Why Won’t Australia Run Medical Trials of MDMA?

Vice Australia interviews Martin Williams of Psychedelic Research in Science and Medicine (PRISM) about proposals to conduct research in Australia on the potential benefits of MDMA-assisted psychotherapy to treat posttraumatic stress disorder (PTSD). Williams speaks about the rising rate of PTSD in Australians, how research has provided evidence that MDMA can work as an adjunct to psychotherapy, and the difficulty of conducting psychedelic research in Australia. “MDMA-assisted psychotherapy appears to be one promising alternative to current treatment options that should be available to practitioners,” explains Williams.

Originally appearing here.

If you’ve taken MDMA (usually the active ingredient in ecstasy) you’ll know the euphoria and hugging and evangelical sense of “if everyone tried this, we could save the WORLD.” Well, some people take that evangelism very seriously, or at least in a medical sense. Last year VICE reported on trials that were about to start in Canada to test MDMA on people suffering Post Traumatic Stress Disorder (PTSD), and while trials in other parts of the world have been undertaken or are underway, Australia has so far refused to get involved. To find out why, I spoke to Martin Williams from Psychedelic Research in Science & Medicine (prism.org.au), an Australian organisation trying to run the first such local trial, and asked him why we need to reframe the ecstatic experience in Australia.

VICE: Hi Martin, so what’s the connection between MDMA and PTSD treatment?

Martin Williams: So the first MDMA/PTSD clinical trial was started in Madrid in 2000, treating female victims of sexual assault, but it was interrupted through the intervention of the Madrid Anti-Drug Authority after the treatment of only six participants. The preliminary results were positive, paving the way for further investigation. The first trial to be completed was conducted by Michael and Annie Mithoefer in South Carolina in 2001. The results of this trial, which mainly treated victims of sexual assault and childhood sexual abuse, indicated that MDMA-assisted psychotherapy was significantly more effective than psychotherapy alone in providing relief from symptoms of PTSD. The second completed trial took place in Switzerland: other studies are now underway in Vancouver and Tel Aviv, but there are no results at this stage.

What happens during MDMA-assisted therapy?

Therapy entails administration of the main dose or placebo at around 8 am. The participant is given a comfortable sofa/bed to lie on, self-selected music, and eyeshades which may be worn or removed. As the peak effects of the MDMA are being felt, a booster dose of ½ the original dose (or placebo) is offered. Invariably, the participant undergoes a significant psychological process or journey. The total session normally lasts about 8 hours, during which the participant’s physical condition is checked periodically and some tests are performed. The participant remains in the room overnight and leaves the following morning after a 1-2 hour follow-up integration session with the therapists.

Why do trials need to be run in Australia? Is there something specific that Australia might bring to the table?

Despite our supposedly relaxed, laid-back lifestyle, PTSD is as prevalent in Australia as it is in other Western societies. In recent decades our armed forces have been involved in military action in many corners of the globe; natural disasters have taken their toll on emergency personnel and members of the community, and trauma, violence and sexual assault are everyday occurrences in our society. Many of these cases are resistant to standard treatment modalities. MDMA-assisted psychotherapy appears to be one promising alternative to current treatment options that should be available to practitioners. For MDMA to be classified as a prescription drug in Australia, which we are hoping to achieve in due course, the Therapeutic Goods Administration generally requires clinical trials to be conducted.

What kind of responses do you get from people when they hear about MDMA trials in Australia?

Most people who are familiar with MDMA’s psychological effects recognise its potential to help in the treatment of PTSD, along with anxiety and interpersonal problems such as relationship issues. Even people who have not experienced MDMA (including my mum!) can see that PTSD is a growing problem that is not always successfully managed by current approaches. Predictably, the more conservative folk among us are less forthcoming with their support, usually reciting the “Drugs are Bad” mantra or opining that it will be impossible to change the legal status of MDMA. However, I’m happy to say I’ve never met with a hostile response.

Is it hard finding the right investigators for such a trial?

The Australian academic research system is based almost entirely on public funding, and aversion to the risk of funding cuts or denial of promotion is a very significant factor. The risk in this case is being associated with a study that might investigate the benefits of a drug that many research projects have been designed to show causes harm, and we suspect many researchers are not prepared to take such a risk. Another factor is that extensive PTSD research has already been conducted within other treatment paradigms, and researchers tend to become set in their ways and consequently resistant to alternatives that might challenge their established programs.

How do you gets ethics clearance to work with compounds that are ostensibly illegal?

Surprisingly, it appears that the current legal status of MDMA as a Schedule 9 drug is not likely to be a direct factor in obtaining ethics approval for a clinical trial. While there is still some debate about its safety profile in all contexts, especially associated with recreational use, enough studies have established that it is safe at moderate doses in healthy individuals that this should not prevent ethics approval.

As an independent organisation, how does PRISM fund its activities?

PRISM is a non-profit association that is recognised by the ATO as a health-promotion charity. This enables donations to PRISM from individuals and businesses to be tax deductible. We’ve been fortunate to attract donations from some generous individuals already, and we look forward to continued community support. Once we commence clinical trials, we will have much greater need for funding. At that point, in addition to private donations and some partner contributions from MAPS, we’ll be seeking institutional and public funding through the established channels.

Assuming PRISM establishes trials in Australia, what comes next for MDMA research, or other compounds that are largely sidelined by mainstream science?

There’s a range of research projects we’re hoping to initiate in Australia, all exploring novel alternatives to established approaches for the treatment of serious complaints such as addiction, anxiety and depression. Research is already underway into the use of LSD and psilocybin in the treatment of anxiety and addiction; another natural product called ibogaine is also being investigated for addiction. The first-line anaesthetic Ketamine is showing great promise in the treatment of intractable depression. PRISM has all of these compounds, and several others, in its sights as candidates for clinical research in the future.