AUG 31, 2017 03:10 PM PDT

Ecstasy Given Green Light in PTSD Trial

WRITTEN BY: Xuan Pham

Image credit: Wikipedia.org

The FDA has been making quite a few historic decisions as of late, including the approval of the first gene therapy for the treatment of leukemia. In addition to that, the agency also granted a “Breakthrough Therapy Designation” status for an unlikely compound, MDMA, in the treatment of post-traumatic stress disorder (PTSD). As MDMA is the active ingredient in the recreational drug ecstasy, the decision to move forward with this designation marks a huge milestone for what proponents call a psychotherapy agent.

Post-traumatic stress disorder (PTSD) affects millions of people, but the disorder is notoriously difficult to treat. Even with our best treatment efforts, researchers say a significant portion of patients are still left behind.

Known on the street as “E,” “Molly,” and “millennial aspirin,” MDMA (3,4-Methylenedioxymethamphetamine) is a popular recreational psychedelic drug. The compound acts on the amygdala to induce feelings of euphoria, empathy, and otherwise heightened emotions.

Heavy abuse of the drug – leading to addiction, memory issues, paranoia, and other adverse symptoms – led the FDA to classify it as a Schedule 1 substance and its eventual ban. However, many researchers saw potential in MDMA as a psychotherapy drug, precisely because of how it affects the brain.

In a few early stage clinical trial of MDMA, patients reported working through their trauma in ways that could not be replicated with conventional treatments. One study found a 56 percent decrease in the severity of their PTSD symptoms with the use of MDMA. This shift led more than two-thirds of the patients to free themselves from the diagnosis of PTSD – a remarkable outcome considering the ineffectiveness rate of current therapies. Furthermore, the results seem to have a lasting effect, even after the drug was discontinued.

“The body of evidence that shows MDMA works is so strong and so encouraging,” said Rick Doblin, the founder and executive director of Multidisciplinary Association for Psychedelic Studies (MAPS), which is sponsoring the current Phase III clinical trial, involving over 200 participants.

The FDA usually reserves this designation for drugs that can “treat a serious or life threatening disease or condition.”

"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," according to the MAPS statement.

With this FDA nod, the MAPS association plans to move forward with a Phase 3 clinical trial in 2018 that will focus on “MDMA-assisted psychotherapy.” The success of the third phase of clinical trials is a tremendous milestone before going to market. It is also in this phase that many drug trials fail. However, if successful, MDMA could be on the fast track for approval as a PTSD psychotherapy drug by as early as 2021.

Of note, researchers underscore that the trial is to expand the psychedelic’s medicinal uses, not its recreational potential. So to people who doubt the safety of legal ecstasy, Doblin says: “This is never going to be a take-home drug. It’ll only be prescribed by doctors with special training, for people with specific conditions.”

Additional sources: MAPSLive Science

About the Author
  • I am a human geneticist, passionate about telling stories to make science more engaging and approachable. Find more of my writing at the Hopkins BioMedical Odyssey blog and at TheGeneTwist.com.
You May Also Like
NOV 26, 2018
Cardiology
NOV 26, 2018
Can beet juice 'de-stiffen' the arteries?
If you’ve been drinking beet juice before going to the gym, the results of a new study may surprise you.   Image Credit: "beet juice"...
MAY 31, 2018
Technology
MAY 31, 2018
PUREGRIP: Safe, User-Friendly Bottles for Biomedical Research
Foxx Life Sciences and Borosil Glass Works Joined up to Create a Lab Bottle Breakthrough...
JUN 28, 2018
Cardiology
JUN 28, 2018
"Prehab" Prior to Heart Surgery Boosts Post-Op Recovery
Canadian doctors are promoting the idea of “prehabilitation” for elderly heart disease patients awaiting heart surgery. “Prehab” of...
AUG 11, 2018
Microbiology
AUG 11, 2018
A Microbrewery can Help us Monitor Radiation Exposure
This wearable technology is very sensitive, and can be used by workers that are at risk of radiation exposure....
SEP 15, 2018
Genetics & Genomics
SEP 15, 2018
Data-based Health Management Tool for Aortic Aneurysm
This tool might be extrapolated for many other disorders, and may free patients from repeated doctor visits....
NOV 21, 2018
Cardiology
NOV 21, 2018
What We Know About Kawasaki Disease
Kawasaki disease discovered by Dr. Tomisaku Kawasaki, a Japanese pediatrician, is a rare type of vasculitis, or inflammation of the blood vessels. It&rsquo...
Loading Comments...