FDA Labels MDMA A 'Breakthrough Therapy' - What Does That Mean?
MDMA is typically thought of as a party drug, but the FDA has recently praised MDMA’s ability to successfully treat post-traumatic stress disorder.
MDMA
MDMA, otherwise known as 3,4-Methylenedioxymethamphetamine, is an intoxicating stimulant known for its ability to increase energy levels and induce euphoria. MDMA is commonly illicitly used as a party drug which has recently gained attention for its potential effects on cognitive function.
MDMA As A PTSD Treatment
The Multidisciplinary Association for Psychedelic Studies recently released a paper on their phase 2 clinical trials which examined MDMA’s efficacy as a treatment for PTSD.
The study gave 75-125mg doses of MDMA to patients with PTSD during 8-hour psychotherapy sessions. These sessions occurred either two or three times, with a month between each session. Analysis of PTSD and depressive symptoms of the participants showed that after two treatment sessions, 54.2% of the MDMA treated group no longer met PTSD diagnostic criteria, while only 22.6% of the control group participants no longer met PTSD diagnostic criteria. The treatment group also showed a greater improvement in depressive symptoms than the control group. The MDMA receiving participants also showed good tolerance to the doses given.
FDA Praises MDMA
So what does this mean for MDMA?
As well as allowing for the Multidisciplinary Association for Psychedelic Studies to continue further research in phase 3 trials, the significance of these results also led the FDA to describe MDMA as a breakthrough therapy with the potential to even improve on existing PTSD therapies. While more research is needed to ensure the safety of MDMA and fully understand its mechanisms of action, it is a very promising development in the treatment of PTSD.
How MDMA Might Improve PTSD Treatment
MDMA’s effects on emotion, which made it popular as an illicit party drug, are also thought to be responsible for its therapeutic potential as a PTSD treatment. MDMA has been shown to increase levels of neurotransmitters such as dopamine, serotonin, and noradrenaline. MDMA is thought to activate monoamine release through transporter protein reversal and the blocking of reuptake, which leads to increased serotonin and norepinephrine levels and a slightly less potent effect on dopamine levels. Serotonin, norepinephrine, and dopamine all play key roles in cognitive function, fear regulation and mood and could all therefore significantly affect PTSD symptoms, and more importantly, aid in one’s ability to openly communicate about their past traumatic experiences.
PTSD is also characterized by glucocorticoid hypersensitivity and improper functioning in the hypothalamic-pituitary-adrenal axis (HPA axis). This may be another mechanism of action for MDMA as MDMA has been shown to modulate glucocorticoid levels in the HPA axis, possibly helping to stop the dysregulation that could lead to PTSD.
MDMA contains paired molecules called S and R enantiomers and it is thought that these molecules may also play a key role in MDMA’s positive effect on psychiatric disorders due to certain enantiomers having been used in psychiatric treatment previously to improve the effects of some medications. While more research is needed on S and R enantiomers, it is thought that they may improve the therapeutic index of MDMA and therefore increase its treatment potential.