A TREATMENT FOR POST-TRAUMATIC STRESS?
Despite positive results from the study, the legalisation of a widely abused party drug raises a lot of questions, writes DAVE
THE drug known by the street name Ecstasy or Molly could be a promising treatment for posttraumatic stress disorder (PTSD), according to a new study.
Research published Tuesday in the British journal, The Lancet Psychiatry, found that after two sessions of psychotherapy with the party drug, officially known as MDMA, a majority of 26 combat veterans and first-responders with chronic PTSD who had not been helped by traditional methods saw dramatic decreases in symptoms.
The improvements were so dramatic that 68 per cent of the patients no longer met the clinical criteria for PTSD. Patients taking the drug also experienced “drastic” improvements in sleep and became more conscientious, according to the study.
The results, which mirror those of similar, small-scale studies of the illegal drug in recent years, come as MDMA is about to enter larger, Phase 3 trials this summer. Based on previous results, the Food and Drug Administration has given MDMA breakthrough therapy status, which could speed approval. If largescale trials can replicate safety and efficacy results, the drug could be approved for legal use by 2021.
“I was finally able to process all the dark stuff that happened,” Nicholas Blackston, 32, a study participant who had been a Marine machine-gunner in Iraq, said in an interview. “I was able to forgive myself. It was like a clean sweep.”
But, the possible legalisation of a widely abused party drug raises a lot of questions.
No one goes home with a bottle of Ecstasy.
If approved by the FDA, MDMA would only be administered by a licensed therapist. First, a patient goes through three sessions of psychotherapy. In the fourth session, the patient takes a pill. After taking the drug, the patient lies on a futon amid candles and fresh flowers, listening to music. Two therapists — one female, one male — sit at the patient’s side as guides. That session lasts eight hours.
“We encourage them to set aside all expectation and agenda and be open. Experiences tend to be very individual,” said Dr. Michael Mithoefer, one of the principal researchers.
The drug floods the brain with hormones and neurotransmitters that evoke feelings of trust and well-being, users report. Researchers say this allows patients to re-examine traumatic memories.
In follow-up psychotherapy, patients process emotions and insights brought up during the MDMA session. The current protocol calls for patients to take MDMA two or three times, each a month apart, interspersed with psychotherapy.
“The MDMA alone or the therapy alone don’t appear to be as effective,” Mithoefer said. “The MDMA seems to act as a catalyst that allows the healing to happen.”
“I was actually able to forgive myself,” said Nigel McCourry, 36, a Marine veteran who was deployed in 2004 to Fallujah, Iraq, whose experiences mirrored those of three other patients interviewed.
McCourry came home from war unable to escape scenes of an explosion that nearly killed him, and haunted by the memory of two young girls he accidentally killed in a firefight. He struggled to sleep. He drank to forget. Rage eroded most of his relationships.
He tried help at a Veterans Affairs hospital, but could not let his guard down enough to benefit from standard psychotherapy. A handful of medications meant to help left him feeling like a zombie, and he gave them up. He was contemplating
That’s an open question. Large-scale trials, which will include up to 300 participants at 14 sites, may not be able to replicate the success of previous trials, which were limited to a few dozen patients. But so far, results are encouraging. Nearly all patients saw clinically significant reductions in symptoms, and a majority saw such drastic reductions that they no longer met the criteria for a PTSD diagnosis. In the 12 months after MDMA therapy, PTSD symptoms generally continued to decrease.
Side effects, including anxiety, headache, fatigue, muscle tension and insomnia, were generally minor and limited to the days following the MDMA sessions.
Other researchers, intrigued by the results, are starting their own studies of MDMA therapy, including the Department of Veterans Affairs.
Not really, said Dr. John Krystal, who heads the Neurosciences Division at the Department of Veterans Affairs National Center for PTSD. He described the current lack of effective therapy as “a crisis”.
“The problem is that we don’t have many treatments and what we have doesn’t work that well,” he said.
Only about one in three combat veterans with PTSD are effectively treated, he said.
Not big pharma. The research is organised by a small nonprofit called the Multidisciplinary Association for Psychedelic Studies, or MAPS, which was created in 1986 shortly after MDMA was outlawed.
“No one else would touch this, so we had to do it,” said the founder of MAPS, Rick Doblin, who has a doctorate in public policy from Harvard and has made legalising MDMA his life’s work.
The Phase 3 trials are expected to cost US$27 million (RM106.34 million).
... the Food and Drug Administration has given MDMA breakthrough therapy status, which could speed approval. If largescale trials can replicate safety and efficacy results, the drug could be approved for legal use by 2021.
People already are. The National Survey on Drug Use and Health found that in 2014 more than 17 million Americans reported using MDMA. While many are likely doing it purely for recreation, word of the therapeutic uses has spread, and combat veterans are trying it illegally at home.
But, street Ecstasy is dangerous. Doses of the street drug can be an unknown mix of other stimulants and hallucinogens, and an overdose can be fatal. High frequency use of MDMA can also damage the brain.