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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. An Author Correction to this article was published on 07 October 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. Overall, Participants were ethnoracially diverse: 28 of There were no deaths or serious TEAEs. Managing PTSD is particularly complicated in individuals experiencing the dissociative subtype of PTSD, recurrent exposure to trauma and comorbidities, such as mood disorders and alcohol and substance use disorders 2 , 3 , 4. Together, these factors are associated with symptom exacerbation, treatment resistance and treatment discontinuation 3 , 5. Trauma-focused psychotherapies are the gold standard treatment for PTSD. However, many individuals have persisting symptomology, and dropout rates are high 6 , 7 , 8. More effective, therapeutic interventions are needed to address the immense individual, societal and economic burdens of PTSD 10 , MDMA, an entactogen that promotes monoamine reuptake inhibition and release primarily by inducing conformational change of pre-synaptic transporters 14 , 15 , 16 , 17 , effectively modulates fear memory reconsolidation, enhances fear extinction and promotes openness and prosocial behavior 18 , 19 , 20 , 21 , Due to disparities in trauma exposure, gender-diverse and transgender individuals, ethnoracial minorities, first responders, military personnel, veterans and victims of chronic sexual abuse have a disproportionately higher risk of developing PTSD 2 , 23 , 24 , 25 , 26 , 27 , However, these diverse populations are historically underrepresented in clinical trials Participants were recruited from 21 August to 18 May last participant visit on 2 November Overall, individuals were screened, and were enrolled. Of these, 17 individuals did not meet enrollment confirmation after initiation of preparation therapy, and were confirmed for randomization: 53 were assigned to MDMA-AT and 51 to placebo with therapy Fig. Baseline characteristics were generally similar between groups Table 1. In total, 74 of Participants were ethnically and racially diverse: 35 of The mean s. Overall, 28 of Source data. Improvements were observed across all domains, including family life, social life and work life Supplementary Table 4. By study end, 37 of 52 Furthermore, 24 of 52 The net number of participants needed to treat for each responder analysis group was as follows: responder, six; non-responder, six; loss of diagnosis, four; remission, four. Covariate analyses demonstrated similar responses to treatment regardless of disease severity, risk of hazardous alcohol or substance use disorder, severe adverse childhood experiences or dissociative subtype PTSD. A blinding survey conducted at study termination showed that 33 of 44 None had a serious TEAE. Two participants 3. These were mostly transient and of mild or moderate severity. Participants in the MDMA-AT group experienced temporary dose-dependent increases in mean blood pressure BP and pulse during experimental sessions compared to the placebo with therapy group Supplementary Table 8. Transient increases in heart rate and BP were expected and were observed during experimental sessions in a dose-dependent manner. These transient elevations did not require clinical intervention, including among the subset of participants with well-controlled hypertension. Because the current dosing regimen involves administering a single, split drug dose under observation, for a limited number of times, each after a lengthy washout, cardiovascular risk is likely to have been sufficiently mitigated by the study procedures and screening measures. No severe TEAEs of suicidal ideation or behavior were reported. Two participants in the placebo with therapy group had suicidality TEAESIs; one engaged in non-suicidal self-injurious behavior, and one had suicidal ideation and trichotillomania Supplementary Table 9. The number of participants reporting positive suicidal ideation varied throughout the study but collectively never exceeded baseline values in either group Supplementary Fig. Of these, one participant in the MDMA-AT group with no suicidal ideation at baseline had the emergence of active suicidal ideation with at least some intent to act. Notably, 45 of 52 In a historic first, to our knowledge, for psychedelic treatment studies, participants who identified as ethnically or racially diverse encompassed approximately half of the study sample. These findings confirm and extend the results observed in MAPP1 ref. Given the diverse population and degree of participant complexity, the replication of efficacy is particularly notable. In our study, A substantial proportion of participants displayed comorbid features associated with high treatment resistance 5 , such as major depression, multiple sources of trauma including childhood and combat trauma and dissociative subtype PTSD. In keeping with MAPP1, treatment was not significantly affected by disease severity, risk of hazardous alcohol or substance use disorder, severe adverse childhood experiences or dissociative subtype. Furthermore, there was no observed site-to-site variability and no differential effect if participants stayed overnight after the experimental session. MDMA simultaneously induces prosocial feelings and softens responses to emotionally challenging and fearful stimuli 19 , potentially