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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. The success of modern medicine creates a growing population of those suffering from life-threatening illnesses LTI who often experience anxiety, depression, and existential distress. Overall, MDMA was well-tolerated in this sample. These preliminary findings can inform development of larger clinical trials to further examine MDMA-assisted psychotherapy as a novel approach to treat individuals with LTI-related anxiety. Trial Registration : clinicaltrials. Individuals facing, or who have faced, a life-threatening illness LTI , contend with more than just the physical symptoms of their condition. Anxiety, depression, anger, and despair often exacerbate the distress already caused by the illness itself, even after a remission or cure is achieved 1. It is common for survivors to harbor fears of potential relapse, recurrence, and death 2. Additionally, the impact of LTIs on family, health care providers, and community can be profound and affect recovery. A significant increase in caregiver distress is also prevalent 1 , 5. There is a great need for new treatment options to address the psychological distress associated with LTIs. The social and personal burden of the immense numbers of people surviving LTIs necessitates our full attention and care. Early investigations with psychedelic compounds such as lysergic acid diethylamide LSD suggested that psychoactive substances held promise in addressing distress, pain, and anxiety in people with LTIs 6 , 7. Findings from studies reported from to 8 , 9 , 10 , 11 , 12 provide evidence for the use of psychedelics, specifically psilocybin and lysergic acid diethylamide LSD , as an efficacious modality for the treatment of depression, anxiety, and psycho-existential distress among those with LTIs, including the terminally ill 13 , Randomized, placebo-controlled trials reported reduction in symptoms of anxiety and depression compared with controls, with some indication that symptom reduction might be linked to subjective drug effects, such as strength of a mystical experience Manualized 3,4-methylenedioxymethamphetamine MDMA -assisted psychotherapy shares a number of similarities with methods used in psychedelic-assisted psychotherapy. MDMA is under investigation as an adjunct to psychotherapy for various anxiety-related conditions. In the Phase 2 trials, participants who were given active-dose MDMA 75— mg and psychotherapy experienced significantly greater reductions in PTSD symptoms when compared with participants given inactive placebo or low-dose MDMA 0—40 mg 17 , 18 , 19 , 20 , MDMA-assisted psychotherapy also reduced symptoms of depression and improved sleep quality. MDMA stimulates release of monoamines serotonin, dopamine, and norepinephrine , elevates levels of the neurohormone oxytocin, reduces amygdala and right insular activity in response to negative emotional stimuli, increases superior frontal cortex activity, and increases connectivity between the amygdala and hippocampus 23 , 24 , 25 , In such studies, functional magnetic resonance imaging fMRI technique, blood oxygen level dependent imaging, or BOLD-contrast imaging, was used to assess neuronal activity in these regions. The effects of MDMA may reduce anxiety in the face of emotionally challenging thoughts or memories and can increase self-compassion and enhance fear-extinction learning 27 , 28 , 29 , PTSD or PTSD-like symptoms are often reported after a cancer diagnosis, myocardial infarction, or stroke 31 , 32 , 33 ; and several participants in previous study of MDMA-assisted psychotherapy have reported an LTI or a medical treatment to be comparable to an index trauma The aim of this pilot study was to examine the safety and efficacy of MDMA-assisted psychotherapy, among patients with cancer or non-dementing neurological diseases, to alleviate anxiety and other psychiatric symptoms, including depression and poor sleep quality, related to an LTI. There preliminary results will serve to inform development of larger clinical trials. Ninety-two of participants who were initially screened failed to meet the inclusion criteria at telephone screening. The primary reasons for exclusion included not living in the study area and not being physically well enough, due to having a life-threatening illness, that prevented study participation. A few were lost to follow-up and three participants were excluded after enrollment and prior to randomization because they did not meet the study enrollment criteria Fig. Table 1 compares baseline characteristics between treatment groups. The overall sample had a mean SD age of All participants had a prior diagnosis of an LTI. For the primary diagnosis for study inclusion, Medical histories indicated that many of the participants were previously diagnosed