“Ecstasy can treat trauma patients,” reported The Independent today.
It said that the drug had a ‘dramatic effect’ on people who suffered post-traumatic stress disorder (PTSD) and who did not respond to other treatments. Behind this report is a small randomised controlled trial in 20 people with chronic, treatment-resistant PTSD. The study found that the patients showed some improvement in their symptoms when psychotherapy was combined with MDMA (ecstasy) treatment compared with psychotherapy and placebo. This study has several important limitations and it is far too soon to state that MDMA can be used to treat trauma victims. The trial was in only 20 people who fulfilled very specific criteria (having PTSD on average for 20 years) and who would have found it easy to tell whether they had been given ecstasy or placebo. It only lasted several weeks, and so the long-terms effects are also unknown. More research may follow this initial phase II pilot study, but until then it is difficult to judge the potential of MDMA for treating PTSD. The researchers themselves say it should be considered as a ‘preliminary step’.
Where did the story come from?
The study was carried out by researchers from the Medical University of South Carolina and the Multidisciplinary Association for Psychedelic Studies in California. The study was funded by the Multidisciplinary Association for Psychedelic Studies, an organisation stated to have been involved in the study design, data analysis and write up. The research was published in the peer-reviewed medical journal Journal of Psychopharmacology. The tone of The Independent’s report is very optimistic given the size of this study (12 people receiving treatment, 8 receiving placebo). The newspaper also ought to have stressed the preliminary nature of this research. It is too soon to say that “Ecstasy can treat trauma patients”.
What kind of research was this?
The researchers say that psychotherapies for the treatment of post-traumatic stress disorder (PTSD) are frequently ineffective as patients cannot tolerate the feelings associated with reliving the trauma. They say that a drug that could temporarily reduce fear without inhibiting thought processes or the senses and also keep an “appropriate level of emotional engagement” may help people to begin to engage with psychotherapy. They wanted to determine whether the chemical 3,4 MDMA (ecstasy) could act as a catalyst for psychotherapy after case reports described this use of the chemical as successful before its criminalisation in 1985. In a small randomised controlled trial, they tested the effect of MDMA-enhanced psychotherapy compared with psychotherapy alone (non-drug psychotherapy). A randomised trial is the best way to determine the efficacy of a new treatment, although this one was small (20 people in total), so the findings are less reliable.
What did the research involve?
The researchers enrolled 20 people with post-traumatic stress disorder (PTSD) who had not responded to previous psychotherapy with or without drug treatment and who had had PTSD for about 20 years. The majority were Caucasian females. Those with major medical conditions and borderline personality disorders or current axis I disorder (except anxiety disorder and affective disorder) were excluded, as were people with substance abuse or dependence that had not been in remission for 60 days or more. Patients were randomly allocated to either two sessions of psychotherapy alongside treatment with MDMA or to psychotherapy with placebo. After the second session those in the placebo group were given the opportunity to take the active treatment, but these results were not included in the main analysis. Twelve people were assigned to the MDMA plus psychotherapy group and eight to the placebo plus psychotherapy group. Each person received two experimental sessions structured as follows: an eight-hour experimental session with MDMA or placebo followed by an overnight stay in the clinic, then daily phone contact for a week. The exact content of the sessions depended on the patient, but included quiet introspection and therapeutic discussion. The first dose was given as a pill by mouth and participants reclined and listened to music to begin. Periods of conversation and introspection followed and about two hours later a second dose could be administered at the discretion of the clinician. During the study, the participants were encouraged to abstain from drug treatment (except for quick relief inhalers for asthma). In the six weeks before the study the participants had two 90-minute introductory sessions to prepare for the experiment. They also had a series of non-drug psychotherapy sessions about once a week after receiving their experimental treatments to help them deal with the possible effects of treatment. These were given as and when clinicians felt they were necessary. The study researchers assessed the severity of PTSD symptoms at the beginning of the study, four days after each session and then two months after the second session. They also measured how many people in each group had a demonstrated response to treatment (i.e. more than 30% reduction in severity score since before the treatment was given).
What were the basic results?
The MDMA took effect within 45-75 minutes after the initial dose. Blood pressure, pulse and temperature were higher in those given MDMA, but returned to normal by the end of the sessions. Some adverse effects were reported, including jaw tightness, nausea and dizziness on the day of the sessions and in the week following. No serious effects were reported. Symptoms of PTSD improved over time in both groups but more in those receiving MDMA. In the MDMA group 83% (10 out of 12) responded to treatment compared with 25% (2 out of 8) in the placebo group. In the weeks following the trial, only one additional psychotherapy session was deemed necessary in the placebo group compared with 20 in those receiving MDMA.
How did the researchers interpret the results?
The researchers conclude that “MDMA-assisted psychotherapy can be administered to post-traumatic stress disorder patients without evidence of harm, and it may be useful in patients refractory (resistant) to other treatments.”
This is a small, pilot study. The findings may lead to further research, but it is too soon to state that MDMA can be used to treat trauma victims. Importantly, the researchers note that people who were given MDMA also had far more supplementary psychotherapy sessions.
This has two implications:
- First, it raises the possibility that it was these additional psychotherapy sessions that had an effect on PTSD symptoms and not the MDMA (the researchers say that this is not a likely explanation because a treatment effect was apparent only four days after the first session, i.e. before the participants had been through all the extra sessions).
- Second, the fact that more sessions were needed (the researchers say to “support integration in subjects who experienced anxiety or other difficulties following experimental sessions”) could be interpreted to mean that the MDMA treatment had negative effects. The researchers do not report the difference in side effects between groups beyond the first week after treatment sessions, and so it is difficult to tell whether this could be the case.
This research has several limitations and the researchers say it should be considered only as a preliminary step towards exploring the use of MDMA. These include:
- its small size (it contained only 20 people)
- that it was carried out in a select group of individuals who had had PTSD for an average of 20 years
- that the groups were not balanced at the beginning of the study (those receiving placebo had had more psychotherapy in the past than those receiving MDMA)
- that blinding was easily broken (people could easily tell if they had been given ecstasy or a placebo)
- that the research had a short follow-up More research may follow this initial phase II pilot study, but until then it is difficult to judge the potential of this treatment for PTSD.
Links to the headlines
Ecstasy ‘may help trauma victims’. BBC News, July 19 2010
Ecstasy can treat trauma patients. The Independent, July 19 2010
Links to the science
Mithoefer MC, Wagner MT, Mithoefer AT, et al. The safety and efficacy of ±3,4-methylenedioxymethamphetamine-assisted psychotherapy in subjects with chronic, treatment-resistant posttraumatic stress disorder: the first randomized controlled pilot study. The Journal of Psychopharmacology 2010; published online July 19