enhancing the ability of individuals with PTSD to benefit from psychotherapy by reducing sensations of fear, threat and negative emotionality 18 , In contrast, a recent study comparing psychotherapies in veterans with PTSD reported dropout rates of The MAPP2 dropout rate was 1. The higher proportion of dropouts in the placebo with therapy group relative to MDMA-AT could be attributed to participants receiving less effective treatment and to disappointment from ineffective therapeutic blinding, although blinding survey data showed that not all participants correctly identified the treatment that they received. Consistent with MAPP1, no new major safety issues were reported. Consistent with PTSD, suicidal ideation was observed in both groups. MDMA did not appear to increase this risk, and no suicidal behavior was observed. C-SSRS scores varied throughout the study but never exceeded baseline values for either group. MAPP2 enrolled participants with a history of suicidality but excluded those with a current, serious imminent suicide risk; thus, special attention to this vulnerable population is warranted in future studies. In alignment with MAPP1 ref. Long-term data are also needed to assess the risk of MDMA abuse or misuse after study participation. To support these studies, data from the ongoing follow-up of participants from phase 2 and 3 studies ClinicalTrials. Several limitations may impact the integration of MDMA-AT into clinical care, including the exclusion of participants with high suicide risk, comorbid personality disorders and underlying cardiovascular disease. The notable effect seen in the placebo with therapy arm could suggest the standalone value of the manualized inner-directed therapy that was developed for use with MDMA. Additional head-to-head studies will need to be conducted to evaluate whether this form of manualized therapy provides greater value in the treatment of PTSD than the current first-line cognitive behavioral therapy and prolonged exposure therapy treatments Although treatment expectancy, per se, was not measured in this study, prospective treatment expectancy would likely have been high in both study arms, with random assignment expected to distribute this equally between groups. Although expectancy effects are a well-known issue in psychiatric clinical trials and are intertwined with the observation of treatment benefit during a trial 38 , several observations support expectancy mitigation in the current study: 1 the groups did not separate after the first experimental session; 2 placebo with therapy dropouts did not uniformly occur after the first experimental session; and 3 blinding survey data Supplementary Table 6 showed that not all participants correctly identified the treatment that they received. To ensure consistent clinical practice and to mitigate harm, it may be of benefit for prescribers to complete additional training and continuing education if MDMA-AT is approved for use by a regulatory agency. This confirmatory phase 3 trial showed consistent benefits of MDMA-AT in an ethnoracially diverse group of individuals with longstanding moderate to severe PTSD and numerous comorbidities. The dropout rate was low, and treatment was generally well tolerated. These findings represent the culmination of over two decades of research 39 , and, together with MAPP1, indicate that further consideration of this treatment in individuals with moderate to severe PTSD is warranted. Thirteen study sites 11 in the United States and two in Israel, both institutional and private participated. The trial was conducted in accordance with the Good Clinical Practice guidelines of the International Council for Harmonization and with the ethical principles of the Declaration of Helsinki. An independent data monitoring committee ensured that the study was conducted safely and had sufficient sample size. The review boards and institutions that approved the study protocol are listed in the Supplementary Methods. After written informed consent, participants were screened for eligibility. During the Preparation Period that preceded the Treatment Period, participants were tapered off all psychiatric medications before baseline to avoid potential drug interactions and confounding efficacy Supplementary Fig. Full inclusion and exclusion criteria are outlined in the Supplementary Methods. Participants were randomized in a allocation and in a blinded fashion to the MDMA-AT and placebo with therapy groups, stratified by clinical site. A central pool of blinded independent assessors was used to mitigate the risk of functional unblinding Assessors were trained and supervised by independent consultants with expertise in PTSD diagnostics and the CAPS-5 to ensure inter-rater reliability and validity of assessments. The independent assessors were blinded to the general study design, study visit, treatment assignment, number of treatments received and any safety data for the participant. Participants were instructed to withhold their opinion on treatment group assignment and the number of completed visits from the independent assessors. Each assessor conducted no more than one CAPS-5 assessment with each participant to reduce potential bias and expectancy effect from having conducted repeat CAPS-5s with a participant. To ensure that all site and sponsor staff were shielded from study outcomes, the blinded independent