12.01.2016
wellness

FDA Okays Testing Ecstasy as a PTSD Cure; Don’t Try It on Your Own

Hope is on the far horizon.

The Food and Drug Administration has given its blessing to large-scale Phase 3 clinical trials testing MDMA therapy as a treatment for Post Traumatic Stress Disorder (PTSD).

Drugs are fantastic and have improved the lot of mankind in countless quantifiable and irrefutable ways. Also, drugs are implicated in heroin epidemics, cocaine hubris, and amphetamine psychosis. It’s not necessarily that there are good drugs versus bad drugs. It’s more that some drugs, entire classifications of them in fact, can be used either for good or to have the fuck abused out of them.

MDMA, known in the neighborhood as ecstasy or Molly, belongs to that class of dual-purpose drugs that can be harmful or helpful, depending upon use case scenarios. The Drug Enforcement Administration of the United States rates many of the world’s known good-bad drugs as Schedule 1 controlled substances. This labeling classifies these chemicals as having no medicinal value, which severely hampers scientific research into their positive attributes.

The upcoming tests of MDMA for PTSD treatment will be conducted by the Multidisciplinary Association for Psychedelic Studies (MAPS), which may sound like an academic extension of Pee-wee’s Playhouse. Actually, MAPS is a nonprofit research group formed in 1986 to explore and legitimize “medical, legal, and cultural contexts for people to benefit from the careful uses of ” psychoactive substances such as LSD, marijuana, MDMA, ibogaine, ayahuasca, and derivatives from so-called magic mushrooms.

If the mental-health healing community is seen to embrace MDMA, potential drug abusers will conclude that dosing on Molly and driving while babysitting is entirely okay. 

MAPS funded the preliminary studies of an MDMA role in PTSD treatment that set up FDA approvals for the Phase 3 research. MAPS’s six Phase 2 studies involved 130 PTSD patients. The new round of clinical trials is expected to include 230 or more subjects.

The early stage results, obviously, have been promising, so promising that the Drug Enforcement Administration has not stepped in to kibosh the project.

From the New York Times:

Two trials here in Charleston focused on treating combat veterans, sexual assault victims, and police and firefighters with PTSD who had not responded to traditional prescription drugs or psychotherapy. Patients had, on average, struggled with symptoms for 17 years.
After three doses of MDMA administered under a psychiatrist’s guidance, the patients reported a 56 percent decrease of severity of symptoms on average, one study found. By the end of the study, two-thirds no longer met the criteria for having PTSD. Follow-up examinations found that improvements lasted more than a year after therapy.

These positive initial findings have met pockets of healthy skepticism, with good reason (as any responsible adult who has ever nursed a Molly-addled middle-aged rave child back to objective life on this planet can attest). A concern has been voiced that if the mental-health healing community is seen to embrace MDMA, potential drug abusers will conclude that dosing on Molly and driving while babysitting is entirely okay. 

Also from the New York Times:

“It sends the message that this drug will help you solve your problems, when often it just creates problems,” said Andrew Parrott, a psychologist at Swansea University in Wales who has studied the brains of chronic Ecstasy users. “This is a messy drug we know can do damage.”
Allowing doctors to administer the drug to treat a disorder, he warned, could inadvertently lead to a wave of abuse similar to the current opioid crisis.

To Dr. Parrott’s point, the current opioid crisis, in the view of current U.S. Attorney General Loretta Lynch, is the result of doctor prescribed medications. However, contrary to the profligate distribution and self-administration of pharmaceutical narcotics in the U.S. for pain management, MDMA’s role in treating PTSD consists of only three dosages of the drug, administered in the presence of mental health professionals. 

PTSD is a debilitating condition loaded with tragic outcomes. It has baffled medical responders for decades. The most-successful treatments yet devised by psychiatric protocols and FDA-approved pharmaceuticals leave 30 to 40 percent of patients feeling just as bad as when they started, according to estimates of Dr. Charles R. Marmar, the head of psychiatry at New York University’s Langone School of Medicine.

PTSD sufferers should be cautioned: Do not attempt to self medicate with MDMA. 

Perhaps it is time to give ecstasy a chance. Obviously, the FDA heard a strong argument, or approval would have been withheld. Still, individual PTSD sufferers should be cautioned: Do not attempt to self medicate with MDMA. The studies conducted by MAPS place patients in the context of a 12-week course of psychotherapy. Only three therapy sessions within those 12 weeks occur with the aid of MDMA.

In follow-up interviews, some patients revealed that the MDMA sessions had eliminated a PTSD diagnosis and had also helped curtail abuse of alcohol and other drugs. However, any person currently addressing PTSD symptoms with booze, weed, and/or pills, with no professional guidance, is unlikely to experience a positive change simply by adding MDMA to the mix.

If you are hurting, keep hanging on and take advantage of whatever help is available. The MDMA researchers are pushing for “breakthrough therapy status,” which would fast track the therapy. Even with a sped-up route, don’t expect anti-PTSD ecstasy treatment to be approved before 2021.

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