with anxiety Seven of 18 participants Six discontinued opiate medications at least three days prior to and two days after a blinded or unblinded MDMA session. One full-dose group participant reported taking a medication containing tramadol, an opiate with some serotonergic activity, during the course of the study but did not take the medication before, during, or within 24 h after an experimental session. The primary outcome was change in STAI-Trait anxiety scores 35 from baseline to one-month post second blinded experimental session Table 2 , Fig. Future studies with a larger sample size are needed to account for such outliers and elucidate these findings. Mean SD State Trait Anxiety Inventory scores across time at baseline, primary endpoint one-month post second blinded experimental session , end of stage 1 one month post third MDMA session, i. The grey box represents the open-label crossover after placebo group was unblinded at the primary endpoint. Groups were collapsed for long-term follow-ups since all participants had received active doses of MDMA in either the blinded or open-label stage. Secondary outcomes showed that the MDMA group significantly benefited vs. Results on the STAI-State anxiety, depression, sleep quality, and global functioning 39 , 40 , 41 , 42 , 43 , 44 followed the same trajectory indicating greater improvement in the MDMA group vs. After the open-label sessions, for both the MDMA and the placebo crossover groups, change scores improved across symptom domains eTable 5. Table 3 presents change in outcome scores at baseline, treatment exit after the last experimental session in stage 1 for the MDMA group and stage 2 for the placebo group , 6-month follow-up, and month follow-up. After the crossover, by the end of the study, all participants had received similar treatment doses with three MDMA-assisted psychotherapy sessions. Therefore, groups were combined for one-way repeated measures ANOVA across time points, separately, for each outcome. MDMA was well-tolerated. The optional supplemental dose was taken in all but one session. In the seven days following MDMA administration, the most frequently reported reactions were fatigue, needing more sleep, insomnia, and low mood, and these reactions decreased over the course of the week. One participant discontinued treatment after the primary endpoint as a result of re-occurring cancer unrelated to MDMA and died approximately a year later. This participant experienced a series of five Serious Adverse Events SAEs that were associated with cancer recurrence and medical interventions, and included chordoma, spinal cord paralysis, meningitis, sepsis, and cerebrovascular accident. In addition, two other participants reported two SAEs related to cancer progression during the follow-up period. Placebo Elevations in vital signs did not require any medical intervention and approached pre-drug values by session end. According to the C-SSRS, there were no reports of serious suicidal ideation or positive suicidal behavior during the study. At the end of each blinded session, participants and co-therapy team members were asked to guess if MDMA or placebo was administered in the session. The investigators guessed correctly 32 of 36 Investigators guessed incorrectly for two participants, one assigned to placebo and one assigned to MDMA. Similarly, participants guessed correctly 31 of 36 There were three participants who guessed incorrectly. In 2 of 3 of these, the participant guessed MDMA when in fact they had received placebo. The present study examined MDMA-assisted psychotherapy for individuals with moderate to severe anxiety associated with life-threatening illnesses. Additionally, 2 of 5 placebo participants believed they were in the MDMA group which might have produced a placebo effect. Results from the blinded portion of the study warrant larger clinical trials to examine MDMA-assisted psychotherapy as a novel approach to treat individuals who suffer from LTI-related anxiety. Data from these trials can also elucidate the relationship between outcome measures including identification of potential covariates that may mediate or moderate the primary outcome results. There were limitations in the long-term follow-up results, specifically, lack of a control group to eliminate the role of other factors in long-term benefits. However, at the 6- and month follow-up visits, these outcomes were stable and above baseline levels, which suggests the potential for MDMA-assisted psychotherapy to produce long-term benefits of up to one or more years. These results were consistent with findings from a study on psilocybin-assisted psychotherapy, which reported people with LTIs had changes in death-related attitudes 9. These preliminary findings suggest that MDMA-assisted psychotherapy might have the potential to provide long-term benefits for people