assessor pool collected and stored outcome measures in a dedicated database that was separate from the blinded clinical database. A blinding survey was conducted at study termination visit 20 to assess if participants thought that they received MDMA or placebo. Trial procedures were consistent with MAPP1 ref. The supplemental half dose was administered 1. Participants in both treatment groups received identical therapy. This dosing regimen also provides clinicians with the option of dose adjustments if needed. Within the MDMA-AT group, three participants did not undergo dose escalation in experimental sessions 2 and 3, and two participants experienced dose administration timing errors Supplementary Table 2. Each experimental session was followed by three min integration sessions to support participants in processing and understanding their experience Supplementary Fig. Full procedures, including details on therapy teams and training, are outlined in the Supplementary Methods. Exploratory outcome measurements included characterization of the treatment response and differences between the treatment groups by demographics and characteristics. Responder analyses were based on categorical diagnostic assessment data and the CAPS-5 total severity score assessment. Four responder categories were derived and compared at each post-experimental session visit using CAPS-5 scores. TEAEs were defined as any adverse event that occurred during the treatment period from the first experimental session to the last integration session. The severity of TEAEs was determined by the site physician as mild no limitation in normal daily activity , moderate some limitation in normal daily activity or severe unable to perform normal daily activity. A serious TEAE was defined as any unforeseen medical event at any dose of the drug that resulted in death; was life-threatening; required inpatient hospitalization; caused significant disability or incapacity; resulted in a congenital anomaly or birth defect; or required intervention to prevent permanent impairment or damage. Serious TEAEs also included any event, based on medical judgement, that jeopardized the participant or may have required intervention to prevent one of the events listed previously. With the exception of serious adverse event reporting, relatedness to study drug was not assessed by investigators, to preserve blinding. SAS version 9. Fixed effects were treatment, visit, treatment group by visit interaction and dissociative subtype; baseline CAPS-5 score was a covariate. Primary and secondary efficacy analyses used a de jure related to initially randomized treatment estimand and a supportive de facto treatment policy estimand of the modified intention-to-treat population, which required exposure to MDMA or placebo and at least one follow-up CAPS-5 assessment, as in MAPP1 ref. The de jure dataset included all available data, except for 12 one MDMA-AT and 11 placebo with therapy outcome measurements taken after treatment discontinuation in analysis of treatment efficacy Supplementary Table 3. Missed observations were considered missing at random MAR , and choice of this assumption was tested with a tipping point analysis Supplementary Methods. In additional exploratory analyses, 13 covariates were assessed in the model, with alpha set at 0. Analyses of primary or secondary outcomes by gender were not planned a priori; some exploratory analyses included sex as a covariate Supplementary Methods. TEAESIs involving cardiac function that could be indicative of QT prolongation or cardiac arrhythmias were collected, including torsade de pointes, sudden death, ventricular extrasystoles, ventricular tachycardia, ventricular fibrillation and flutter, non-postural syncope and seizures. Further information on research design is available in the Nature Portfolio Reporting Summary linked to this article. However, restrictions apply to the availability of these data, which were used under license for the current study and so are not publicly available. Data are, however, available from the authors upon reasonable request and with the permission of the sponsor. All requests for raw and analyzed data are promptly reviewed to verify if the request is subject to any confidentiality obligations. Participant-related data not included in the paper were generated as part of clinical trials and may be subject to participant confidentiality. Any data that can be shared will be released via a data use agreement. Source data are provided with this paper. Commercially available software SAS version 9. US Department of Veteran Affairs. How common is PTSD in adults? Prevalence of complex post-traumatic stress disorder in refugees and asylum seekers: systematic review. BJPysch Open 7 , e Article Google Scholar. Comorbidity in post-traumatic stress disorder: a population-based study from the two largest cities in Brazil. Hill, S. Dissociative subtype of posttraumatic stress disorder in women in partial and residential levels of psychiatric care. Trauma Dissociation 21 , — Article PubMed Google Scholar. Roberts, N. A systematic review and meta-analysis of psychological interventions for comorbid post-traumatic stress disorder and substance use disorder. Lewis, C. Dropout from psychological therapies for post-traumatic stress disorder PTSD in adults: systematic review and meta-analysis. Steenkamp, M. Psychotherapy for military-related PTSD: a review of randomized clinical trials. JAMA , — Mavranezouli, I. Psychological treatments for post-traumatic stress disorder in adults: a network meta-analysis. Alexander, W. Pharmacotherapy for post-traumatic stress disorder in combat veterans: focus on antidepressants and atypical antipsychotic agents. Google Scholar. Davis, L. The economic burden of posttraumatic stress disorder in the United States from a societal perspective. Psychiatry 83 , 21m Couette, M. Social cognition in post-traumatic stress disorder: a systematic review. Mitchell, J. 