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An effort to get Ecstasy FDA-approved is moving right along

From Tech Insider:

After veteran Tony Macie came back from Iraq in 2007, he was diagnosed with post traumatic stress disorder (PTSD).

Macie went to the VA "on and off" and tried the standard therapy.

"And then I kind of just fell off the radar, secluded, and did my own thing and got really dependent on a lot of the meds," Macie explains in a video by the Multidisciplinary Association for Psychedelic Studies (MAPS).

The retired sergeant then became part of a clinical trial organized by MAPS that was testing an unusual substance in an attempt to heal people with who hadn't responded to traditional therapies for PTSD.

That substance, MDMA (commonly referred to as "Molly"), is the pure form of the illegal party drug known as ecstasy. (Most non-research substances that are sold as ecstasy or Molly are not actually pure MDMA and can be significantly more dangerous.) The trial pairs MDMA with psychotherapy.

One of the early studies conducted by MAPS showed that 83% of the study participants no longer showed signs of PTSD two months after treatment, and long-term follow-ups conducted an average of four years later showed that most of those benefits stuck.

Though small and preliminary, the results were encouraging enough to help lead to Phase 2 clinical trials — the second in the three sets of human trials required before the Food and Drug Administration (FDA) will consider a new drug for approval.

"Phase 3 starts around 2017, and it will take four to five years to finish. So that will put it at early 2021 for FDA approval."

Posted: 3/31/2016 3:26:00 PM

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Fast morphine treatment may prevent PTSD

From msnbc.com:

Quickly giving morphine to wounded troops cuts in half the chance they will develop post-traumatic stress disorder, according to a provocative study that suggests a new strategy for preventing the psychological fallout of war.

Researchers at the U.S. Naval Health Research Center led the study of about 700 troops injured in Iraq from 2004 through 2006.

About 53,000 troops returning from Iraq and Afghanistan have been treated for PTSD, a disorder in which someone who has endured a traumatic event keeps re-experiencing it and the fear it caused. Patients often have trouble with work, relationships, substance abuse and physical ailments.

Researchers have been testing ways to treat it, and the new study looked at whether fast and strong pain relief can help prevent it.

It was unclear whether it was the fast pain treatment or something specific to morphine that made the difference.

But researchers theorize that simply easing pain might reduce the severity of the psychological trauma, or that prompt relief might alter the way the brain remembers the attack or injury — in essence, causing the mind to file away the episode as less traumatic.

Troops in the study initially were treated at military medical facilities in Iraq, mainly for wounds caused by roadside bombs, bullets, grenades or mortar fire. A few dozen had burns or were hurt in crashes or falls. The decision on whether to give morphine was up to the individual doctor, based on the patient’s condition.

Of the 696 troops in the study, 493 — about 70 percent — were given morphine, most within an hour of injury. Two years later, 147 of them had developed PTSD. Of the 203 not given morphine early on, 96 developed PTSD.

That worked out to a 53 percent lower risk of developing PTSD for those treated early with morphine. No other factor, such as the nature or severity of injuries, had much effect on the chances of developing PTSD, Holbrook said.

“These are provocative and thought-provoking findings that should lead scientists to investigate the underlying mechanisms” in future studies, said JoAnn Difede, a PTSD researcher at New York-Presbyterian/Weill Cornell Medical Center.

Posted: 1/14/2010 12:02:00 PM

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Study: Ecstasy may help treat PTSD

From MarketWatch:

Ecstasy may help sufferers of post-traumatic stress disorder learn to deal with their memories more effectively, researchers in Norway suggest.

"A goal during exposure therapy for PTSD is to recall distressing experiences while at the same time remaining grounded in the present," study authors Pal-Orjan Johansen and Teri Krebs, based at the Norwegian University of Science and Technology said in a statement. "Emotional avoidance is the most common obstacle in exposure therapy for PTSD, and high within-session emotional engagement predicts better outcome."

Psychiatrists who have administered MDMA -- the pharmaceutical version of Ecstasy -- to anxiety patients have noted it promotes emotional engagement; strengthens the bond between the patient and doctor; decreases emotional avoidance and improves tolerance for recall and processing of painful memories.

Johansen and Krebs suggest there are three possible biological reasons for why ecstasy could help individuals with PSTD -- ecstasy is known to increase the release of the hormone oxytocin, which is involved in trust, empathy and social closeness. It also acts in two brain regions to inhibit the automatic fear response and increase emotional control and thirdly, ecstasy increases the release of two other hormones, noradrenaline and cortisol, essential to triggering emotional learning, including the process that leads to fear extinction, on which therapy for PTSD relies.

The findings are published in Journal of Psychopharmacology.
Posted: 3/10/2009 4:05:00 PM

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