2023-10-09 16:05:52
Just throw MDMA to support trauma therapy? This could actually work – the active ingredient is already approved in Australia. You can find out what the situation is here.
Since 2017, the Food and Drug Administration (FDA) has considered the psychoactive drug 3,4-methylenedioxy-N-methylamphetamine, or MDMA for short, as a promising treatment additive for post-traumatic stress disorder (PTSD). At that time, the American authority awarded the substance a “Breakthrough Therapy Designation” – a way to get promising treatments through the approval process more quickly.
Miracle or daring?
Now results from a new phase III study have further underlined the potential benefits of MDMA. The team led by neurologist Jennifer Mitchell from the University of California, San Francisco, had already published a first phase III study on the effectiveness of MDMA-supported psychotherapy in 2021. In both studies, participants underwent 18 weeks of psychotherapeutic sessions. They took either MDMA or a placebo three times. The result: The drug significantly reduced PTSD symptoms compared to the placebo. At the end of the study, 71 percent of the test subjects no longer met the criteria for PTSD, compared to 48 percent in the placebo group. These are clear figures – so should approval come as quickly as possible?
“It’s still too early for that,” says Dr. Ulrike Schmidt, Deputy Director of the Clinic for Psychiatry and Psychotherapy at the University Hospital of Bonn. The acute effects are impressive, but there are too many unanswered questions. Above all, the long-term effects and side effects, which were not recorded in both studies – this is also what the authors themselves point out.
MDMA vs. Methylphenidate
Schmidt also doubts whether the comparison with a non-active placebo is sufficient. In some studies, researchers use a lower dose of MDMA as a control. “Methylphenidate is being discussed as another possibility, so to speak as an active placebo,” says Schmidt. This drug can be used to treat attention-deficit/hyperactivity disorder (ADHD). The advantage: Methylphenidate also has stimulating properties, but a different mechanism of action than MDMA. This would make it easier for those treated to distinguish between receiving MDMA or the placebo during the study examination.
In the new study, Mitchell and her team also expanded the groups of people represented to include ethnically diverse PTSD sufferers. That’s a good start, says Schmidt. “Nevertheless, more naturalistic studies are still needed.” Because strict exclusion criteria also applied here. No one who was diagnosed with certain other mental illnesses, such as a personality disorder, was allowed to take part. “In reality, people with traumatic stress in childhood often meet the criteria for a personality disorder,” says Schmidt. Cardiovascular diseases or addiction to addictive substances are also not uncommon among those affected – both of which prohibited participation in the studies. It is also important to find out which types of trauma MDMA could work on – after all, it makes a big difference to the clinical picture of PTSD whether patients deal with an accident in adulthood or chronic abuse in childhood.
Exposure therapy is essential
To date, the focus in the treatment of PTSD has been on exposure therapy, including, for example, trauma-focused cognitive behavioral therapy. In MDMA-assisted psychotherapy, however, details of traumatic experiences are not specifically discussed. Schmidt does not believe that this component of PTSD therapy can be completely eliminated for a lasting effect. “It would be interesting to see how MDMA affects the effect of classic exposure therapy.”
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Many aspects are therefore unclear – the mechanism of action and a possible risk of addiction after treatment should also be the focus of research. Schmidt emphasizes: “I am neither for nor against MDMA therapy. My clear point of view: It is currently not possible to say how helpful and safe the method will be in the long term.”
Is approval in the EU coming soon?
Nevertheless, the FDA could soon grant approval based on the successful phase III studies. The Multidisciplinary Association for Psychedelic Studies (MAPS) is planning a corresponding application for this year. In Australia, the Therapeutic Goods Administration (TGA) caused heated discussions at the beginning of 2023 when it approved MDMA for the treatment of PTSD by certified psychiatrists (DocCheck reported). And in Switzerland, patients have been able to be treated with MDMA outside of medical studies for eight years using special approvals – if the usual therapies do not work sufficiently for them.
It is difficult to predict how long it will take to be approved in Germany. Schmidt believes: “If the FDA gives the green light, things will happen quite quickly for us too.” However, mere approval is not enough. A lot still needs to be put into practice in terms of practical implementation, such as the training and certification of doctors who are then actually allowed to administer the substance. This can take time: In Australia, no one has been treated with this therapy so far, although it has been permitted since July.
Sources
Dr. Ulrike Schmidt, deputy director of the Clinic for Psychiatry and Psychotherapy at the University Hospital of Bonn
https://www.ukbonn.de/psychiatrie-und-psychotherapie/klinik/ambulante-behandlung/ambulanz-fuer-traumafolgestoerungen/
Feduccia, A. et al. (2023). The need for establishing best practices and gold standards in psychedelic medicine. J Affect Disord. 332:47-54. Doi: 10.1016/j.jad.2023.03.083
https://www.sciencedirect.com/science/article/pii/S0165032723004378
Mitchell, J. M. et al. (2023). MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nat Med. Doi: 10.1038/s41591-023-02565-4
https://www.nature.com/articles/s41591-023-02565-4
Mitchell, J. M. et al. (2021). MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nat Med. 27:1025-1033. Doi: 10.1038/s41591-021-01336-3
https://www.nature.com/articles/s41591-021-01336-3
Mithoefer, M. C. et al. (2019). MDMA-assisted psychotherapy for treatment of PTSD: study design and rationale for phase 3 trials based on pooled analysis of six phase 2 randomized controlled trials. Psychopharmacol. 236:2735-2745. Doi: 10.1007/s00213-019-05249-5
https://link.springer.com/article/10.1007/s00213-019-05249-5
Bies et al. 2023. The risk of methylphenidate pharmacotherapy for adults with ADHD. Pharmaceuticals. 16(9):1202. Doi: 10.3390/ph16091292
https://www.mdpi.com/1424-8247/16/9/1292
Posttraumatic stress disorder: S3 guidelines of the German-speaking Society for Psychotraumatology (DeGPT), version December 19, 2019
https://register.awmf.org/assets/guidelines/155-001l_S3_Posttraumatische_Belastungsstoerung_2020-02_1.pdf
Lewis, C. R. et al. (2023). Pilot study suggests DNA methylation of the glucocorticoid receptor gene (NR3C1) is associated with MDMA-assisted therapy treatment response for severe PTSD. Front Psychiatry. 14:959590. Doi: 10.3389/fpsyt.2023.959590
https://www.frontiersin.org/articles/10.3389/fpsyt.2023.959590/full
Sarmanlu, M. et al. (2023). MDMA-assisted psychotherapy for PTSD: Growing evidence for memory effects mediating treatment efficacy. Progr Neuro-Psychopharmacol Biol Psychiatry. 128:110843.]
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