Furthermore, the properties of MDMA that made it an effective aid to psychotherapy also led to its widespread use in social situations. During this period of time, recreational use of MDMA increased dramatically, and mounting evidence suggested that MDA, a structurally related compound, was neurotoxic. In this confirmatory phase 3 study of participants with moderate to severe PTSD, MDMA-AT significantly improved PTSD symptoms and functional impairment, as assessed by CAPS-5 and SDS, respectively, compared to placebo with therapy over 18 weeks.
Fluid Restriction May Prevent MDMA-Related Hyponatremia
Across six Phase 2 trials (105 participants) following MDMA-assisted psychotherapy, 54% of participants did not meet the criteria for PTSD, compared to 23% in the control group. Most participants also reported other benefits, including improved relationships and well-being, better sleep quality, and post-traumatic growth. While many modern clinical trials occur within clinics or research institutes, the session rooms are made to appear as comfortable living rooms. The comfortable living room setting must be private and free of interruption. The room should be decorated with pleasing artwork and/or flowers, providing an aesthetically pleasing ambiance. Any negative or powerful images should be avoided.The comfort provided will likely be a futon, couch, or similar that is off the floor and enables the participant to either lie down or sit up with pillow support.
Side-effects of mdma-assisted psychotherapy: a systematic review and meta-analysis
As a double-blind placebo-controlled study, it has a low risk for bias, allowing for valuable data collection. Just under 27% of participants were Hispanic or Latino, and about 34% identified as non-white. MDMA-AT includes 6-8-hour MDMA sessions, preparatory sessions and integrative sessions in the days before and after the MDMA sessions, and additional weekly therapy sessions, which total to about twelve 90-minute sessions. While P-AT protocols differ in some ways, administration sessions last an average of 7.46 hours and include at least one preparation and typically about 6 integration sessions (59).
- For Phase 2 studies, all primary outcomes were rated as having very low certainty of evidence.
- There were some side effects and adverse events that participants experienced.
- Finally, we discuss its history and why it is perhaps the most important compound for the future of psychedelic science—having the potential to either facilitate new psychedelic research initiatives, or to usher in a second Dark Age for the field.
Study design and oversight
Her Center for Psychedelic Psychotherapy and Trauma Research uses clinical trials, computational genetics, molecular biology, blood samples, and neuroimaging to accelerate understanding of how MDMA and psilocybin work. The center also holds clinical trainings for therapists in anticipation of FDA approval and leads public and scientific education, including a monthly lecture series. Symptomology was measured over the course of 18 weeks using the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5), which ranges from 0 (no symptoms) to 80 (most severe symptoms possible). At the end of the 18-week study, the mean CAPS-5 score for the placebo group had fallen by 14.8, while the mean score for the MDMA group had fallen by 23.7. Moreover, 45 of 52 (86.5 percent) within the MDMA group achieved a clinically meaningful benefit, as defined in this study by a 10-point decline in CAPS-5 score. As noted above, 37 (71.2 percent) participants from the MDMA group no longer met criteria for PTSD.
PTSD: National Center for PTSD
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-19 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). molly mdma The primary outcome analysis was replicated independently by one blinded programmer and one unblinded programmer. The substituted amphetamine 3,4-methylenedioxymethamphetamine (MDMA) induces serotonin release by binding primarily to presynaptic serotonin transporters12.
- Schedule I status has severely hampered access to psychedelics for research purposes.
- In Phase 2 studies, the odds of experiencing any side effect in the 7 days following medication sessions were higher in the MDMA-AP group compared with controls.
- These transient elevations did not require clinical intervention, including among the subset of participants with well-controlled hypertension.
- Founded in 1986 by Rick Doblin, MAPS’ decades of hard work to realize MDMA’s psychotherapeutic potential is finally paying off in enormous ways.
- Here’s a sampling of the most impactful findings from MDMA-assisted psychotherapy clinical trials.
- In typical protocols, patients attend 3–4 initial ‘preparatory’ psychotherapy sessions, followed by 2–3 full day MDMA- (or placebo-) assisted sessions, each followed by 3–4 ‘integration’ psychotherapy sessions.
- For an excellent and detailed account of the origins of MDMA in the U.S. and psychotherapy, please read this timeline.