July 05, 2019
Figure 1: MDMA may improve PTSD symptoms when paired with psychotherapy.Figure 2: MDMA + Therapy significantly improved PTSD over 12 months. A small clinical trial demonstrates that MDMA (ecstasy) may have lasting benefits for PTSD patients when given alongside psychotherapy. All patients, who received both MDMA (ecstasy) and psychotherapy, had an average PTSD score of 87 prior to the study. 12 months after the study, they had an average PTSD score of 39. This finding was highly significant. (p < 0.0001)
PTSD is a surprisingly common disorder in the United States. It ranks as one of the most prevalent types of anxiety disorders.
Police officers, veterans, and firefighters witness traumatic situations as part of the job and have a higher risk of developing PTSD. This condition can impair patients for years.
One of the best treatments available today is psychotherapy. A new study suggests that MDMA, a well-known party drug also called Ecstasy, may be medically valuable in further improving PTSD when paired with psychotherapy.
A small clinical trial recruited 26 volunteers with PTSD, including veterans, police officers, and firefighters.
They were given either 30mg, 75mg, or 125mg of MDMA along with psychotherapy.
After one year, all three groups showed dramatic improvements in their PTSD symptoms.
Figure 2: MDMA may improve PTSD symptoms when paired with psychotherapy. Patients given 125mg and 75mg of MDMA showed significant improvements in their PTSD symptoms during the first month after the trial, as measured by the Clinician-Administered PTSD Scale. Patients who took 30mg of MDMA had an 11.4 point improvement, which was not significant. Patients who took 75mg of MDMA had a 58.3 improvement, with their CAPS score reduced from 82.4 to 24.1. This was highly significant with a p-value of 0.0005. Patients who took 125mg of MDMA had a 44.3 point improvement, with their CAPS score reduced from 89.7 to 45.3. This was highly significant with a p-value of 0.004.
While the researchers did not include a placebo control, they were able to show evidence of the effectiveness of MDMA through differences between different doses.
Patients that received the lowest dose of MDMA did not show significant improvement during the first month after the drug was given.
Patients who received the 75mg and the 125mg showed significant improvements suggesting that a higher dose of MDMA may be effective in treating PTSD.
Figure 3: Side Effects of MDMA as a PTSD Treatment. While this study was too small to determine side effects with certainty, the data shows some evidence that MDMA may lead to higher levels of anxiety. Those on the highest dose of MDMA had a 92% anxiety rate, compared to 57% on the lowest dose. Similarly, 75% of those on the highest dose reported "tight jaw" or "jaw clenching" compared to 0% of those on the lowest dose.
While this study was too small to identify side effects, there was some evidence that those who received MDMA had a higher risk of anxiety.
During the two weeks when they were given the treatment, participants on the highest dose were more likely to report anxiety and other similar symptoms.
This small clinical trial shows promising evidence for the usefulness of MDMA in treating PTSD.
Researchers will need to run a larger trial, preferably with a placebo control, to confirm these effects before doctors can prescribe MDMA as a PTSD treatment.
The FDA has permitted and supported further study of MDMA as a PTSD treatment. If further studies are successful, it is likely that we will see MDMA advance from just a party drug to a real therapeutic as well.
Study Type - Researchers conducted a randomized clinical trial, which is the gold standard in medical research.
Endpoints - Researchers used an objective evaluation of PTSD symptoms, which adds the validity of the results.
Study Size - While the study size was large enough to show some differences, it was too small to determine between-group differences with high certainty.
Controls - The study did not include a placebo control. A placebo control increases the validity of the findings by demonstrating that the effects seen are caused by the drug itself.
In recent clinical trials, 61 percent of 107 participants no longer had PTSD symptoms two months after MDMA-assisted psychotherapy. Sixty-eight percent were still PTSD-free a year later. In light of findings like these, the FDA recently deemed MDMA a "breakthrough therapy," putting it on the fast track for approval.
The non-profit Multidisciplinary Association for Psychedelic Studies (MAPS) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to MDMA for the treatment of posttraumatic stress disorder (PTSD). MAPS and the FDA have also reached agreement under the Special Protocol Assessment Process (SPA) for the design of two upcoming Phase 3 trials (MAPP1 and MAPP2) of MDMA-assisted psychotherapy for patients with severe PTSD.
Early studies found that 83% of patients with chronic, treatment-resistant PTSD had significant reductions in their PTSD symptoms when treated with MDMA-assisted psychotherapy compared with placebo.
Clearvue Health is not affiliated with above organizations. The information above is provided to highlight and link to useful further reading.