Three Things To Read This Week
1. “U.S. Could Soon Approve MDMA Therapy—Opening An Era Of Psychedelic Medicine.”
Writing in Nature, Sara Reardon reports that the Multidisciplinary Association for Psychedelic Studies (MAPS)—a dominant research institution behind a number of important psychedelic medicine clinical trials—plans to officially request the FDA to authorize the use of MDMA for treatment of PTSD following positive results of a recently completed clinical trial.
As Reardon explains:
“MDMA allows people to confront their trauma by dampening the fight-or-flight response much in the way alcohol does, but without the confusion and forgetfulness. Whereas many PTSD therapies direct a person to concentrate on a traumatizing event—potentially retraumatizing them in the process—MDMA elevates positive emotions and allows people to make connections that might not have otherwise seemed obvious…”
While MDMA is a powerful treatment, its effects on the patient are also more pronounced than with other medications (say, for example, a cholesterol pill). That presents a problem for clinical trials—it’s kind of obvious if you are in the placebo group or not. This can sway results—making findings appear to be more positive than perhaps they really are. To solve for that problem, which threatened to be a roadblock for FDA approval, Rick Doblin, the founder of MAPS, came up with a novel protocol. As Reardon reports:
“After the treatment sessions, each participant’s symptoms were evaluated by psychologists who did not administer the drug and did not know who was in each group. With this protocol in place, the FDA has agreed to base its decisions on the reported efficacy and not take issue with the study design.”
2. WHY IT WORKS: MDMA Helps Patients Address The Emotion Regulation Deficits That Often Undermine PTSD Treatment.
Recent research has documented the promise of integrating MDMA into therapy for post-traumatic stress disorder. Indeed, “a pooled analysis of six MDMA-assisted therapy Phase II trials showed that 54% of patients no longer met criteria for PTSD.”
Yet, within the population of people diagnosed with PTSD, those who have histories of child abuse can be more difficult to treat. Successful trauma-focused treatment requires the patient to recall and modify painful and fear-producing memories. But victims of child abuse often struggle with emotional regulation and self-capacity indicators—for example, an “inability to modulate or tolerate distress,” a “lack [of] self-compassion,” and “a loss of sense of safety, trust and self-worth”—that facilitate this process.
Newly released findings from a recently concluded “randomized, double blind, placebo-controlled, multi-site Phase 3 clinical trial” in which the “vast majority (85%) of individuals reported having suffered early childhood trauma,” suggest that integrating MDMA into therapy for PTSD “can facilitate accessing painful memories and experiences that under ordinary conditions are too overwhelming and terrifying to confront.”
As the authors, led by pioneering trauma researcher and psychiatrist Bessel van der Kolk, explain:
“Participants were randomized 1:1 to receive manualized therapy with either MDMA or placebo with three preparatory and nine integrative therapy sessions…. While both treatment conditions were associated with some improvement in self experience, only MDMA Assisted Therapy, and not psychotherapy alone, significantly altered these transdiagnostic measures, with significantly greater changes in self compassion, emotion regulation [and other self-experience indicators].
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[Moreover,] for participants with low self-capacity ratings at baseline only the MDMA-Assisted Therapy condition produced significant improvements in PTSD …. This suggests that MDMA has a strong effect on these measures of emotion regulation and self-experience, even after adjusting for potential covariates and conducting multiple comparisons …. psychotherapy alone may not sufficiently compensate for the debilitating effects of deficient self-experience on being able to confront traumatic material and thus, on treatment outcome.”
3. Three-Fourths of Psychotherapists Would Inform Patients About Psilocybin-Assisted Therapy, Study Finds.
Regulatory approval of psychedelic medicine is only the first barrier to expanded access to care. The second barrier is that mental health professionals must embrace these drugs as a valid treatment option for their patients. That’s what makes the findings of a new study by researchers at the University of Texas Department of Psychiatry and Behavioral Sciences encouraging:
In a survey of 119 “practicing or in-training psychologists residing in Texas,” published last month in the Journal of Affective Disorders, “77.4 % of psychologists agreed they would inform eligible patients” about psilocybin-assisted therapy “should psilocybin be FDA approved.”
Psychedelic therapy is a serious treatment and the study shows that therapists recognize it not as a panacea, but rather as part of a broader therapeutic treatment plan. One indication from the survey study of how therapists might approach psychedelic therapy: the vast majority of therapists (91%) indicated that they wouldn’t recommend psilocybin therapy as a first treatment (meaning that psilocybin-assisted therapy often will follow other treatment attempts, such as traditional talk therapy, depending on the needs of the patient).