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. Nichols, D. Entactogens: how the name for a novel class of psychoactive agents originated. Psychiatry 13 , Mayer, F. Serotonin-releasing agents with reduced off-target effects. Psychiatry 28 , — Sandtner, W. Binding mode selection determines the action of ecstasy homologs at monoamine transporters. MDMA 3,4-methylenedioxymethamphetamine analogues as tools to characterize MDMA-like effects: an approach to understand entactogen pharmacology. Feduccia, A. Psychiatry 84 , — Kamilar-Britt, P. The prosocial effects of 3,4-methylenedioxymethamphetamine MDMA : controlled studies in humans and laboratory animals. Vizeli, P. Effects of 3,4-methylenedioxymethamphetamine on conditioned fear extinction and retention in a crossover study in healthy subjects. Maples-Keller, J. A randomized controlled trial of 3,4-methylenedioxymethamphetamine MDMA and fear extinction retention in healthy adults. Hysek, C. MDMA enhances emotional empathy and prosocial behavior. Brooks Holliday, S. Health 25 , — Goldstein, R. Psychiatry Psychiatr. Zimmerman, M. Psychiatric diagnoses among transgender and gender diverse patients compared to cisgender patients. Herman, J. Complex PTSD: a syndrome in survivors of prolonged and repeated trauma. Trauma Stress 5 , — Schein, J. Prevalence of post-traumatic stress disorder in the United States: a systematic literature review. Med Res. Lewis-Schroeder, N. Conceptualization, assessment, and treatment of traumatic stress in first responders: a review of critical issues. Psychiatry 26 , — Williams, C. Demographic and health behavior factors associated with clinical trial invitation and participation in the United States. JAMA Netw. Open 4 , e Ching, T. MDMA-assisted therapy for posttraumatic stress disorder: a pooled analysis of ethnoracial differences in efficacy and safety from two phase 2 open-label lead-in trials and a phase 3 randomized, blinded placebo-controlled trial. Schnurr, P. Comparison of prolonged exposure vs cognitive processing therapy for treatment of posttraumatic stress disorder among US veterans: a randomized clinical trial. Open 5 , e Jerome, L. Lester, S. Cardiovascular effects of 3,4-methylenedioxymethamphetamine: a double-blind, placebo-controlled trial. Safety pharmacology of acute MDMA administration in healthy subjects. Nicholas, C. Drug Alcohol Depend. Breakthrough for trauma treatment: safety and efficacy of MDMA-assisted psychotherapy compared to paroxetine and sertraline. Psychiatry 10 , Schenberg, E. Who is blind in psychedelic research? Letter to the editor regarding: blinding and expectancy confounds in psychedelic randomized controlled trials. Expert Rev. Doblin, R. Drugs 34 , — Weathers, F. Targum, S. Comparability of blinded remote and site-based assessments of response to adjunctive esketamine or placebo nasal spray in patients with treatment resistant depression. Res , 68—73 Download references. The authors thank all of the participants and their support networks. Medical writing assistance was provided by J. Carpenter and M. You can also search for this author in PubMed Google Scholar. All authors had full access to the trial data, contributed to the interpretation of the data and contributed to writing the manuscript. The authors attest to the accuracy and completeness of the reported data, accept responsibility to submit for publication and confirm that the trial conformed to the protocol and the statistical analysis plan available via Nature Medicine. Correspondence to Jennifer M. Nature Medicine thanks Matthias Liechti, Alimu Dayimu and the other, anonymous, reviewer s for their contribution to the peer review of this work. Primary handling editor: Jerome Staal, in collaboration with the Nature Medicine team. Reprints and permissions. Nat Med 29 , — Download citation. Received : 02 June Accepted : 24 August Published : 14 September Issue Date : October 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. Subjects Drug development Trauma. This article has been updated. Abstract 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. Trauma-focused treatment for comorbid post-traumatic stress and substance use disorder Article 14 November Results Demographics and baseline characteristics Participants were recruited from 21 August to 18 May last participant visit on 2 November Full size image. Table 1 Demographics and clinical characteristics of participants at baseline Full size table. Table 2 Adverse events occurring during treatment Full size table. Participants After written informed consent, participants were screened for eligibility. Randomization and masking Participants were randomized in a allocation and in a blinded fashion to the MDMA-AT and placebo with therapy groups, stratified by clinical site. Statistical analysis SAS version 