FDA’s OK on trial opens possibility of prescription ecstasy in five years
The Food and Drug Administration on Tuesday approved the first large-scale, phase 3 clinical trial of ecstasy in patients suffering from post-traumatic stress disorder (PTSD), the New York Times reported.
The regulatory green-light follows six smaller-scale trials that showed remarkable success using the drug. In fact, some of the 130 PTSD patients involved in those trials say ecstasy—or 3,4-Methylenedioxymethamphetamine (MDMA)—saved them from the devastating impacts of PTSD after more than a decade of seeing no improvement with the other treatment options available.
Currently, the best of those established treatment options can only improve symptoms in 60 to 70 percent of PTSD patients, one expert noted. However, after one of the early MDMA studies, the drug had completely erased all traces of symptoms in two-thirds of PTSD patients.
“It changed my life,” C. J. Hardin, a participant in one of the trials, told the Times. Hardin, 37, suffered with PTSD after returning home from three military tours in Iraq and Afghanistan, and the illness left him divorced, an alcoholic, and suicidal. He tried therapy programs and several medications before enrolling in the MDMA study. He’s now working as an airplane mechanic and going to college. “It allowed me to see my trauma without fear or hesitation and finally process things and move forward,” he said.
The new Phase 3 trial will involve at least 230 patients and is planned to start in 2017. Like the other trials, it is backed by the Multidisciplinary Association for Psychedelic Studies (MAPS), a nonprofit created in 1985 to advocate for the medical benefits and use of psychedelic drugs, such as MDMA and marijuana.
Also like the others, the new, larger trial will involve a limited number of MDMA treatments administered by professional psychotherapists as part of a therapy program.
In previous trials, patients spent 12 weeks in a psychotherapy program, including three eight-hour sessions in which they took MDMA and talked through traumatic memories.
“The medicine allows them to look at things from a different place and reclassify them,” said Ann Mithoefer, a psychiatric nurse who conduced some of the early trials with her husband, Michael C. Mithoefer, a psychiatrist. “Honestly, we don’t have to do much. Each person has an innate ability to heal. We just create the right conditions.”
The Mithoefers and their colleagues through MAPS have applied for a speedy approval process through the FDA, allowed for therapies that could be “breakthroughs.” If everything goes as they plan, MDMA could be available as a prescription medication by 2021.
Previous research found that MDMA spurs the release of hormones and neurotransmitters in the brain, such as norepinephrine, dopamine, and serotonin, which increase heart rate and energy and produce a sense of euphoria, emotional closeness, and trust. In the 1970s, researchers believed it to be a promising drug to treat psychiatric disorders. However, as recreational use became more popular and instances of abuse rose, the Drug Enforcement Administration listed MDMA as a Schedule I drug in 1985, making it illegal and labeling it as having no accepted medical uses.
That potential for abuse has some researchers concerned, despite the new promising trials. “It sends the message that this drug will help you solve your problems, when often it just creates problems,” Andrew Parrott, a psychologist at Swansea University in Wales who has studied the brains of chronic ecstasy users, told the Times. “This is a messy drug we know can do damage.”
Published at Thu, 01 Dec 2016 00:06:30 +0000
|
|
The post FDA’s OK on trial opens possibility of prescription ecstasy in five years appeared first on Daily Rant Online.
from Daily Rant Online http://ift.tt/2gMQ1uU
via IFTTT
Comments
Post a Comment