who have or are overcoming a serious illness. Further research is also needed to examine possible mechanisms of MDMA-assisted psychotherapy including the role of potential mediators and moderators in reducing LTI-related anxiety. There are several possible explanations for the effects of MDMA-assisted psychotherapy on anxiety and other symptoms. Previous studies have reported that PTSD can occur among people with chronic illnesses undergoing treatment, and that PTSD symptoms even persist long after remission 2 , 31 , 45 , In the current sample with an LTI, a large number of participants Although the index trauma for the PTSD diagnoses was not collected, it is likely that traumas and complex emotions were addressed through similar neural mechanisms and therapeutic processing. The effects of MDMA allow for empathic intervention of executive functions toward oneself and others 23 , 49 , Reduction in right insular activity may reduce anxiety through reducing attention and concern over the bodily experience of anxiety MDMA-induced changes in connectivity appear to be restricted to specific regions in the salience network, and not affecting connectivity globally. Other neurochemical and behavioral effects of MDMA include increased oxytocin 51 , elevated serotonergic activity 52 , increased self-compassion, and prosocial interactions with others 24 , 28 , which can enhance trust and rapport with therapists. MDMA-assisted psychotherapy has demonstrated sustained reductions in PTSD symptoms in individuals who had failed to respond adequately to existing pharmacologic or psychotherapeutic treatments 17 , 18 , 19 , 20 , 21 , Compared to the placebo group in the blinded segment of the present study, the MDMA group trended toward reduced psychiatric symptoms, such as anxiety, depression and self-reported impaired sleep quality, associated with LTIs. While under the effects of MDMA, acute alterations in brain circuits important for in memory and emotional processing could have allowed participants to approach emotionally painful memories or thoughts with empathy and compassion rather than feeling overwhelmed by anxiety 28 , The durability of improvement several months after MDMA-assisted psychotherapy sessions demonstrates benefits might extend beyond the acute treatment effects. Reactions were short in duration and mostly subsided by the end of an experimental session, or during the week following. Psychiatric adverse events were infrequent, and MDMA was not associated with serious suicidal ideation or behavior. Overall, the safety profile for MDMA in this controlled clinical setting indicated that MDMA-assisted psychotherapy was a safe treatment in this relatively small sample where the benefits outweighed the cost of mild and short-term reactions. Future studies should continue to evaluate risks of adverse events in a larger sample of individuals with life-threatening illnesses. Study limitations included the study design and small sample. This pilot study was exploratory and not powered to detect statistical significance. Additionally, the degree of group differences was impacted by an outlier in the placebo group who responded exceptionally well to psychotherapy alone compared to other participants in the placebo group during the blinded segment. This could have been influenced by a potential placebo effect, since 2 of 3 placebo participants believed they were assigned MDMA during the blinded sessions. In this relatively small study sample, this outlier might explain the lack of statistical significance in the between-group differences in primary outcome change scores, although a larger study would be needed to elucidate these findings. After all participants received three MDMA sessions, results indicated significant improvements in outcomes at treatment exit, 6-month and month endpoints. However, the interpretation of these results was limited due to lack of a control group after crossover. These findings provide preliminary evidence to support that MDMA-assisted psychotherapy may be a safe and feasible treatment for those with LTIs for anxiety reduction and relief of other psychiatric symptoms associated with their illness. Study results support the feasibility of MDMA-assisted psychotherapy as a novel approach for potential long-term treatment of LTI-related anxiety. These findings will inform development of future clinical trials with larger sample size and among more diverse populations. The present study was a Phase 2 clinical trial that tested the safety and efficacy of MDMA-assisted psychotherapy using a double-blinded, randomized, placebo-controlled design with an open-label crossover. The design consisted of a blinded segment that included two day-long experimental sessions MDMA or placebo scheduled two to four weeks apart, along with nine to min non-drug psychotherapy sessions; three