9. Reporting summary Further information on research design is available in the Nature Portfolio Reporting Summary linked to this article. Code availability Commercially available software SAS version 9. Article Google Scholar Hill, S. Google Scholar Davis, L. Article Google Scholar Schein, J. Article Google Scholar Weathers, F. Acknowledgements The authors thank all of the participants and their support networks. Author information Author notes A list of members and their affiliations appears in the Supplementary Information. Mitchell View author publications. View author publications. Ethics declarations Competing interests J. Peer review Peer review information Nature Medicine thanks Matthias Liechti, Alimu Dayimu and the other, anonymous, reviewer s for their contribution to the peer review of this work. Supplementary information. Reporting Summary. Source data Source Data Fig. Source Data Fig. About this article. Cite this article Mitchell, J. Copy to clipboard. Menkes Trials What should constitute a control condition in psychedelic drug trials? Liechti Neuropsychopharmacology Optimizing real-world benefit and risk of new psychedelic medications: the need for innovative postmarket surveillance Joshua C. Black Andrew A. Monte Richard C. 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Table of contents. While MDMA is currently on the fast track to legalization, only a handful of years ago, few would have imagined that such a thing could be possible. For decades, media coverage suggested the non-classical psychedelic drug most commonly known by the street names ecstasy or molly was the cause of an epidemic of brain damage and seizures amongst young ravers, which created both fear and stigma. As research on MDMA began opening up in the s, more and more clinical trials and studies have made it clear that the compound may offer exciting potential benefits for mental health. In fact, recent neuroimaging studies have demonstrated that MDMA does not appear to cause long-term damage to the serotonin system. Today the growing consensus is that safe, regulated, legal MDMA will reduce harm and may be a valid treatment for conditions such as post-traumatic stress disorder PTSD. It swings open the gate to tactile, emotional, and spiritual exploration and opens the door to the heart. In his article, Dr. Wininger speaks with a married couple who have been exploring the use of MDMA in conjunction with couples therapy to take back control of their relationship. The earliest research into MDMA focused on the ways it could be used to enhance psychotherapy. It showed, and continues to show, promise for the treatment of PTSD, as a tool in couples therapy, and may even have some potential as a treatment for traumatic brain injuries. Around this time, and through the s and early s, it was primarily associated with the rave culture, which adopted the drug due to its capacity to enhance music appreciation and increase feelings of stimulation, intimacy, and euphoria. However, this medicine has now transcended the club scene and entered the realm of mental health treatments once again. However, it can create dramatic shifts in emotional and thought patterns. As Allison A. Feduccia and Michael C. The MDMA experience often helps individuals feel more empathy towards themselves and others, which is why the compound is useful for healing individual distress and interpersonal conflict. Some studies suggest that MDMA-assisted psychotherapy can alleviate the symptoms of several hard-to-treat conditions. These include PTSD, alcohol use disorder colloquially known as alcoholism and substance abuse , eating disorder symptoms, and social anxiety in autistic adults. These effects help patients confront their trauma s , rather than avoid them, and open up more to their therapist. MDMA enhances empathy, trust, and cooperation, which is mediated through the release of serotonin, norepinephrine, and oxytocin. They are also more prone to expressing things they may ordinarily be afraid or embarrassed to discuss. MDMA can also make users feel more connected with the people they love and can increase feelings of intimacy and sensuality. In the context of couples counseling, it may help partners deal with trauma from outside of the relationship that is impacting them. An example would be if one partner had experienced sexual assault before the relationship and is having trouble being intimate as a result. A breakthrough therapy is a drug that can treat a serious or life-threatening condition alone, or in combination with one or more additional drugs. It also means that evidence suggests the medication may demonstrate substantial improvement over existing treatments. The treatment is on track for FDA approval in , at which point patients with the condition not just those enrolled in clinical trials will be able to legally access the treatment. It is important to remember that MDMA is still undergoing clinical trials, and while the results so far are promising, it is still a controlled substance. However, underground MDMA therapy can be found in some places. There are many trustworthy and well-respected therapists, of course, and they may be able to facilitate your MDMA experience in an empathic and beneficial way, but they are not able to do so legally. It is also possible to join a clinical trial, which you find using this database from Psychedelic. By