Lancet Psychiatry
May 1, 2018
Michael C Mithoefer, Ann T Mithoefer, Allison A Feduccia et al.
443 citations
A randomized, double-blind, phase 2 clinical trial tested MDMA-assisted psychotherapy for post-traumatic stress disorder in military veterans, firefighters, and police officers. Participants were randomly assigned to receive different doses of MDMA during psychotherapy sessions. The findings revealed that the active dose of MDMA led to significant and lasting reductions in PTSD symptoms compared to the lower dose, indicating that this innovative therapeutic approach can effectively treat this condition and provide significant relief for individuals with profound trauma.
Psychopharmacology (Berl)
November 20, 2017
Allison A. Feduccia, Julie Holland, Michael C. Mithoefer
79 citations
Posttraumatic stress disorder (PTSD) is often treated with daily medication, but such pharmacotherapy does not provide definitive treatment and side effects are problematic. Trauma-focused psychotherapies are more likely to achieve remission but have high dropout rates and are ineffective for many patients. Research into drugs that might increase the effectiveness of psychotherapy is a logical next step. The most promising drug studied as a catalyst to psychotherapy for PTSD is MDMA (Ecstasy), which stimulates release of hormones and neurochemicals affecting key brain areas for emotion and memory processing. Phase 2 clinical trials of MDMA-assisted psychotherapy for PTSD show favorable safety outcomes and large effect sizes, warranting expansion into multi-site phase 3 trials set to commence in 2018. Brain imaging and animal models are elucidating neural mechanisms, though much remains unknown.
Hum Psychopharmacol
March 1, 2014
Rick Doblin, George Greer, Julie Holland et al.
48 citations
This article responds to and critically re-evaluates a prior review of 25 years of empirical research on MDMA (ecstasy). It argues for a more balanced understanding of the drug's effects, emphasizing that controlled therapeutic contexts can yield positive psychological outcomes and beneficial subjective experiences, contrary to earlier conclusions that focused predominantly on harms. The response highlights the need to separate recreational use from clinical applications and calls for nuanced interpretation of prior data to inform mental health research.
Psychopharmacology (Berl)
November 21, 2020
Allison A. Feduccia, Lisa Jerome, Michael C. Mithoefer et al.
39 citations
In four phase 2 trials of MDMA-assisted psychotherapy for PTSD, participants who tapered off antidepressant medications before treatment had worse outcomes than those who did not taper. The non-taper group had significantly lower PTSD symptom scores (mean 45.7 vs. 70.3) and depression scores (mean 12.7 vs. 22.6) at the primary endpoint, and 63.6% no longer met PTSD criteria compared to 25.0% in the taper group. Recent exposure to antidepressants that target reuptake transporters may reduce treatment response to MDMA-assisted psychotherapy.
Front Neurol
July 29, 2021
Mia Khan, Gregory T. Carter, Sunil K. Aggarwal et al.
33 citations
Stroke and traumatic brain injury (TBI) are leading causes of disability, with nearly half of severe TBI patients left with major disability despite rehabilitation. Pharmacologic treatment for brain injury is still in its infancy. Recent clinical trials have begun testing psychedelic therapeutics for brain injury. This narrative mini-review summarizes studies on psychedelic therapeutics and brain injury. Recent in vitro, in vivo, and case report studies suggest psychedelic pharmacotherapies may influence future brain injury treatment by modulating neuroinflammation, hippocampal neurogenesis, neuroplasticity, and brain complexity. Historical safety data on some substances could serve as phase 0 and phase I studies, and further phase II trials will clarify how these drugs may treat TBI and reperfusion injury from stroke.
Journal of Clinical Medicine
June 7, 2022
Mitchell Arnovitz, Andrew Spitzberg, Ashkhan J. Davani et al.
29 citations
Negative symptoms of schizophrenia, such as social withdrawal and lack of motivation, contribute heavily to the economic burden of the disease and have no FDA-approved treatments. This review argues that MDMA, a schedule I substance known to enhance social interaction and empathy, may offer a novel therapeutic approach. The authors examine literature on negative symptoms, existing treatments, and MDMA-assisted therapy, concluding that recent evidence suggests MDMA can be safe and potentially effective for treating negative symptoms. The review also discusses safety considerations and possible mechanisms of action, including MDMA's ability to induce metaplasticity in the brain.
Psychopharmacology (Berl)
November 1, 2024
Allison A. Feduccia, Lisa Jerome, Michael C. Mithoefer et al.
6 citations
Taking certain reuptake-inhibitor medications (such as SSRIs) before MDMA-assisted psychotherapy can affect how well the treatment works. Discontinuing these medications appears to alter patients' therapeutic outcomes. The original article that reported this finding has been retracted.