preparing participants for the first experimental session and three for integration after each experimental session. Primary outcome measures were administered approximately one month after the second experimental session, and then the blind was broken. The design included a crossover segment where participants in the MDMA group had one additional open-label MDMA session and the placebo group participants had three open-label sessions with MDMA, with associated integrative sessions. The dose used in all MDMA sessions was mg followed by an optional supplemental dose of The study protocol was approved by Western Copernicus Group Institutional Review Board and conducted in accordance with the ethical standards laid down in the Declaration of Helsinki. Participants were recruited through referrals from healthcare professionals, word-of-mouth, and internet advertisements. Eligible participants were men and women, aged 18 years or older, who were diagnosed with a life-threatening cancer or non-dementing neurological illness that was ongoing or in remission with risk of recurrence and had an estimated life expectancy of at least nine months. Medical history information was collected through participant report and review of medical records. Study exclusions were ongoing primary treatment for their illness, such as initial chemotherapy for cancer, major medical conditions contraindicated for MDMA administration, uncontrolled hypertension, history of significant cerebrovascular or cardiovascular disease, primary or metastatic tumors in the brain, renal disease, dementing neurological disease, diabetes type I or II, history of hyponatremia or hyperthermia, weight less than 48 kg, pregnancy or lactation , diagnosis of psychotic disorders, bipolar disorder I, dissociative identity disorder, or eating disorder with active purging. Participants were excluded if they could not safely taper off psychiatric medications, which was required for study participation. Participants were permitted to take prescribed opiate medications. Enrollment was allowed for participants with substance use disorders, if in remission for at least 60 days prior to enrollment. All participants provided written informed consent prior to enrollment in the study. Participants who gave written informed consent were screened for study eligibility and examined for non-psychiatric conditions by a physician. Participants were randomized to receive either inactive placebo mg lactose or mg MDMA in an approximate ratio using a web-based randomization system with unique container numbers. Randomization was maintained by individuals who monitored the randomization process without communicating with site staff, individuals monitoring the study, or data and statistical analysts. MDMA was manufactured by Dr. A pharmacist compounded MDMA or lactose placebo into gelatin capsules to ensure all blinded capsules were similar in appearance and weight. The blind was broken for each participant after completion of all study assessments at the primary endpoint, which occurred approximately one month after the second blinded session. At enrollment, before blinded sessions, participants prepared for experimental sessions with a male and female co-therapy team in three 60 to min non-drug sessions. During these preparatory sessions, participants discussed feelings and life issues related to their diagnosis with an LTI, any questions or concerns associated with taking MDMA, including general hopes and fears, and any specific goals for their upcoming treatment. The therapists provided information about what to expect during blinded sessions. Participants completed several secondary outcome measures during preparatory sessions. There were four therapists organized into three co-therapy teams. Each participant saw the same co-therapy team for all visits. After the third preparatory session, the first of two blinded experimental sessions occurred within five weeks of study enrollment. Experimental sessions occurred at two- to four-week intervals. Sessions were held in a comfortable, aesthetically pleasing living room, with an adjoining room where the participant would stay overnight. After pregnancy and drug screens were performed, each participant received either mg of MDMA or the placebo during each experimental session, and an optional supplementary dose of During each session, participants were provided with eyeshades and could listen to music through headphones to support reflecting on internal thoughts and emotions, as described in the Treatment Manual The therapists verbally checked in with participants at intervals during the session. If participants did not speak for an hour or appeared to be avoiding discussion of emotions or thoughts, the therapists reminded the participants about the session goals, and about addressing their LTI related anxiety and