MDMA assisted therapy

What is MDMA? 

MDMA, known medically as 3,4-Methylenedioxymethamphetamine, is a psychoactive substance known to produce feelings of increased empathy, pleasure, and energy while also altering sensations to the user. It’s illegal in the vast majority of countries, including the United States. However, special exceptions on MDMA’s prohibition have been made for research purposes and FDA clinical trials to treat various mental health conditions, including PTSD and depression. 

MDMA functions primarily by augmenting the activity of the noradrenaline, dopamine, and serotonin neurotransmitters in certain parts of the brain. Technically speaking, it is part of the substituted amphetamine family of drugs. 

MDMA was developed in 1912 by a German pharmaceutical company. In 1985, the DEA placed MDMA under Schedule I and made it illegal. In 2017, the FDA granted Breakthrough Therapy Designation for MDMA-Assisted Psychotherapy for PTSD based on strong preliminary evidence for the treatment of PTSD. 

Due to its hallucinogenic and stimulant effects, it’s commonly abused as a street drug. It’s important to note that MDMA is illegal and carries a strong punishment unless administered and prescribed under the supervision of a licensed professional. 

What is MDMA therapy? 

MDMA-assisted therapy is a potential treatment for post-traumatic stress disorder (PTSD) currently under intense research to determine its efficacy. The goal of MDMA therapy is to reduce PTSD symptoms and enhance overall wellbeing, functioning, and the quality of life for patients. 

Through MDMA therapy, both psychotherapeutic and biological approaches are utilized to help facilitate the processing of trauma. This is designed to help eliminate or decrease stress reactions and chronic hyperarousal to triggers. This is done in contrast to directly suppressing such symptoms that might result from reactions.

Currently, MDMA therapy is only available as part of clinical trials. It is anticipated that MDMA-assisted therapy will be available to treat PTSD in 2022 pending FDA approval. It is currently in Phase III of Clinical Trials with the FDA. 

What are the current clinical trials for MDMA therapy? 

Currently, the only clinical trial being conducted on the medical efficacy of MDMA therapy is in relation to PTSD. The Multidisciplinary Association for Psychedelic Studies (MAPS) has recently reached an agreement with the Food and Drug Administration (FDA) for Phase 3 of clinical trials which are set to finish in 2022. This means that the FDA could potentially approve this treatment by 2022. Phase 2 clinical trials are also being initiated in Europe.  

What conditions is MDMA used to treat? 

There is research underway to explore the therapeutic effects of:

• MDMA for PTSD
• MDMA for Depression
• MDMA for Anxiety
• MDMA for OCD
• MDMA for substance abuse
• MDMA for opioid addiction
• MDMA for expansion of consciousness

What do experts say about using MDMA to treat mental health conditions? 

MDMA-therapy is a burgeoning field of medical research with some of the most important clinical trials currently being conducted. Here are some quotes from experts about the current state of MDMA therapy, the potential benefits it could offer, and what the future might hold for MDMA-therapy. 

“With such encouraging data, including evidence of long-term effectiveness after only two or three MDMA-assisted psychotherapy sessions, there is now no doubt that this research should be expanded to larger clinical trials.” – Dr. Michael Mithoefer

“Our initial results there are promising, suggesting that MDMA-assisted psychotherapy may also be a powerful future treatment option for the growing number of men and women who suffer from PTSD as a result of war, terrorism, and natural disasters.” – Brad Burge, Director of Communications for MAPS

“If researchers continue to see such strong results, the treatment could be available by 2020, but that’s an unacceptably long time to wait for people with PTSD and their families, so we’re doing everything we can to accelerate the research.” – Brad Burge, Director of Communications for MAPS

What are the risks of MDMA therapy? 

MDMA-assisted therapy comes with some risks of which all patients should be made aware. Early studies revealed that MDMA-therapy can produce negative thoughts and experiences since doctors can’t select what kind of feelings are elicited. This lack of control is a potential problem facing the implementation of MDMA therapy. Regular use of this substance can lead to psychobiological problems, memory issues, and serotonergic neurotoxicity. 

