MDMA Assisted Therapy

Experienced mental health clinicians and researchers, Cole Marta, MD, and Brooke Balliett, LMFT, have conducted and published the results of four clinical trials examining the potential of MDMA-Assisted Therapy to overcome debilitating PTSD symptoms. This treatment, which includes a drug called midomafetamine (MDMA) paired with trauma-focused psychotherapy, is currently under review by the FDA. Despite showing clinically significant efficacy and minimal safety risks, in August 2024 the FDA made the decision to decline commercial approval of MDMA-Assisted Therapy at this time, instead requesting additional clinical trials to gather more data.

The California Center for Psychedelic Therapy remains committed to accessible, safe, and effective, MDMA-Assisted Therapy and our clinical director remains engaged in MDMA-Assisted clinical trials within the VA system and beyond. Once the FDA receives the data required to approve MDMA as a new drug for use within trauma psychotherapy, the Center will have the most experienced and qualified treatment teams available in Southern California to provide this therapy.

Please note that MDMA-assisted therapy has not yet been approved by any regulatory agency in the USA and will not be available until at least 90 days after FDA approval is achieved, which could be as delayed as 2027. Reach out today to have your email placed on our mailing list for timely updates on the advancement of MDMA-assisted therapy, including any additional clinical trials in the area as they become available in the coming months.

What is MDMA-Assisted Therapy?

MDMA-Assisted Therapy has not yet been approved by any regulatory agency in the USA. In August 2024, the FDA reviewed the treatment as a potential new offering for treatment of PTSD outside of clinical trials.  Despite the successful results of multiple Phase II and III clinical trials demonstrating extremely effective outcomes, the FDA has required additional studies be conducted prior to any approval.  Should the FDA approve this unique trauma treament, we will be offering it at that time.  Until then we will continue to evaluate the safety and efficacy through addtional research. 

The California Center for Psychedelic Therapy in Hollywood has completed 4 clinical research trials for MDMA-Assisted Therapy since 2017 under the direction of our founders, Brooke Balliett LMFT and Cole Marta, MD.  The unique trauma specialists at our center are the most experienced in Southern California- our research has been published in peer-reviewed journals and our clinical director, Brooke Balliett, LMFT, is one of only 7 mentor trainers of MDMA-AT in the world. 

How does MDMA-Assisted Therapy work?

MDMA-assisted therapy causes pharmacologic effects by releasing dopamine, serotonin, norepinephrine, and other neurotransmitters, leading to increases in several hormones. MDMA can boost feelings of empathy, well-being, energy, and compassion.  When combined with trauma-focused psychotherapy, MDMA may help you better cope with the debilitating impacts of difficult or traumatic situations.  

Is MDMA-Assisted Therapy right for me?

MDMA-Assisted Therapy has not yet been approved by any regulatory agency in the USA.  In August 2024, the FDA evaluated the outcomes of our research and requested more data.  You might be a candidate for MDMA-Assisted Therapy if you are experiencing symptoms of traumatic stress and PTSD.  Until more data is submitted to the FDA for further review, the only way to safely and legally access the treatment in the US is via clinical trials. 

Signs of PTSD include:

• Thoughts of suicide
• Avoidance of people, places and experiences associated with traumatic events
• Distressing or intrusive memories
• Flashbacks
• Nightmares
• Depression
• Anxiety 
• Getting startled easily
• Always being on guard

Email the California Center for Psychedelic Therapy today to get up to date information regarding eligibility and other updates as the FDA provides additional guidelines for the treatment in the coming months. 

What are the benefits of MDMA-assisted therapy?

MDMA-assisted therapy can help you address and minimize the overwhelming impact of past trauma to lessen bothersome or disruptive symptoms. This treatment can allow you to thrive after a PTSD diagnosis, even if traditional medications have failed. You may gain insight, peace of mind and increased capacity in your career and interpersonal relationships. 

What can I expect during MDMA-Assisted Therapy?

MDMA-Assisted Therapy has not yet been approved by any regulatory agency in the USA.  Since 2017, MDMA-Assisted Therapy at the California Center for Psychedelic Therapy has been offered via clinical trials and we are prepared to offer MDMA-Assisted Therapy as soon as it is FDA approved, hopefully sometime before 2027.  The treatment involves ingesting midomafetamine (MDMA) under medical supervision. You also undergo psychotherapy, revisiting past emotions and events with two highly trained, trauma-informed licensed psychotherapists.  

MDMA-Assisted Therapy also includes preparatory and integration therapy sessions, in addition to therapy in conjunction with administration of the drug. Recreational use of MDMA doesn’t produce the therapeutic effects of MDMA-Assisted Therapy. The results are long-lasting, revitalizing, and highly effective.