feelings. Physiological measures blood pressure, heart rate, and temperature were assessed every half hour for the first four hours, and hourly for the remainder of the experimental session. More frequent measurements were taken if any of these vital signs rose above pre-determined cut-off values. Participants remained at the study site overnight with a night attendant. Guesses were recorded to assess potential biases that might have been introduced due to perceived group assignments inducing a placebo effect. For example, a placebo participant who believes they might have received active MDMA might be more inclined to report positive effects, and vice versa, although blinding might also be less effective among active MDMA group participants due to the nature of the effects. The day following an experimental session, participants met with the therapy team for an integrative non-drug therapy session. One of the therapists contacted the participant by telephone for seven consecutive days after each experimental session to assess general well-being, and to record common, expected reactions and adverse events. Participants and the therapist team met for two integrative sessions during the month following, during which the participant continued to process material from experimental sessions. The blind was broken at this point; participants randomized to MDMA received a third open-label MDMA psychotherapy session, and participants randomized to placebo crossed over into an open-label study arm stage 2. The crossover consisted of three open-label sessions of mg MDMA combined with associated non-drug psychotherapy sessions. Anxiety, depression and other symptoms were assessed one month after the second open-label MDMA experimental session secondary endpoint and one month after the third MDMA session end of stage 2. See Fig. All participants were re-assessed six and 12 months after their final experimental session with outcome measures administered at each follow-up visit 6-Month and Month Follow-ups, Fig. The STAI is a well-established and stable measure of cross-situational trait and current mood state anxiety The primary outcome measure of anxiety was change in the STAI-Trait subscale scores from baseline to primary endpoint. STAI-State anxiety scale total scores served as a secondary measure of anxiety. This self-reported measure is a item questionnaire, which has been used in healthy populations as well as people with anxiety disorders. Adverse events were collected throughout the study, except for events related to planned medical procedures or physician visits related to a medical diagnosis at baseline. Spontaneous reports of common expected events were collected during experimental sessions and for seven consecutive days following. The Columbia Suicide Severity Rating Scale C-SSRS 59 was used to monitor suicidal ideation and behavior and administered during every in-person visit and on the second and seventh phone contact days. This was a feasibility study and therefore was not powered to detect statistical significance. The study design and sample size were based on Phase 2 studies of MDMA-assisted psychotherapy for PTSD treatment 18 , 19 , 20 ; there was no prior MDMA research relevant to this population, or primary outcome measure to serve as a basis for power analysis. An intent-to-treat ITT analysis was conducted for safety and efficacy measures, which included all participants at a given time point. All analyses were set at an alpha level of 0. The Folded F test was used to test equality of variances. Pooled t tests were reported for equal variances and Satterthwaite t tests for unequal variances. The primary outcome analysis used an independent-samples t test to compare changes in STAI-Trait scores for measure of anxiety from baseline to one month after the second blinded experimental session primary endpoint across treatment groups. Analyses of secondary measures used the same approach. Descriptive statistics were used to compare baseline characteristics and demographics. Due to the small number of participants in the open-label crossover, treatment groups from each stage were combined since all participants had full dose MDMA in stage 1 or stage 2 for a pooled data set. Descriptive statistics of the open-label sessions are provided in the supplemental content including adverse events and outcome scores. Across the two blinded sessions, average peak vital signs max recorded values during session post-drug were compared between groups with t tests. Analyses were done using SAS, version 9. Grunfeld, E. Family caregiver burden: results of a longitudinal study of breast cancer patients and their principal caregivers. CMAJ , — Jacobsen, P. Posttraumatic stress disorder symptoms after bone marrow transplantation for breast cancer. Grassi, L. Psychosocial needs and well-being issues of long-term survivors and cured cancer patients. PubMed Google Scholar. Iconomou, G. Emotional distress in cancer patients at the beginning of chemotherapy and its relation to quality of life. BUON 13 , — Wolfson, P. North Atlantic Books, Kast, E. Study of lysergic acid diethylamide as an analgesic agent. Kurland, A. Gasser, P. Safety and efficacy of lysergic acid diethylamide-assisted psychotherapy for anxiety associated with life-threatening diseases. Griffiths, R. