Please note: MDMA for treating mental health disorders remains experimental. The following is to provide you with more information on the topic, which will be updated as we know more, and especially if FDA approval is granted.


What is MDMA?

MDMA (3,4-methylenedioxymethamphetamine) is most widely known as the recreational "street drug" Ecstasy (aka "Molly," "Mandy," "Adam," "Empathy," etc.). Its creation dates back to the early 1900s, later becoming used in the 1970s during psychotherapy sessions to help facilitate patient access, processing, and communication of traumatic experiences. In the mid-1980s, however, MDMA was controversially made a Schedule I drug under the Controlled Substances Act, leading to a reduction in research on its utilization in treating mental health disorders and making it illegal for recreational use. However, given new research showing its potential to serve as a therapeutic catalyst when combined with psychotherapy for those suffering from PTSD, the FDA is giving it a fresh look. It is now anticipated that MDMA will be approved within the next year(s) for specific clinical indications. Because of the potential for abuse, it is anticipated that this will require tight regulation in most states under the direct supervision of trained practitioners and in conjunction with psychotherapy.

How does it work?

MDMA acts centrally in the brain to increase production of neurotransmitters, particularly serotonin, but also dopamine and norepinephrine. Being predominantly serotonergic, there is a resultant decrease in feelings of depression, anxiety, and a particular reduction in the fear response mediated by the amygdala. Other positive effects include feelings of closeness as well as enhanced compassion and empathy, both for oneself and for others. The lesser dopaminergic and noradrenergic effects increase arousal and awareness, which can help motivate patients in participating in therapy and extinguish the fear response in recalling past trauma. While the science is fascinating and there are many more mechanisms behind its reported benefits in the medical literature (e.g., oxytocin release, increased BDNF alpha levels, etc.), the clinical result is a dramatic enhancement in the ability of a patient to participate in psychotherapy that is primarily aimed at those with trauma-related mental health disorders, particularly PTSD. To date, the data strongly indicates that it is highly effective when used for this purpose and combined with psychotherapy (MDMA-assisted psychotherapy).

What is it indicated for?

At this time, MDMA-assisted therapy remains investigational but is gaining traction quickly as an effective means to treat patients with PTSD. However, many if not most people suffering from chronic mental health disorders have some degree of past trauma (both emotional and/or physical) that plays a role in preventing them from finding peace and healing. Further studies are ongoing looking at its use for alcohol use disorder as well as social anxiety associated with autism. Long-term use of MDMA has the potential for negative consequences, and it is highly advised that use be limited to therapeutic indications only.

When will it be available?

This is a difficult question to answer. At present, Lykos Therapeutics has submitted a new drug application to the FDA which was accepted and has been granted priority review. The FDA approval process can be drawn out, and while the data is promising it is anticipated that there will be tight regulations and protocols for utilization as a therapy. We will continue to monitor the progress, as it is our hope to incorporate MDMA into our practice - the data looks good!

What are some alternative treatments in the meantime?

While MDMA may still be a year or more out of reach for patients outside the clinical research setting, IV ketamine infusions have been shown to reduce symptom severity in individuals with chronic PTSD. While research is ongoing, recent trials using ketamine for the management of PTSD have shown rapid symptom relief and effects that can be maintained over weeks. These effects correlate with a reduction in the activity of regions of the brain responsible for the reactivation of traumatic memories, which modulates the fear response to past trauma. Long-term durability studies are ongoing, and it is important that any such medical therapy is rooted in trauma-focused psychotherapy. If interested in learning more, give us a call! Meanwhile, we will continue to closely monitor MDMA as an emerging therapy, with plans to offer it at our clinic upon FDA approval (hopefully soon!).