Summary: ABC News examines research into the effects of using MDMA as an adjunct to psychotherapy. The article highlights how MAPS will move forward with upcoming Phase 3 clinical trials of MDMA-assisted psychotherapy for posttraumatic stress disorder (PTSD). “The ultimate goal is to have MDMA approved as a prescription drug,” reports Alle McMahon of ABC News.
Originally appearing here.
MDMA — more commonly known as ecstasy — is one step closer to becoming a legal form of treatment for post-traumatic stress disorder (PTSD) in the United States.
Researchers have for years been looking at how the drug could be used in conjunction with therapy to help sufferers confront their trauma.
Now the Food and Drug Administration (FDA) has approved it for use in a phase-three clinical trial — the final stage of research required before it can be considered for approval as a prescription drug.
So, what exactly is MDMA, what will the clinical trial involve and what implications might it have for sufferers in Australia?
What is MDMA?
MDMA — or 3,4-methylenedioxymethamphetamine — is a psychoactive drug that reduces inhibitions and causes users to become more alert, affectionate and energetic.
It is the presumed main ingredient in the illicit party drug ecstasy.
Why do researchers believe it can help PTSD?
People with PTSD tend to avoid recollections of the experience that prompted their PTSD or situations that remind them of the trauma.
Exposure therapy is used to treat the disorder because it encourages sufferers to confront their trauma, either by remembering it or re-experiencing the event.
According to the president of Psychedelic Research in Science and Medicine (PRISM), Dr Martin Williams, MDMA can help facilitate that because it is an “empathogen”.
“It promotes a closeness between people, so it makes people feel a lot more open to others, enables them to communicate more effectively and more directly and it also reduces fear and anxiety,” he said. “From that point of view, MDMA is very effective in psychotherapy in opening up the bonds [or] the sense of trust between the patient and the therapist.”
Give me the stats!
The Multidisciplinary Association for Psychedelic Studies (MAPS) was responsible for bringing the case for the phase-three clinical trial to the FDA.
Here’s what it says of its phase-two study results:
- 107 subjects treated with chronic PTSD
- 53 per cent of 74 participants no longer qualified for PTSD after two to three MDMA-assisted psychotherapy sessions
- That compared to 23 per cent who received a placebo
- Of 65 subjects interviewed one year after treatment, 66 per cent no longer had PTSD
How would MDMA be taken?
During a psychotherapy session, pure MDMA would be administered orally via a capsule or dissolved in juice under the supervision of a therapist.
“The therapy session would normally start at 8:00am in the morning and go through to 5:00pm in the afternoon,” Dr Williams said.
“That’s partly due to the fact that the effects of MDMA are reasonably long-lasting, usually last about five or six hours.”
Dr Williams said the patient would sometimes be given eyeshades and music to help them relax.
“Then normally they’d be allowed to just think their own thoughts and discuss with the therapist at any time anything that might be on their mind,” he said.
What are the risks?
Associate Professor Nicole Lee, from the National Drug Research Institute at Curtin University, wrote for The Conversation in April that MDMA could cause nausea, jaw clenching and increased heart rate and blood pressure.
Overdosing on MDMA or mixing it with other drugs such an anti-depressants can also result in serotonin syndrome — too much of the brain chemical serotonin.
Serotonin syndrome can cause agitation, confusion and headache, and in severe cases coma and death.
But Dr Lee said dependence was uncommon.
“Unlike other stimulants, MDMA does not appear to be at high risk of overuse because the positive effects decrease and negative effects increase quickly with use,” she wrote.
It is against the law to use, sell, distribute or manufacture MDMA in Australia.
So why is a phase-three clinical trial a big deal?
Phase-three trials essentially allow for a much larger group of participants to be tested, and the more participants tested, the more conclusive the results.
And what’s the ultimate goal?
The ultimate goal is to have MDMA approved as a prescription drug.
However, Dr Williams stressed it would only be available under supervised treatment.
“As far as I know in the US there is no intention to make it available over a pharmacy counter for people to take away with them,” he said.
So what does this mean for Australia?
It is not clear.
Dr Williams said it was uncertain whether the approval would help fast-track a clinical trial here in Australia, but it could help to change conservative perceptions.
“PRISM has been working for the last five-and-a-half years to try and establish a similar clinical trial, but at this stage we still haven’t succeeded in identifying a research group in Australia that would assist us in getting a trial underway,” he said.
“That seems to reflect the conservatism in Australia. It is very sensitive in terms of funding risks and we feel researchers are concerned about the controversy.
“What we’re hoping is the success in the US will change the landscape over here.”