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: a randomized double-blind trial. Grob, C. In Psychological Aspects of Cancer — Springer, Ross, S. Rapid and sustained symptom reduction following psilocybin treatment for anxiety and depression in patients with life-threatening cancer: a randomized controlled trial. Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer. Psychiatry 68 , 71— Blinderman, C. Article PubMed Google Scholar. Mithoefer, M. Novel psychopharmacological therapies for psychiatric disorders: psilocybin and MDMA. The lancet. Mystical-type experiences occasioned by psilocybin mediate the attribution of personal meaning and spiritual significance 14 months later. Feduccia, A. Progress and promise for the MDMA drug development program. Psychopharmacology , — Lancet Psychiatry 5 , — Durability of improvement in post-traumatic stress disorder symptoms and absence of harmful effects or drug dependency after 3,4-methylenedioxymethamphetamine-assisted psychotherapy: a prospective long-term follow-up study. Oehen, P. Danforth, A. Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Carhart-Harris, R. The effects of acutely administered 3,4-methylenedioxymethamphetamine on spontaneous brain function in healthy volunteers measured with arterial spin labeling and blood oxygen level-dependent resting state functional connectivity. Psychiatry 78 , — Kamilar-Britt, P. The prosocial effects of 3,4-methylenedioxymethamphetamine MDMA : controlled studies in humans and laboratory animals. Walpola, I. Altered insula connectivity under MDMA. Neuropsychopharmacology 42 , — Bedi, G. Effects of MDMA on sociability and neural response to social threat and social reward. Psychopharmacology , 73— Psychiatry 84 , — Kamboj, S. Additive effects of 3,4-methylenedioxymethamphetamine MDMA and compassionate imagery on self-compassion in recreational users of ecstasy. Mindfulness N Y 9 , — Article Google Scholar. Young, M. Psychiatry 5 , e Inhibition of serotonin transporters disrupts the enhancement of fear memory extinction by 3,4-methylenedioxymethamphetamine MDMA. Allen, J. Posttraumatic stress-related psychological functioning in adult survivors of childhood cancer. Cancer Surviv. Goldfinger, J. Correlates of post-traumatic stress disorder in stroke survivors. Stroke Cerebrovasc. Oflaz, S. Does illness perception predict posttraumatic stress disorder in patients with myocardial infarction?. Noro Psikiyatr Ars 51 , — First, M. Spielberger, C. Manual for the State-Trait Anxiety Inventory. Consulting Psychologists Press, Tedeschi, R. The posttraumatic growth inventory: measuring the positive legacy of trauma. Stress 9 , — Baer, R. Using self-report assessment methods to explore facets of mindfulness. Assessment 13 , 27— Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment 15 , — Beck, A. Internal consistencies of the original and revised beck depression inventory. Comparison of beck depression inventories -IA and -II in psychiatric outpatients. Buysse, D. The Pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. Cella, D. Combining anchor and distribution-based methods to derive minimal clinically important differences on the Functional Assessment of Cancer Therapy FACT anemia and fatigue scales. Pain Symptom Manag. Measuring quality of life in chronic illness: the functional assessment of chronic illness therapy measurement system. Montgomery, S. A new depression scale designed to be sensitive to change. Psychiatry , — Andrykowski, M. Cordova, M. Frequency and correlates of posttraumatic-stress-disorder-like symptoms after treatment for breast cancer. Greer, G. Subjective reports of the effects of MDMA in a clinical setting. Psychoactive Drugs 18 , — Hysek, C. MDMA enhances emotional empathy and prosocial behavior. Affect Neurosci. Dumont, G. Increased oxytocin concentrations and prosocial feelings in humans after ecstasy 3,4-methylenedioxymethamphetamine administration. 