joining one of these trials, you may be able to experience the unique setup of psychedelic therapy and play an important role in helping researchers better understand how the treatment works. But should the compound be decriminalized or legalized in any cities or countries in the future, MDMA therapy retreats may then arise. For example, MDMA and psilocybin were recently legalized in Australia, with rule-making concluding in Once the appropriate regulations are in place, this new legal status could open the door for commercial MDMA retreats and treatment centers. Many of the risks of MDMA are associated with recreational use. People using MDMA in a recreational setting may also take high doses of the drug, redosing frequently during a single session. They may spend hours dancing while dehydrated in a hot, poorly ventilated environment. All these factors, in addition to taking MDMA regularly, may increase the risk of neurotoxicity damage to the brain. Heavy MDMA use may damage serotonin receptors, negatively impacting memory, learning, and mood. However, some research has found that moderate MDMA use is unrelated to neurotoxicity. During MDMA-assisted therapy, medical providers are on hand to monitor your session and provide support if you need it. One study showed that the most common side effects of MDMA include bruxism jaw clenching , sweating, thirst, nausea, accelerated heart rate and breathing, tense muscles, and blurred vision. These MDMA side effects only occur during the treatment. This is not to say that it does not impact users in a spiritual sense. If drugs like LSD and DMT offer mystical experiences pertaining to the nature of reality, the experience derived from MDMA has more to do with the nature of relationships, whether to ourselves or to others. Many users have also anecdotally reported that MDMA inspires a stronger connection to the natural environment or the arts —particularly music. This is why MDMA is so commonly associated with dancing and music. MDMA has a moderate duration of about three-six hours. Particularly if you hope to maximize the therapeutic potential of MDMA. Whether taking MDMA recreationally or therapeutically, there are a few things you can do to prepare yourself before the journey:. That means being in the right place, populated by the right people and things. A few suggestions:. The establishment of set and setting for personal use is relatively straightforward. However, many studies do not seem to cover set and setting in a clinical or trial environment. Such as a comfortable couch or futon, low lights, maybe some flowers, a nearby bathroom, eyeshades, evocative music through headphones or speakers, etc. Many of these align with preparatory actions that one would take if using MDMA for personal use. However, there are some key differences: Whether you plan on participating in a clinical trial, utilizing MDMA recreationally for self-growth, or undergoing MDMA-assisted therapy when it becomes more widely available, reviewing their entire manual may be a good idea. You can find it at MAPS. It is available as a free, downloadable PDF. You may also find it by following the link provided in the works cited. While other psychedelic drugs can deliver unpredictable psychological content accompanied by dramatic emotional shifts throughout their journeys. Most users report that the MDMA experience is fairly consistent. The progression usually goes something like this:. Part of this may be because it can feel somewhat disappointing to return to normalcy when you were feeling so ecstatic, but much of it is due to your body being depleted of its stores of the neurotransmitter serotonin throughout your journey. Lack of sleep, overexertion, and underhydration can all amplify the emotional comedown. You can do a few things to offset the downturn 38 , 39 :. This is the process of analyzing your experience to determine how it can be applied to your everyday life. In a therapeutic setting, some light integration will likely be performed immediately after the journey, though you may feel too drained for deep discussion. This is partially why many psychedelic therapists schedule an integration session for the following day, sometimes with follow-ups a week or even a month afterward. Integration really is the most dynamic work done when using psychedelics for healing purposes. It can yield incredible results, particularly if you keep with it for the days, weeks, and months following a journey. This is the beautiful work of a lifetime in order to create lasting change. Integration comes in many forms, but a few common examples include:. Whatever form integration takes, remember that this is your opportunity to document and later return to the feelings of elation, openness, acceptance, and love that MDMA may open your mind to. This material is not intended as a replacement or substitute for any legal or medical advice. Always consult a medical professional about your health needs. Psychedelics are widely illegal in the United States, and readers should always be informed about local, state, and federal regulations regarding psychedelics or other drugs. Nick Hilden Culture and science writer Nick Hilden has contributed to the Washington Post, Esquire, Popular Science, Scientific American, Rolling Stone, Afar, and many more, and has been an enthusiastic proponent of psychedelics for more than 20 years. Follow