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Not long ago, the idea of walking up to a clerk behind a counter and getting a baggie of weed seemed ludicrous. Are psychedelics next? But in truth, psychedelics will probably never be available by prescription at your corner pharmacy—if they even make it to the commercial market at all. This umbrella categorization includes everything from marijuana to ketamine. MDMA, in contrast, causes the brain to release its own stores of serotonin to promote feelings of empathy , euphoria, and love. These are the drugs that have most intrigued psychiatrists with their potential therapeutic value. Image: Warehouse party via Flickr. When these drugs were first discovered, psychologists of the 60s LSD and 70s MDMA were quick to note and document their usefulness in conjunction with psychotherapy. But with the proliferation of these same drugs on the street and in clubs, the Drug Enforcement Agency was quick to list them as schedule 1 : substances with a high potential for abuse and no legitimate medical value. In his early career, Doblin dodged the draft for the Vietnam War and decided to devote his life to the study of psychedelics instead. Over time, Doblin managed to start MAPS, get funding, and begin the long and arduous process of developing a new medical drug. Clinical trials happen in three phases. The first phase tests safety, dosing, and looks for how the drug is metabolized and excreted by the body in healthy individuals. Drugs that move on to phase two trials continue to look at the safety profile and efficacy in a small group of people with the disease. MDMA formula via Wikimedia. If there are already drugs on the market for the disease—like Zoloft and Paxil for PTSD—new compounds are held to an even higher standard. This is because phase three trials take considerably more time, resources, and money to perform than the previous phases. Phase three trials are much larger, usually take place in several locations, and have more rigorous statistical benchmarks to meet in order to prove efficacy, Kenneth Kaitin, the director of the Tufts Center for the Study of Drug Development told Gizmodo. But is public perception really that bad? Two stories about MDMA—one about its ability to restore lives , and another about its ability to destroy them —hit the mass media within a month of each other. Though some are pushing for the legalization of all drugs, such organizations like Law Enforcement Against Prohibition LEAP remain in the peripheral vision of the public eye. Regardless of public perception, the Food and Drug Administration is remarkably amenable to psychedelic research. He said when he first proposed his research to the FDA in , the agency was quick to approve. It was the Drug Enforcement Agency—which must sign off on the research of any schedule 1 drug—that was slow to approve. However, once Mithoefer cleared that hurdle for the initial study, obtaining approval from both agencies was relatively easy. Mithoefer and his group have now completed the phase two studies of MDMA. As you may have heard , the popular party drug has performed incredibly well. Most of the research and development for new drugs is paid for by big pharmaceutical companies. These companies are notoriously secretive about how much money truly goes into research and development, as well as how that factors into drug pricing. Drug companies often use patents to maintain their proprietary hold on a drug for as long as possible, thus maximizing their profits. So psychedelic research has had to rely mostly on private donations from wealthy individuals and organizations, and some funding from government agencies like the National Science Foundation. But psychedelics have one major leg up on the funding front: previous research. Before the DEA scheduled classic psychedelics in the 70s and MDMA in the 80s, psychiatrists had performed many studies examining safety, mechanism of action, and dosage—laying the groundwork for the clinical trials MAPS is performing today. The phase two trials cost MAPS roughly 5 million. Doblin said he expects phase three trials to be completed by , though pinning an exact date on clinical trial completion is difficult. The FDA reviews the application, decides on how it will be labeled, and inspects the facility where it will be manufactured. This can take anywhere between six months to two years. Because MDMA is at high risk for abuse, MAPS expects it will go through painstaking lengths to prove they have an effective risk management strategy in order for the FDA to give it the green light for commercial use. It will be administered by a team of two therapists in an office where the patient will be monitored overnight. The FDA will suggest a new status for the drug, but ultimately the decision about scheduling lies in the hands of the DEA. According to an agent within the DEA, this process can take up to 12 months. However, its status as a medical drug will not change the criminality of selling and possessing the drug outside of its approved medical uses, Dunagan warned. The MDMA on the street will also still have all the same problems as it does now—with mystery adulterants and dosages. The A. Shop Subscribe. Read on. Subscribe To Our Newsletter. This newsletter comes from the future. Filed to: drugs. Share This Story. Get our newsletter Subscribe.
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Where To Buy MDMA No Prescription
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