https://www.theguardian.com/science/2016/dec/01/fda-mdma-ptsd-final-trials
The meat of the article:
If the ensuing studies provide positive results, MDMA could be approved for prescription use by 2021. Around 50% of drugs fail at this stage, however.
The US Food and Drug Administration (FDA) has given the green light to phase three trials of MDMA to treat post-traumatic stress disorder, the final phase of validation required to turn the party drug into a legal medicine.
The treatment involves giving patients the drug just three times once a month during long talking therapy sessions, interspersed with weekly sessions without the drug. Early trials of the drug, currently listed as a schedule 1 substance by the Drug Enforcement Administration along with heroin and cocaine, have shown encouraging results for patients with treatment-resistant PTSD.
Moving from phase two to phase three shows we have strong scientific reason to believe that MDMA is an effective treatment for PTSD in therapy. The fact the FDA is ready to move forward with phase three signals that they agree, said Brad Burge, from the Multidisciplinary Association for Psychedelic Studies (Maps), a not-for-profit based in Santa Cruz, California, that has spearheaded efforts to turn MDMA into a medicine.
James CJ Hardin suffered with the disorder for years following his three tours in Iraq and Afghanistan. He had nightmares and insomnia and loud sounds or flashes of light could send him into a state of anxiety. He was given psychotherapy and prescribed antidepressants and anti-anxiety tablets, but nothing worked.
That is, until he he enrolled in one of Maps trials of MDMA-assisted psychotherapy. Hardin experienced a dramatic turnaround in his mental health within three months, and no longer has PTSD.
It has allowed me to be a productive member of society and given me new hope, he said.
The meat of the article:
One South Carolina study involved 20 patients, mostly victims of sexual abuse, who had suffered from PTSD for more than 19 years. It was a placebo-controlled study, so all patients were given the same therapy, but only some were given the MDMA; 83% of those given the MDMA no longer met the criteria for PTSD following treatment, compared with 25% of those who were not given the drug. The results have held for several years.
Maps has funded a total of six phase two studies of the drug, in which 136 patients have undergone MDMA-assisted therapy. Phase three trials require bigger groups of patients, at least 230 people, across different countries.
Maps submitted data from its phase two trials along with plans for phase three to the FDA a month ago. On 29 November, the FDA gave the final phase of trials the go-ahead, subject to further clarification on a few technical details, including how to ensure double blinding with a drug whose effects are so dramatic. The recruitment of patients is scheduled to start in June 2017.
If the ensuing studies provide positive results, MDMA could be approved for prescription use by 2021. Around 50% of drugs fail at this stage, however.