According to a new peer-reviewed Nature study, treatment with MDMA reduces symptoms for patients with moderate or severe PTSD.
According to the Multidisciplinary Association for Psychedelic Studies, which sponsored the study, federal regulators may consider approving this drug for wider usage as early as next year.
The FDA is expected to approve MDMA-assisted therapies in 2024. This is thanks to the efforts of hundreds of volunteers who participated in MAPS sponsored trials and thousands of donors.
In a randomized, controlled, double-blinded trial, 104 PTSD sufferers were randomly assigned to receive MDMA or a sham treatment. They then received talk therapy. The participants were assessed on both PTSD and functional impairment.
In this phase 3 confirmatory study, MDMA-AT significantly reduced PTSD symptoms and functional disability in participants with moderate or severe PTSD.
The finding that MDMA “significantly reduced PTSD symptomology compared to placebo with therapy” adds to a body literature that already indicates the substance could be a major game changer. Only about half of the patients respond to conventional therapies and medications.
Researchers say the substance helps break down barriers that would otherwise prevent patients from processing trauma.
The study states that “MDMA simultaneously incites prosocial feelings while softening responses to emotionally challenging or fearful stimuli”, potentially enhancing individuals with PTSD’s ability to benefit from therapy by reducing the sensations of threat, fear and negative emotion.
announced on Thursday that MAPS Public Benefit Corp., a subsidiary to the nonprofit MAPS will file a new application for FDA approval later this year. This could lead to FDA approval by next year. MDMA therapy would then become more widely available.
In 2017, FDA designated MDMA a ” Breakthrough Therapy ” based on Previous MAPS sponsored trials. The organization claims that findings from 18 Phase 2 and 3 trials will be the basis for the new drug application to FDA.
The new study found that not only were treatments “generally well tolerated”, but they also had robust results among participants.
The authors noted that “a substantial number of participants displayed comorbid characteristics associated with high resistance to treatment, such as major depressive disorder, multiple trauma sources (including childhood trauma and combat trauma), and dissociative subtype PTSD.” The replication of effectiveness is especially notable, given the diversity of the population and the degree of complexity of the participants.
This confirmatory phase three trial demonstrated consistent benefits of MDMA in an ethnically diverse group with longstanding moderate-to-severe PTSD and multiple comorbidities.
The researchers added that the “treatment did not differ significantly based on disease severity, alcoholism or other substance abuse disorders, adverse childhood experiences, or dissociative subtype.”
The report states that there are no new safety concerns. The report says that the common issues were “similar to previous studies” and “consistent with expected MDMA effects,” including mild, transient increases in blood-pressure and heart rate.
The study found that suicidal thoughts were “observed in both groups”, but MDMA “did not appear to increase the risk” and “no suicidal behaviors were observed.”
The study’s authors cautioned that, while MDMA may appear to be a novel option for treatment, it is not an apples-to apple comparison of treatment methods. They said that although MDMA effect sizes “were higher than those observed in SSRI-related studies,” “the superiority or inferiority of MDMA AT over SSRIs can’t be assumed without a comparison.”
The study states that “the complex relationship between SSRI history and MDMA-AT efficacy treatment was beyond the scope and sample size of the current statistical plan,” but “will be important in future studies.” Further research on MDMA in conjunction with other types of psychotherapy should also be investigated.
The authors said that it is also possible that “manualized inner directed therapy” that was developed to be used with MDMA, has value by itself given the “notable effects seen in placebo therapy.”
Some observers referred to the study as a historic one, even though practitioners of psychedelic therapies have recognized MDMA’s therapeutic potential for many years.
The publication of today’s Nature Medicine marks an important moment in the evolution in mental health care. It highlights the importance of providing our therapists the knowledge and skills necessary to provide psychedelic therapies, said Ingmar GORMAN, co-founder at Fluence. Fluence offers courses for mental health professionals on psychedelic treatment.
Researchers at New York University’s Langone Center for Psychedelic Medicine, and Imperial College London’s Centre for Psychedelic Research, found in a separate study that pairing MDMA or psilocybin with LSD or psilocybin helped people overcome “challenging” experiences when using psilocybin alone.
The federal law currently classifies all three substances, LSD, psilocybin, and MDMA, as Schedule I controlled drugs. This has hindered research for many decades. Legislators and regulators are now warming up to the idea of reforming these drugs, as more evidence suggests that they could be effective treatment tools for mental disorders.
In a statement made a year ago, Biden’s administration stated that it was “actively examining” the possibility to create a federal taskforce to investigate the therapeutic benefits of psilocybin and MDMA, ahead of their anticipated approval for prescription use. Prior to this, bipartisan congressmen, state legislators and veterans sent letters to the U.S. Department of Health and Human Services’ (HHS) head urging them to consider creating an “interagency Taskforce on the proper deployment and use of psychedelic therapy and medicine.”
The lawmakers noted at the time that Nora Volkow, director of the National Institute on Drug Abuse’s (NIDA), had stated that “the train has left the station” on the psychedelics. She also wrote that “people will use them regardless whether regulators take action.”
Sens. Cory Booker, (D) (NJ), and Brian Schatz, (D) (HI) each urged top federal officials to give an update on the research into the therapeutic benefits of psychedelics.
Late last year, the Drug Enforcement Administration proposed increased manufacturing quotas for MDMA and LSD. Psilocyn was also included. The Drug Enforcement Administration (DEA) said that it was committed to ensuring a continuous and adequate supply of controlled substances to meet U.S. medical, scientific, industrial, and research needs, as well as to maintain reserve stocks.
Australia has legalized MDMA, psilocybin and their use on prescription.
Psilocybin is associated with’significantly’ reduced symptoms of major depression after one dose, American Medical Association study finds
Photo by Pretty Drugthings via Unsplash.
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