MDMA therapy significantly improves symptoms in people with moderate to severe post-traumatic stress disorder compared with placebo, researchers have found.
It is not the first time the positive effect of MDMA has been found in this setting but the significant benefit was ‘particularly notable’ given it was used in a more complex and diverse population than is usually found in clinical trials, the researchers said.
MDMA-assisted therapy sessions were compared with placebo in 104 people with moderate to severe PTSD.
After 18 weeks 71.2% in the MDMA-assisted therapy group no longer met the diagnostic criteria for PTSD compared with 47.6% participants in the therapy-with-placebo group, the researchers reported in Nature Medicine.
It extends the findings from a previous phase 3 trial by the same team which had shown that MDMA therapy was well tolerated and reduced symptom severity and decreased functional impairment in people with the most severe form of the condition.
No deaths or serious adverse events were reported but there were some ‘mostly transient’ side effects including muscle tightness, nausea, decreased appetite and hyperhidrosis.
There were no significant differences in the impact of treatment in those who had more severe PTSD, were at risk of alcohol or substance misuse or had severe adverse childhood experiences.
MDMA is thought to enhance the ability of individuals with PTSD to benefit from psychotherapy by reducing sensations of fear, threat and negative emotions.
Nine people dropped out of the study but eight of those were in the placebo group, which could relate to disappointment with the treatment, the researchers said.
Dr James Rucker, senior clinical lecturer in psychopharmacology and mood disorders at King’s College London, said like the first trial of MDMA therapy for severe PTSD, this latest study shows ‘credible and clinically significant results’ suggesting it is both an effective and relatively safe treatment.
‘However, ethnicity is only one form of diversity and other marginalised groups may be under-represented here, a problem that tends to occur in many clinical trials.’
He added that whilst the growing evidence to support the licensing and wider adoption of MDMA therapy for PTSD was encouraging, the numbers of participants in trials so far are not large enough to detect rarer side effects.
‘In part, this is because MDMA is classified as a Schedule 1 drug, which needlessly drives up the costs of MDMA clinical trials, which in turn reduces the number of participants that can be recruited.’
Professor Neil Greenberg from the Royal College of Psychiatrists said the results of this latest trial had been ‘eagerly awaited’.
‘It is notable that the average duration of PTSD in this study was 16 years and participants had received multiple ineffective treatments in the past.
‘It is also important to recognise that nearly half of the participants had taken MDMA previously before taking part in this trial, which is probably not the case for most people who develop PTSD.’
Yet while it does provide evidence of a potentially beneficial treatment option for those who cannot be helped by more traditional therapies it was unlikely to be the treatment of choice for most patients, he added.
‘The use of MDMA is likely to be tightly controlled, requires two therapists who have been trained in how to deliver psychotherapy for patients who have been given prescribed MDMA who will need to deliver the therapy in a safe, clinical location.’