Nick on: Twitter, Instagram, Substack. Sam Woolfe ,. David Connell ,. David Connell David Connell is a U. David is also Senior Editor at Supermind. Paloma Lehfeldt, MD, MA, is deeply committed to advancing plant medicine and advocating for the integration of psychedelics into mental health care. Lehfeldt actively engages with academia, medical and scientific associations, local agencies, and community organizations to develop innovative curricula, foster workforce pipelines, and promote initiatives for restorative justice and mental health equity. With over fifteen years of experience in research, community outreach, and education, she brings her expertise to her work with Supermind. Additionally, Paloma volunteers her time to support various nonprofit boards dedicated to empowering women and people of color in the field of plant medicine. March 8, Introduction While MDMA is currently on the fast track to legalization, only a handful of years ago, few would have imagined that such a thing could be possible. Educate Yourself. Read about the experience and talk about it with others who have tried MDMA. This will better equip you to navigate the experience. Set an Intention. Spend some time pondering your goals in relation to the journey and what you hope to take away from it. Journaling can help. Certainly, you will want to consider this in a therapeutic setting. Prepare Your Body. MDMA can be physically demanding, particularly if you plan on dancing or if you will be participating in therapy via a clinical trial. Prepare your body by eating a healthy diet for a few days before your trip. While others prefer to eat beforehand to avoid getting hungry during the experience. Consider which is best for your body. If you do decide to eat beforehand, make it a light meal. During the experience, drink plenty of water to avoid dehydration. Prepare Your Mental State. While you may be seeking a psychedelic experience to address a mental health issue, it is never advisable to enter the journey while you are experiencing distressing symptoms. Calm your mind as much as possible in the hours leading up to taking MDMA. Many find that meditation and yoga help. It is often enjoyable to access both indoor and outdoor spaces. MDMA is famous for its ability to increase physical intimacy, sexual arousal, and libido. Be aware of noise levels. Cranking up the music to dance is a fine idea, but be mindful of neighbors and those around you, both for your sake and theirs. Keep plenty of water on hand. The most common risks associated with MDMA are overheating and dehydration. The Importance of Social Support. MAPS emphasizes that you should ensure that you have a supportive social group. They recommend asking a friend, partner, family member, or other loved one to spend time with you at the end of an MDMA-assisted therapy session. This should be cleared with your therapist to help your loved one understand the emotional support you may need and determine what is appropriate after the session. Music as a Tool for Therapy. Researchers and medical practitioners employed with MAPS place great importance on using music as a therapy tool. They create carefully curated playlists that are designed to help their patients relax and maximize the impact of MDMA. The music provided is paired with eye shades and headphones. This is intended to help you relax and enjoy the experience as much as possible. MDMA therapists are expected to be empathetic guides throughout the process and to assist patients with remaining present during the experience. They are there to help guide you while you process any trauma or difficult memories that will likely arise during your session. You ingest the MDMA, and nothing happens for about minutes. This sensation is subtle at first but increases steadily. You may feel warm and begin to sweat. Typically, the MDMA high will peak and plateau within one to two hours. During this period, most people report that they feel absolutely wonderful. This is when the most rewarding work is done in a therapeutic setting. During this period, you may experience strong visual distortions such as persistent light tracers and powerfully illuminated colors. Talk with a therapist or friend about it sometimes all it takes is discussing these negative feelings to alleviate them, especially if laughter is involved Meditate or perform yoga to calm your mind and body Drink plenty of water and eat something light fruit is ideal Go for a walk Sleep Talking with a trained therapist. Journaling or writing a letter to yourself or someone else. Creating art. Meditating or performing yoga. Initiating a daily gratitude practice. Grounding the lessons each day. Sources Gamma, A. Neuropsychopharmacology, 23 , — Clinical Trials Arena. Rolling Stone. The origin of MDMA ecstasy revisited: the true story reconstructed from the original documents. Addiction , 9 , — Drug Science, Policy and Law , 4 , The Guardian. Progress in Neuro-Psychopharmacology and Biological Psychiatry , 84 , — Nature News. First study of safety and tolerability of 3,4-methylenedioxymethamphetamine-assisted psychotherapy in patients with alcohol use disorder. Journal of Psychopharmacology , 35 4 , — MDMA-assisted therapy significantly reduces eating disorder symptoms in a randomized placebo-controlled trial of adults with severe PTSD. 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