Over the past few years, research has increasingly pointed to the potential for MDMA, commonly known as ecstasy or molly, as an adjunct to psychotherapy for treating post-traumatic stress disorder (PTSD). Two recent placebo-controlled Phase 3 clinical trials have demonstrated promising results, bringing this MDMA-assisted therapy one step closer to potential FDA approval. So what exactly is molly and what are some of the leading studies working to improve our understanding of how MDMA works?
The Latest Trial Results
The most recent trial, published in September 2022 in Nature Medicine, found that MDMA paired with psychotherapy led to significantly greater improvement in PTSD symptoms compared to psychotherapy with a placebo.
The trial was sponsored by MAPS Public Benefit Corporation, a company developing MDMA as a prescription medication. It involved 90 participants with chronic, moderate to severe PTSD who underwent MDMA-assisted therapy.
During experimental sessions, 53 participants were given MDMA while 51 received a placebo. Those who received MDMA had substantially larger decreases in the severity of their PTSD symptoms by the end of the study.
Specifically, 86.5% of the MDMA group experienced a reduction in symptoms, with 71% no longer meeting the criteria for a PTSD diagnosis. In the placebo group, 69% had some improvement, and 47.6% no longer qualified for a diagnosis.
Confirming Earlier Findings
This confirms earlier findings from MAPS’ first Phase 3 trial results published in 2021, which found a significant difference between MDMA and placebo groups.
In that study, 67% of participants who received MDMA no longer met the criteria for PTSD two months after treatment, compared to 32% who received the placebo.
Taken together, these robust Phase 3 results provide strong evidence that MDMA-assisted therapy can be an effective option for patients with treatment-resistant PTSD who have not found sufficient relief from other therapies.
Addressing an Unmet Need
PTSD is estimated to affect around 5% of the US adult population annually. However, current pharmacological and psychotherapeutic treatments have limited effectiveness, helping only 50% of patients at best.
The unmet need for better PTSD treatments is evident. If approved, MDMA-assisted therapy would be the first new option in over 20 years.
Next Steps Toward Potential Approval
Based on these positive late-stage clinical results, MAPS plans to submit a New Drug Application for MDMA to the FDA by the end of 2022, with possible approval by late 2024.
This would require rescheduling MDMA from a Schedule I controlled substance to allow for medical use. It also raises questions about therapist training standards and insurance coverage that will need to be addressed.
Cautious Optimism for Study Results for MDMA-Assisted Therapy
While some experts urge caution about costs and side effects, many see MDMA-assisted therapy as a potentially “lifesaving” treatment option for PTSD patients in dire need of new, more effective solutions.
With two successful large-scale trials demonstrating a clinically meaningful benefit, there is growing excitement and cautious optimism surrounding MDMA’s prospects as the first psychedelic-assisted therapy to gain regulatory approval.
What is MDMA?
MDMA (3,4-methylenedioxymethamphetamine) is a synthetic drug that alters mood and perception. It produces feelings of increased energy, pleasure, emotional warmth, and distorted sensory and time perception.
First synthesized by Merck in 1912, MDMA was used in the 1970s to enhance psychotherapy. It was made illegal in 1985 due to recreational use.
How MDMA-Assisted Therapy Works
MDMA-assisted therapy utilizes 2-3 day-long sessions with specially trained therapists. Participants receive MDMA or a placebo and undergo 8 hours of psychotherapy.
MDMA enhances the therapeutic process by increasing compassion, reducing fear, and allowing patients to revisit trauma without being overwhelmed. This enhances the alliance between patient and therapist.
The MDMA experience provides a window for patients to emotionally engage with their trauma, while the therapists help them process it in a meaningful way.
Safety Profile of MDMA
MDMA has been found to be sufficiently safe when taken a limited number of times in moderate doses and in controlled settings. However, recreational use of ecstasy/molly may involve higher doses and risks.
In clinical trials, some participants experienced temporary side effects like nausea, muscle tension, and anxiety. A small number had cardiovascular effects, which underscore the need for medical screening.
Suicidal ideation occurred at low rates in both placebo and MDMA groups. No suicide attempts were reported.
Proper protocols, therapist training, and medical screening help minimize risks of MDMA-assisted therapy. More research is still needed on long-term outcomes.
Other Psychedelics Being Studied
In addition to MDMA, other psychedelics are being researched as potential adjuncts to psychotherapy for mental health conditions:
- Psilocybin (magic mushrooms) for depression, anxiety, and addiction
- Ketamine for depression and PTSD
- Ibogaine for addiction disorders
- Ayahuasca for depression and PTSD
Ongoing studies are evaluating the safety, optimal protocols, and therapeutic potential of various psychedelic-assisted therapies.
The Future of Psychedelic Medicine
After decades of prohibition, we are now in a psychedelics research renaissance. Growing evidence for benefits in treating PTSD, depression, and other conditions may lead to FDA-approved clinical uses.
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