Based on promising results from its preliminary trials, the Food and Drug Administration (F.D.A.) reportedly gave the green light on Tuesday to a large scale Phase 3 clinical trial for using Ecstasy as a prescription drug to treat PTSD. The trial would be the final stage before approving the drug’s legal use.
The F.D.A declined to comment on any of its trials, citing regulations that prohibit divulging information regarding the drugs and tests being run, according to The New York Times. However, there has always been an interest in the medicinal traits of banned drugs. The small nonprofit organization known as the Multidisciplinary Association for Psychedelic Studies originally looked into the legal medical use of drugs such as Ecstasy, LSD, and marijuana from the time of its establishment in 1985, according to the Times. The nonprofit sponsored Phase 2 studies for treating PTSD on a reported 130 patients, and funded the research for Phase 3 of the F.D.A. tests, which is said to include a total of 230 patients.
Previous trials were held in Charleston and focused on treating veterans, sexual assault victims, and policemen and firefighters who had PTSD for at least 17 years. The patients sought the new treatment after not responding to traditional psychotherapy. After merely three doses administered in a controlled space, the patients’ symptoms reportedly decreased by an average 56 percent, according to a study logged by the Journal of Psychopharmacology. By the end of the study, two-third of the patients reportedly no longer met the criteria for having PTSD.
Researchers are reportedly very “optimistic” about the trials, and have pushed for the F.D.A. to speed up the approval process. “I’m cautious but hopeful,” Dr. Charles R. Marmar, a leading PTSD researcher and head of psychiatry at New York University’s Langone School of Medicine, said. Marmar was not involved in the initial study. “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 percent of people. So we need more options.”
While there definitely seems to be benefits to the use of ecstasy, there is still a fear of people abusing the privilege. “It sends the message that this drug will help you solve your problems, when often it just creates problems,” psychologist at Swansea University in Wales, Andrew Parrott said. “This is a messy drug we know can do damage.” In order to account for this setback, the approval for the drug use would be limited to a certain number of times used by a patient and would only be administered by a trained psychotherapist, the Times reports.
The F.D.A. did not disclose when or how long the phase 3 trial would take. But if it is approved, Ecstasy could be hitting a pharmacy or drug store near you by 2021.
source: complex.com BY JESSICA MCKINNEY