The recent publication in Nature Medicine on the Phase 3 study of MDMA-assisted psychotherapy has created another wave of exuberance around psychedelic medicine. Mainstream media is now flush with articles and news segments about the findings, so I will not go into detail about those. Just for context, the general findings were 67% of PTSD sufferers who had MDMA with psychotherapy no longer qualified for a PTSD diagnosis following the trial, compared with 32% of those who received a placebo with psychotherapy. And 88% of subjects in the MDMA group experienced a “clinically significant improvement” in symptoms.
I often hear questions regarding safety and abuse potential regarding the likely FDA approval of this therapy. Therefore, I think this is a good opportunity for those who are unaware of this trial and their protocols to learn how participants are actually treated. More importantly, what does this mean for potential real world use. There is a misconception that MDMA will be prescribed to people which will eventually lead to the next epidemic on top of an existing opioid epidemic. The study participants only received three medicine treatments. Three. Administered in a facility under the supervision of medical personnel. There seems to be a reflexive answer to the use of psychedelics as medicine among parts of the psychiatric and addiction community. Drugs = Bad, no matter what context. It is just not that simple, certainly not after legitimate research is demonstrating continued efficacy and minor adverse effects.
When this therapy becomes FDA approved it will be administered under the same conditions – in a controlled setting. Patients will not be receiving prescriptions, therefore overdoses and diversion will be impossible. IIT has created a protocol that mirrors much of what is happening in this trial. What we have learned using Ketamine is the same the science has demonstrated with MDMA – the drug is only part of the equation. Current literature has shown that the greater the mystical experience, the better the outcomes. This was found regardless of dose received. Secondly, the drug without the therapy had waning effects and more adverse effects. Essentially, giving the drug alone without a therapeutic framework was problematic and did not produce lasting improvement.
There is much work to be done before IIT will offer MDMA-assisted psychotherapy, but when that day comes, we will be providing an ethical and safe practice. One that we believe will build upon the hard work done on these trials to create a protocol that maximizes the therapeutic benefit of this powerfully important medicine.