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FDA Approves Phase 3 Clinical Trial of Ecstasy for PTSD Sufferers

Thursday, December 1, 2016 8:04
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The FDA gave permission on November 29 for large-scale, Phase 3 clinical trials of Ecstasy for people suffering with post-traumatic stress disorder, or PTSD. Many people swear the currently-illicit street drug has saved their lives, and if the trial is successful, it would establish Ecstasy as a legitimate prescription drug. [1]

Preliminary trials of Ecstasy, also called MDMA, for PTSD have been successful, but a large-scale trial is necessary before the FDA can approve it. [2]

Multidisciplinary Association for Psychedelic Studies (MAPS), the organization funding the trial involving 230 participants, has in the past studied Ecstasy’s effects on veterans, sexual assault victims, police, and firefighters suffering from PTSD. Said researcher Michael Mithoefer:

“We can sometimes see this kind of remarkable improvement in traditional psychotherapy, but it can take years, if it happens at all. We think it works as a catalyst that speeds the natural healing process.”

Dr. Charles Marmar, the head of psychiatry at New York University’s Langone School of Medicine, agrees that PTSD is tough to beat, so more treatments are needed. He said:

“I’m cautious but hopeful. If they can keep getting good results, it will be of great use. PTSD can be very hard to treat. Our best therapies right now don’t help 30% to 40% of people. We need more options.” [2]

Early Phase 2 Trials

Created in 1985, MAPS is a small nonprofit that advocates for the legal medicinal use of MDMA, LSD, marijuana, and other banned drugs. The organization sponsored 6 Phase 2 studies involving 130 PTSD patients with the stimulant.

Patients, on average, struggled with symptoms for 17 years.

In at least 2 of the trials, participants reported a 56% decrease in severity of symptoms after being administered 3 doses of MDMA under a psychiatrist’s guidance. By the end of the trial, 2/3 of the participants no longer met the criteria for having PTSD. When researchers conducted follow-up exams, they discovered that the participants’ improvements lasted more than a year after therapy.


Source: PTSD Update

The researchers, led by Mithoefer, have applied for breakthrough therapy status with the FDA to speed the approval process. If approved, MDMA could be available by 2021.

The Unfortunate History of Ecstasy

Ecstasy didn’t start out as a party drug.

Its euphoria-inducing effects were first discovered by chemist Alexander Shulgin in the 1970’s. Shulgin distributed the drug – nicknamed Adam – to psychologists he knew who, in turn, started using it in their psychotherapy sessions. MDMA appeared to be useful in treating anxiety disorders, including PTSD, but before a clinical trial could be launched, Adam hit college campuses and dance clubs under the name Ecstasy.

In 1985, the Drug Enforcement Administration (DEA) classified it as a Schedule I drug, meaning it has no medicinal purpose, barring its legal use.

Reservations and Reassurance

The team has proposed to the FDA that MDMA would be used a limited number of times under the guidance of trained psychotherapists as part of a broader course of therapy. This proposal has some in the scientific community worried about the habit-forming nature of the drug.

Andrew Parrott, a psychologist at Swansea University in Wales who has studied the brains of chronic Ecstasy users, said:

“It sends the message that this drug will help you solve your problems, when it often just creates problems. This is a messy drug we know can do damage.”

He warned that giving psychotherapists the authority to administer MDMA could trigger a wave of abuse similar to the opioid crisis.

Research into the effects of Ecstasy on the brain has shown that the drug causes the brain to release a flood of “feel-good” hormones and neurotransmitters that trigger feelings of trust, love, and well-being. MDMA has also been shown in studies to quash fear and negative emotional memories that can rob PTSD sufferers of a good quality of life. Patients say MDMA helped them view past traumas with greater clarity and address their problems.

Ann Mithoefer, Dr. Mithoefer’s wife and a psychiatric nurse, said:

“The medicine allows them to look at things from a different place and reclassify them. Honestly, we don’t have to do much. Each person has an innate ability to heal. We just create the right conditions.”

Those conditions include a comfy futon surrounded by candles, fresh flowers, and soothing music.

Could some PTSD suffers wind up hooked on Molly? Nothing is beyond the realm of possibility, but it seems like a small risk compared to the many stories from former firefighters and servicemen and servicewomen who lost their families, became heavily addicted to opiates, or nearly committed suicide, only to be saved by MDMA.

There are only 2 drugs on the market that are approved to treat PTSD, both of which barely worked better than the placebos in trials. The drugs did nothing for fireman Edward Thompson, who was deeply traumatized by repeatedly having to respond to gory accidents on the job. He turned to benzodiazepines, alcohol, and opioids to cope, but his symptoms only got worse. [3]


The New York Times – Edward Thompson

Thompson said he was in a constant state of panic that no amount of booze or drugs could numb. In 2015, after therapy failed, his wife took his children and left, and he was contemplating jumping in front of a bus. But it only took 3 sessions of MDMA and psychotherapy to help him gain clarity and work through his problems.

He said he has no plans to ever use the drug again. He got what he needed from it and won’t use it “for fun.”

“It gave me my life back, but it wasn’t a party drug. It was a lot of work.”

His wife came back with his kids and said that without MDMA therapy for her husband, “He’d be dead.” [2]

Sources:

[1] The New York Times

[2] New York Post

[3] Gizmodo

Inquisitr

PTSD Update


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