The drug MDMA is emerging as a promising tool for people suffering from post traumatic stress disorder (PTSD).
After years of experimental research, the Food and Drug Administration (FDA) has granted “breakthrough therapy” status for MDMA as a potential treatment for PTSD. The drug is not FDA approved, but the designation makes it easier for clinical trials to test its safety and effectiveness.
The non-profit research group, Multidisciplinary Association for Psychedelic Studies (MAPS), announced the designation on its website last week. The group, which has advocated for MDMA research for years, said the FDA has agreed the drug may have a meaningful advantage over available medications for PTSD.
Only two drugs are currently approved for treating PTSD: Zoloft and Paxil.
WATCH: Researchers at University of British Columbia talk PTSD and MDMA
More commonly known as its street names ecstasy or Molly, MDMA (methylenedioxymethamphetamine) is a psychoactive drug that decreases fear and defensiveness while increasing trust and empathy — but often followed by an emotional crash.
The drug increases the release of oxytocin and prolactin (hormones associated with trust and bonding), allowing patients to discuss their memories openly, according to MAPS. This is helpful as the stress of recalling events can trigger anxiety and depression in PTSD patients.
In recent years, some in the scientific community have suggested it could have medical benefits.
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The FDA approved Phase 3 trials of the MDMA-assisted psychotherapy for patients with severe PTSD. The treatment package combines psychotherapeutic techniques with three administrations of MDMA.
In previous phases of clinical trials, the drug was shown to offer significant relief to sufferers of the psychological disorder.
For example, of the 107 participants in the Phase 2 trials, 61 per cent no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months following the treatments. At the 12-month follow-up, 68 per cent of the participants no longer had PTSD.
“Reaching agreement with FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” Amy Emerson, executive director of the MAPS Public Benefit Corporation said.
“Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly.”
The Phase 3 trials will look at the efficacy and safety of MDMA-assisted psychotherapy in 200-300 participants with PTSD, aged 18 and older, at places in the U.S., Canada and Israel.
MAPS still needs to fund Phase 3, which could cost around US$25 million. If the group does find the financing, the trials will start in the spring of 2018 and finish by 2021.
There is a reason many pharmaceuticals aren’t interested in investing in the treatment, according to Mark Haden with MAPS Canada.
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“Psychedelics can’t be patented by large pharmaceutical companies, and if we can’t patent it, they are not going to make a huge amount of money,” he said.
Treatment, like the DMA-assisted psychotherapy, tends to be short and it’s not ongoing, he added.
“It’s only used a couple of times and no financial investment of company to promote it because it works…as opposed to giving someone a drug for the rest of their lives.”
While some people in the medical community are becoming increasingly intrigued by the experiments, others have voiced their concerns.
“I think it’s a dangerous substance,” Andrew Parrott, a psychology professor at Swansea University in Wales told the Washington Post.
Parrott has spent years research MDMA’s harmful effects and said he worries the FDA approval could lead many in the public to believe ecstasy is safe for recreational use.
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Researchers have also been exploring other psychedelics to treat mental illnesses like depression and anxiety.
In November 2016, a study published in the Journal of Psychopharmacology claimed that psilocybin (also known as magic mushrooms) relieved anxiety and depression in people with life-threatening cancer.
Scientists have also suggested LSD could be a promising option to treat depression and addiction issues, as the drug leads to increasing optimism, openness, and compassion. Because of this, researchers said the illicit drug could even help battle domestic abuse.
With files from Global News’ Carmen Chai
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