pharmafileMay 04, 2018
Tag: Recreational drug , MDMA , PTSD symptoms
Promising new findings have been revealed in the efficacy of MDMA in treating post-traumatic stress disorder (PTSD).
The FDA-approved trial, sponsored by the Multidisciplinary Association for Psychedelic Studies, observed the effects of 3.4-methylenedioxymethamphetamine in 26 participants with PTSD lasting longer than six months and for which they had received prior treatment: 22 veterans, three firefights and a police officer. Each were given a course of treatment including 13 hours of non-drug psychotherapy sessions in addition to two eight-hour sessions were they were administered with a randomised oral dose of 30, 75 or 125mg of MDMA, a drug which has been illegal in the US since 1985.
It was found that 68% of patients receiving either of the two highest doses were no longer qualified as suffering from PTSD one month after the second MDMA-assisted session. 29% of patients in the lower dose group achieved the same. One year after treatment, an overall 67% no longer qualified for a PTSD diagnosis, while those who still did qualify saw a reduction in their symptoms.
Side-effects of the drug’s use were minor and included anxiety, headache, fatigue and muscle tension. One patient experienced premature ventricular contractions, but fully recovered after an overnight hospital stay. Four serious adverse events were reported, including suicidal ideation, appendicitis and major depression, though three of these were determined to be unrelated to use of MDMA.
PTSD affects around eight million people in the US every year, presenting symptoms such as flashbacks and distressing thoughts which can present a greater risk of unemployment, substance abuse and suicide. Currently, treatments for the condition include forms of psychotherapy such as cognitive processing therapy or exposure therapy, alongside prescription drugs such as antidepressants. The success of these methods are highly lacking however, with as much as 72% of veterans retaining their PTSD diagnosis after receiving them. "Development of new treatments should address the common reasons for treatment avoidance, failure, and dropout," argued Dr Michael C Mithoefer, lead author of the study and a psychiatrist in the Department of Psychiatry and Behavioral sciences at the Medical University of South Carolina.
"At least one in two PTSD patients cannot tolerate or do not respond adequately to existing treatments, so there is an urgent need for better treatments for the millions of military veterans and others with PTSD," commented Ann Mithoefer, one of the lead researchers on the trial. "These results are further evidence that MDMA, used just two times at monthly intervals, can make psychotherapy much more effective and better tolerated. I'm excited that Phase 3 trials will soon confirm whether this therapy can be approved for widespread use in a few years."
The findings could have huge implications as estimations by the Multidisciplinary Association for Psychadelic Studies (MAPS) pen a possible final FDA approval of the drug’s use to arrive by 2021.
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