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. 2021 Jun 1;51(3):125–149.

Table 3. Safety.

Study type Author (Year) Safety Measures Results Conclusions
Randomized, double blinded control trial Bouso, José Carlos; Doblin, Rick; Farré, Magí; et al (2008).86 Heart rate, blood pressure, Hallucinogen Rating Scale and the UKU Scale of Secondary Effects, side effects MDMA groups reported mild 24-hour symptoms such as sleepiness, tension, palpitations, headache, and increased fatigability. No remarkable changes occurred in heart rate or blood pressure during the experimental session Due to the small subject size and no statistical analysis, there are limited conclusions that can be drawn from the study.
Randomized, double blinded control trial Mithoefer, Michael C.; Wagner, Mark T.; Mithoefer, Ann T.; et al (2011).87 Blood pressure, heart rate, temperature, side effects Experimental group had a greater rise in blood pressure, heart rate, and temperature than the placebo group. Both groups vitals restored to baseline shortly after session. MDMA group more frequently experienced dizziness, jaw tightness, loss of appetite, coldness, nausea and impaired balance. Anxiety, irritability, and loss of appetite were endorsed more frequently in the MDMA group but also experienced in the placebo group. MDMA will likely alter vital signs during sessions but should return to baseline after administration. MDMA may cause patients symptoms but majority are self-limiting.
Randomized, double blinded control trial Oehen, Peter; Traber, Rafael; Widmer, Verena; et al (2013).89 Blood pressure, heart rate, temperature, side effects Blood pressure and heart rate for the experimental group barely missed statistical significance when compared to placebo. Common side effects in both groups were insomnia and loss of appetite; while the experimental group reported restlessness, jaw tightness, thirst, and coldness almost exclusively. No adverse events. MDMA has the potential to be administered safely without major adverse events. When considering this study with prior ones, jaw tightness and coldness seem to be recurring symptoms for only the MDMA group.
Randomized, double blinded control trial Ot’alaora G, Marcela; Grigsby, Jim; Poulter, Bruce; et al (2018).35 Heart rate, blood pressure, and temperature, treatment emergent adverse events Increase in heart rate and systolic blood pressure reached significance and near significance, respectively. Treatment emergent adverse events were more common in the experimental groups, and psychiatric symptoms included anxiety, depressed mood, and irritability. Changes in most vital signs due to MDMA can be significant but return to baseline. Psychiatric symptoms are possibly more common in subjects who receive MDMA.