So you might have heard recently about some big news with MDMA getting an approval from the FDA. Well this doesn’t mean that Molly is now street legal but there has been a big change in the FDA’s stance towards MDMA. Before we dive into the announcement its important to understand the background.
What MAPS is and the research their doing
The party at the centre of this story is the Multidisciplinary Association for Psychedelic Studies also known as MAPS. They're a not for profit organization founded in 1986. Their goal is to develop “medical, legal, and cultural contexts for people to benefit from the careful uses of psychedelics and marijuana.” [http://www.maps.org/about] Basically, they are doing the research, outreach and education to spread the word that psychedelics aren’t evil and might actually be able to help us out a lot.
MAPS was founded by Rick Doblin, a PhD holding researcher who has been involved in numerous long term studies on medicinal uses of psychedelics and marijuana. His personal goal is to be the first licensed psychedelic therapist and his long term goal is to bring psychedelics out of the realm of illegality and back into the use of medicinal and therapeutic uses.
Doblin’s fight to use psychedelics began in the mid-70s, MDMA was a fresh discovery and was being used by therapists as a therapeutic tool under the code name “Adam”. Then in 1985, the Drug Enforcement Administration went against the Administrative Law Judge handling the hearing on MDMA and declared it a schedule 1 drug. This ruling meant that the DEA believed MDMA to have a high potential for abuse and that the there was no accepted medical use. The ruling made it near impossible to legally use MDMA for research or therapy.
Doblin and MAPS have been continuing their fight since that judgement to obtain various approvals from government agencies (FDA, DEA) to be able to conduct research on psychedelics. They have made their current focus MDMA research and have recently made some major progress.
Rick Doblin
Who can benefit from this research?
MAPS primary focus in recent years has been the study of MDMA-assisted psychotherapy. This novel style of therapy can help anyone suffering from psychological and/or emotional damage. This includes victims of sexual assault, violence or any type of trauma. In addition it may be of use for autistic adults dealing with social anxiety and for treating anxiety in end of life patients.
MDMA-assisted psychotherapy is highly effective and fact acting treatment. The MDMA used in research is quite different from that found on the streets. It has been created in a lab setting and “has been proven sufficiently safe for human consumption when taken a limited number of times in moderate doses.”[http://www.maps.org/research/mdma] It is then administered a few times during the course of specific psychotherapy sessions and often shows results in weeks.
Current alternatives therapies involve prescriptions which are usually taken daily for years and in some cases for the rest of a patients life. Basically, MAPS is proposing a therapy that could save hundreds of thousands of people from excessive expenses, extreme side effects and significant time and suffering spent dealing with their trauma. Their mission is extremely important and urgent as currently there are millions of people struggling through the horrible the effects of dealing with these traumas. Unfortunately, in the interim many people take their own lives after becoming frustrated with the ineffectiveness of current treatments, it is MAPS hope that the speed and long-term efficacy of this new treatment could literally save lives. So now lets get back to the story in the news.
What is happening with MAPS now?
Last week MAPS released a major press statement announcing that after years of lobbying, the FDA has finally granted the Breakthrough Therapy Designation for MDMA-assisted psychotherapy for the treatment of Post Traumatic Stress Disorder (PTSD). In the press release MAPS stated that by “granting Breakthrough Therapy Designation, the FDA has agreed that this treatment may have a meaningful advantage and greater compliance over available medications for PTSD.” [http://www.maps.org/news/media/6786-press-release-fda-grants-breakthrough-therapy-designation-for-mdma-assisted-psychotherapy-for-ptsd,-agrees-on-special-protocol-assessment-for-phase-3-trials]
The FDA is allowing MAPS to go ahead with Phase 3 trials, which will assess the efficacy and safety of MDMA-assisted psychotherapy in 200-300 participants with PTSD in the U.S., Canada, and Israel. Participants will receive three day-long sessions of psychotherapy over a 12-week treatment period with either MDMA or a placebo, along with 12 associated 90-minute non-drug preparatory and integration sessions. The patients will be assessed at the end of the trials by a neutral third party. The previous phase 2 trials were extremely successful. 68% of phase 2 trial participants were PTSD symptom free after a 12-month treatment. Amazingly, 61% of participants had experienced full recovery after only two months of treatment. These larger phase 3 trials will likely vindicate the healing potential of psychedelics. The hope is that the acceptance of psychedelics as a valid medical and therapeutic tool may, in turn, lead to a wider societal acceptance of psychedelics.
Legalization follows medicalization
MAPS founder Rick Doblin has been adamant that "legalization follows medicalization."
Doblin believes that all psychedelics can follow the path of marijuana. “As we have observed with marijuana, support for legalization follows medicalization. It is my hope that this trend will replicate with MDMA and other psychoactive substances.” Essentially once the use of a drug becomes a medical treatment Doblin believes it will help reduce stigmas, which is the first domino to fall in the eventual wider acceptance of the drug. Doblin founded MAPS with the mission of allowing for the medical use of psychedelics, which would eventually lead to their broader acceptance and eventual legalization.
In Doblin’s view, “when used carefully and thoughtfully, psychedelics have incredible potential to unlock profound healing for individuals, which in turn, drives social change; psychedelics, especially in therapeutic and spiritual contexts, can facilitate transformative inner awareness. Psychedelics inspire insightful and expansive states of reflection, as well as feelings of compassion, hope and a “connectedness” or “oneness” with all forms of life.”
This new position by the FDA is undoubtedly groundbreaking but it will still be a while before pure MDMA is available at your local store (legally). Nevertheless the medicalization of MDMA is an important and necessary step in the evolution of our societies relationship with psychedelics. For more on Rick Doblin and his crusade to vindicate psychedelics listen in to the Vancouver Real episode Below or listen to the full episode on iTunes or Stitcher Radio.
