Accepted : 02 April Published : 10 May Issue Date : June Anyone you share the following link with will be able to read this content:. Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative. Sign up for the Nature Briefing newsletter — what matters in science, free to your inbox daily. Skip to main content Thank you for visiting nature. Download PDF. Abstract Post-traumatic stress disorder PTSD presents a major public health problem for which currently available treatments are modestly effective. Trauma-focused treatment for comorbid post-traumatic stress and substance use disorder Article 14 November Behavioral and neurocognitive factors distinguishing post-traumatic stress comorbidity in substance use disorders Article Open access 14 September Main PTSD is a common and debilitating condition with immeasurable social and economic costs that affects the lives of hundreds of millions of people annually. Results Demographics Participants were recruited from 7 November to 26 May , with the last participant visit conducted on 21 August Full size image. Table 1 Demographics and baseline characteristics Full size table. Methods Study design This was a randomized double-blind study designed to compare the efficacy of MDMA-assisted therapy with that of placebo with therapy. Participants Participants were recruited through print and internet advertisements, referrals from treatment providers, and by word of mouth. Randomization, masking and bias minimization Participants were randomized in a blinded fashion and were allocated to either the MDMA-assisted therapy group or the placebo with therapy group. Procedures Following an initial phone screening, participants provided written informed consent and underwent further screening assessments for eligibility. Follow-up Participants agreed to be recontacted for potential enrollment in a long-term follow-up study, which will include follow-up measures to assess the durability of the treatment. Statistics and reproducibility Statistical power calculations for the initial sample size were made by fitting an MMRM of CAPS-4 data converted to the CAPS-5 scale and pooled from the phase 2 studies to obtain variance and covariance parameter estimates. Reporting Summary Further information on research design is available in the Nature Research Reporting Summary linked to this article. Data availability The data that support the findings of this study are available from the sponsor MAPS. Code availability Commercially available software SAS version 9. References Yehuda, R. Article Google Scholar Tarrier, N. Article Google Scholar Wolf, E. Article Google Scholar Steenkamp, M. Article Google Scholar Bisson, J. Article Google Scholar Marseille, E. Article Google Scholar Lee, D. Article Google Scholar Lee, H. Article Google Scholar Kamboj, S. Article Google Scholar Hysek, C. Article Google Scholar Keller, S. Article Google Scholar Imel, Z. Article Google Scholar Mithoefer M. Article Google Scholar Vizeli, P. Article Google Scholar Download references. Acknowledgements The authors thank all of the participants who screened for and participated in this challenging research study, and acknowledge the oversight of the principal investigators, T. Mitchell View author publications. View author publications. Ethics declarations Competing interests The authors declare the following financial competing interests: A. Additional information Peer review information Nature Medicine thanks Philip Cowen, Kirsty James and the other, anonymous, reviewer s for their contribution to the peer review of this work. Supplementary information. Supplementary Information Supplementary Tables 1—4. Reporting Summary. About this article. Cite this article Mitchell, J. Copy to clipboard. Menkes Trials What should constitute a control condition in psychedelic drug trials? Vannoy Sonja Lyubomirsky Scientific Reports Search Search articles by subject, keyword or author. Show results from All journals This journal. Advanced search. Close banner Close. 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