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. Vizeli, P. Safety pharmacology of acute MDMA administration in healthy subjects. Kolokotroni, P. Psychosocial factors related to posttraumatic growth in breast cancer survivors: a review. Women Health 54 , — Gesser, G. Omega Westport 18 , — — Neff, K. The Development and validation of a scale to measure self-compassion. Self Identity 2 , — Posner, K. Download references. Deep appreciation to the family members and loved ones who inspired, encouraged, and supported this study. MAPS and MAPS PBC assisted with study design; monitoring of study data; analysis, management and interpretation of data; preparation, review, and approval of manuscript; and decision to submit the manuscript for publication. The funder had no role in the collection of data or conduct of the study. Allison A. Feduccia, Lisa Jerome, Julie B. Wang, Shannon C. You can also search for this author in PubMed Google Scholar. Study concept and design: P. Acquisition, analysis, or interpretation of data: P. Drafting of the manuscript: A. Critical revision of the manuscript for important intellectual content: P. Obtained funding: R. Study supervision: P. Correspondence to Julie B. Michael Mithoefer received compensation for his work as medical monitor. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. Reprints and permissions. MDMA-assisted psychotherapy for treatment of anxiety and other psychological distress related to life-threatening illnesses: a randomized pilot study. Sci Rep 10 , Download citation. Received : 12 December Accepted : 14 October Published : 24 November 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: Translational Research newsletter — top stories in biotechnology, drug discovery and pharma. Skip to main content Thank you for visiting nature. Download PDF. Subjects Drug discovery Medical research. Abstract The success of modern medicine creates a growing population of those suffering from life-threatening illnesses LTI who often experience anxiety, depression, and existential distress. A systematic review and meta-analysis of acceptance- and mindfulness-based interventions for DSM-5 anxiety disorders Article Open access 14 October Depression, anxiety, and personal recovery outcomes after group vs individual transdiagnostic therapy: a brief report Article Open access 28 February Cluster-based psychological phenotyping and differences in anxiety treatment outcomes Article Open access 21 February Introduction Individuals facing, or who have faced, a life-threatening illness LTI , contend with more than just the physical symptoms of their condition. Figure 1. Full size image. Table 1 Demographics and baseline characteristics. Full size table. Table 2 Outcome measures a at baseline and post two blinded experimental sessions. Figure 2 Mean SD State Trait Anxiety Inventory scores across time at baseline, primary endpoint one-month post second blinded experimental session , end of stage 1 one month post third MDMA session, i. Table 3 Outcome measures a at baseline, treatment exit b , 6-month follow-up, and month follow-up—within-subject. Discussion The present study examined MDMA-assisted psychotherapy for individuals with moderate to severe anxiety associated with life-threatening illnesses. Conclusions These findings provide preliminary evidence to support that MDMA-assisted psychotherapy may be a safe and feasible treatment for those with LTIs for anxiety reduction and relief of other psychiatric symptoms associated with their illness. Methods Study design and participants The present study was a Phase 2 clinical trial that tested the safety and efficacy of MDMA-assisted psychotherapy using a double-blinded, randomized, placebo-controlled design with an open-label crossover. Randomization and masking Participants were randomized to receive either inactive placebo mg lactose or mg MDMA in an approximate ratio using a web-based randomization system with unique container numbers. Procedures At enrollment, before blinded sessions, participants prepared for experimental sessions with a male and female co-therapy team in three 60 to min non-drug sessions. Figure 3. Study design. References Grunfeld, E. Article Google Scholar Young, M. Article Google Scholar Cella, D. Article Google Scholar Posner, K. Mithoefer Authors Philip E. Wolfson View author publications. View author publications. Additional information Publisher's note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Supplementary information. Supplementary Information. About this article. Cite this article Wolfson, P. Copy to clipboard. Menkes Trials Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis Julia Colcott Alexandre A. Baldo Archives of Toxicology In the new era of psychedelic assisted therapy: A systematic review of study methodology in randomized controlled trials Paul S. Soliman Dallece E. Curley Carolina L. Haass-Koffler Psychopharmacology Publish with us For authors Language editing services Submit manuscript. Search Search articles by subject, keyword or author. Show results from All journals This journal. Advanced search. Close banner Close. Email address Sign up. Get what matters in translational research, free to your inbox weekly. Sign up for Nature Briefing: Translational Research.

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