Here are some other short-term issues potentially associated with MDMA therapy: 

• Verbal memory deficits 
• Spatial memory deficits
• Slow processing speeds
• Impairments in executive functioning 

What happens during MDMA therapy sessions? 

How long is a typical session? 

Since MDMA therapy is still being researched intensely, this question can’t be answered with any degree of accuracy yet. If MDMA therapy is FDA-approved and MDMA clinics start offering treatments, the session lengths will be more easily determined. An educated guess would place the total time around six to eight hours depending on how much MDMA is administered and how long the effects last. 

What does the entire treatment plan or “protocol” look like? 

In some current studies for MDMA therapy, patients are provided with the determined amount of MDMA, which is typically administered orally. The patient is closely monitored by a medical professional. Soothing and emotionally-proactive songs are played while the therapist engages the patient in conversation. 

After a few hours, another pre-determined and prescribed dose of MDMA is orally administered in some cases. Therapists might work with patients for up to six hours or until the desired effects of the substance wear off. Throughout the session, therapists attempt to make patients feel comfortable while also exploring the underlying causes of the PTSD. 

What will I feel during the MDMA therapy session? 

In MDMA-assisted therapy, there have been reports of enhanced empathy and relaxation, reduced feelings of defensiveness and anxiety when engaging with traumatic memories, improved closeness between therapist and patient, along with a motivation to become engaged with the therapy and introspective thoughts. Some potential side effects associated with the procedures, which can last for a few days after the procedure or just a few hours include:

• Feeling cold 
• Tightness 
• Loss of appetite 
• Nausea
• Headache
• Low mood
• Fatigue
• Depression 
• Impaired balance 

How much does MDMA therapy cost? 

The cost of MDMA therapy is not yet known since this procedure is still very much in its infancy. As more studies are conducted and more becomes known about MDMA therapy, we’ll likely see more companies offering it. These initial MDMA clinics will set the standard for the cost of MDMA therapy. However, Brad Burge, the Director of Communications for MAPS, has estimated that the out-of-pocket cost for patients would range between $5,000 and $10,000 for a 12-week treatment plan. 

Am I eligible for insurance coverage?

Unfortunately, it’s difficult to determine whether or not insurance will cover MDMA-assisted therapy for PTSD at this time. As more research is conducted, and this procedure becomes more accepted, there are higher chances that insurance companies will offer coverage. The state of MDMA clinics will also factor in this determination. Until that time, however, it’s not determinable. 

Does MDMA therapy intervene with my current treatment plan? 

Currently, there hasn’t been sufficient study in this area. If you plan on undergoing MDMA therapy, it’s paramount you share any current treatments you’re undergoing with your primary care physician and the MDMA clinics where you’re receiving the treatment. MDMA’s strong impact on the brain’s neurochemistry might make it intervene with certain treatment plans. 

What to look for in a good MDMA clinic? 

Currently, there aren’t any MDMA clinics authorized to offer MDMA therapy outside of clinical trials. With trials reaching their conclusion, the FDA is set to approve or deny this treatment. If approval is granted, here are some characteristics you should look for in good MDMA clinics: 

Proper Qualifications: Without FDA-approved guidelines, it’s tough to say what qualifications MDMA clinics will need to meet in order to offer MDMA therapy. Whatever these requirements are, it’s critical to ensure the clinic you choose has proper certifications, documentation, qualifications, etc. 

Knowledgeability: When new therapies are approved by the FDA, it’s important for patients to avoid any potential scams or low-quality MDMA clinics. You need to ensure the MDMA clinics you choose are highly knowledgeable about the procedure. They should be able to satisfactorily answer any questions you may have. 

Experience: Since MDMA therapy isn’t an FDA approved procedure yet, it might be tough to find MDMA clinics with extensive experience. However, you should attempt to find a clinic with medical professionals who are familiar with the procedure. 

Although MDMA therapy is still undergoing extensive research, it has revealed some promising results. If approved by the FDA, those suffering from PTSD could see this treatment grow in popularity and general acceptance with MDMA clinics popping up across the country.