The FDA Has Approved New Trials for the Use of Ecstasy for PTSD Patients
The Food and Drug Administration (FDA) gave the go-ahead Tuesday for large-scale clinical trials of MDMA for the treatment of posttraumatic stress disorder.
MDMA — better known as Ecstasy — will be part of phase 3 clinical trials, a final step before the party drug is potentially approved as a prescription drug for the treatment of PTSD, the New York Times reports. If approved, Ecstasy could become a prescription drug by 2021.
FDA spokesperson Sandy Walsh tells Yahoo Beauty that the FDA can’t speculate on how likely any product or drug is to be approved by the agency. “Products have to meet the FDA’s standards for efficacy and safety and go through our drug approval process,” she says. The FDA also can’t currently comment on why Ecstasy is being studied due to federal law and FDA regulations, she says. However, she points out, schedule I substances (a class of drugs that includes Ecstasy), “are subject to the most stringent restrictions under the Controlled Substances Act and may not, under the express provisions of the CSA, lawfully be manufactured, distributed, dispensed, or possessed except as part of a research protocol that is approved by FDA, registered with Drug Enforcement Administration (DEA), and subject to record-keeping and storage rules.” However, these drugs can be researched under certain restrictions.
The idea of using of Ecstasy to treat PTSD didn’t come out of the blue. One study published in the Journal of Psychopharmacology in 2012 found that patients given three doses of Ecstasy under a psychiatrist’s care reported a 56 percent decrease in the severity of their symptoms on average. And at the end of the study, two-thirds of patients no longer met the criteria for having PTSD.
According to the National Center for PTSD, the condition is a mental health problem that some people develop after experiencing or witnessing a life-threatening event, such as combat, a natural disaster, a car accident, or sexual assault. Symptoms vary but can include reliving the event through flashbacks (or nightmares), avoiding situations that remind a patient of the traumatic event, and feeling on edge. There is also a link between PTSD and suicide, according to the U.S. Department of Veterans Affairs, although the correlation is “not entirely clear.”
An estimated 8 percent of the population will have PTSD at some point in their lives, and about 8 million people suffer from the condition each year, the National Center for PTSD says.
Psychiatrist Gail Saltz, MD, host of “The Power of Different” podcast, tells Yahoo Beauty that there are cases in which Ecstasy has been shown to be successful in accelerating the beneficial effects of psychotherapy for PTSD, even when other treatments have failed. However, she points out, these cases are anecdotal, so phase 3 trials of the drug are needed.
“The therapeutic use of MDMA to help with PTSD is encouraging,” licensed clinical psychologist Alicia H. Clark, Psy.D., tells Yahoo Beauty. “Its capacity to produce feelings of calm, love, and safety appears to allow PTSD sufferers (in a therapeutic setting) to re-experience their trauma through a lens devoid of anxiety.” Clark likens MDMA to hypnosis or progressive densitization, allowing patients to actively pair their traumatic memories with feelings of calm, love, and safety, laying down new associations and pathways that help them remember their experiences more positively.
“This is powerful and appears to trigger associations that are lasting in the patients who have tried the treatment,” Clark says. “So much of therapeutic progress is about changing one’s perspective and outlook, and this new therapy appears to jumpstart this with a population in great need.”
“I believe we have to go to the ‘root’ of the disorder, which is why ecstasy may prove helpful,” Mike Dow, Psy.D., psychotherapist and author of The Brain Fog Fix, tells Yahoo Beauty. “It may allows us to use exposure therapy, a type of cognitive behavioral therapy, in a more effective way.” Many patients with PTSD drop out of traditional exposure therapy because it takes a long time and involves recounting horrific events 10, 20, or 50 times, he says, adding, “if ecstasy combined with therapy that helps reprocessing trauma (what they’ve done in the most recent studies) can help treat PTSD, it’s worth the risk.”
Saltz says Ecstasy may be effective in treating PTSD because the drug affects dopamine and serotonin production systems in the brain, leaving a patient with positive feelings, and a sense of warmth and trust with others, the latter of which is important in allowing a therapist to guide patients in therapy. It can also help patients have a different perspective, allowing them to reprocess the traumatic event, and it may help them have a change in perception, which also enhances understanding and reprocessing of the traumatic memory.
However, Saltz points out that Ecstasy can be addictive. “Anything that effects dopamine systems can be addictive,” she says. “It feels good, so it is easily abused.” Ecstasy can also cause brain damage if used in an ongoing manner, she says, and even in the short term, the use of Ecstasy for days can cause depression, irritability, and sleeplessness.
Clark points out that the abuse potential with ecstasy is high. “It is important to note, however, that the drug’s reported success is under the direct supervision and guidance of a skilled clinician to facilitate healing,” she says. “Using MDMA recreationally and without clinical supervision, while tempting to sufferers already prone to substance abuse, would not likely produce the desired results.”
James J. Galligan, Ph.D., a professor of pharmacology and toxicology and director of the neuroscience program at Michigan State University, tells Yahoo Beauty that ecstasy isn’t an addictive drug in the way that heroin, cocaine, or even alcohol is. “People do like to use it, but it doesn’t work on the brain in the same way that other highly addictive drugs work,” he says.
Currently, PTSD patients are treated with several methods, including cognitive behavioral therapy (in which a therapist helps people change the way they think about and approach a trauma), exposure therapy (which attempts to desensitize a patient to the trauma), group therapy, and medications, such as anti-depressants, the U.S. Department of Veterans Affairs reports.
Despite the concerns about the use of Ecstasy as a PTSD treatment, Saltz says current treatment options only work for about 60 to 70 percent of patients. “Many are untreated, and it can make them unable to function in their work and in relationships,” she says. “New treatments are needed.”
Ecstasy may be a solution, she says — we just need to learn how to control its use. “If Ecstasy can actually help the nonresponders to stay in and benefit from the psychotherapy, that would be very worthwhile,” she says. “Then we as a society and as a medical profession will have to figure out how to manage the potential for abuse.”
Clark agrees. “More therapies and treatment methods are sorely needed, and MDMA, if shown to be safe and effective, could provide needed relief to veterans and trauma survivors who are suffering and fighting to reclaim their lives,” she says.
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