3,4-Methylenedioxymethamphetamine, commonly known as ecstasy, is a psychoactive drug primarily used as a recreational drug. The desired effects include altered sensations and increased energy, empathy, and pleasure. When taken by mouth, effects begin after 30–45 minutes and last 3–6 hours.
That’s because the application requires researchers to reference a drug master file: a comprehensive dossier of everything ever published about that drug, from its chemical breakdown to its known risk factors. If this is the first time anyone has studied the drug, it’s a massive undertaking: drug master files are easily hundreds of pages. Luckily for MAPS, the FDA already has a drug master file on hand, submitted by MAPS back in 1986 and updated annually.
The application also needs to include an investigator’s brochure, which outlines the details of how the study will operate: not just how much of the drug will be used, but why and with what other methods. In MAPS’s trials, researchers dose PTSD patients with MDMA before guiding them through a psychotherapy session—they’ve found evidence the drug helps patients tap into the trauma at the core of their disorder without having to relive it in the same visceral, terrifying way they would if they were sober. MAPS would need to include the details of this therapy in its investigator’s brochure. After sending in the application, the FDA decides whether or not the study would be in the public interest. If it deems the study worthy, you get your IND number.
These steps are necessary for any drug trials on humans, but research involving Schedule I drugs have additional requirements through the Drug Enforcement Administration. Medical doctors are licensed to administer Schedule II, III, IV, and V drugs, but not Schedule I, so they have to apply to the DEA for special permission to administer a Schedule I drug specifically in the context of the study, Halpern said.
PURE MDMA CRSTAL
In MAPS’s case, the doctor involved is Dr. Michael Mithoefer, a psychiatrist based out of Charleston, North Carolina who has been researching MDMA-assisted therapy for more than a decade. Mithoefer already has a Schedule I license granted back when the trials began. That license means only Mithoefer is able to actually handle and distribute the MDMA. The DEA has specific requirements for Schedule I registration, including a criminal background check, and a site inspection of the clinic where the drugs will be kept and administered. These requirements transformed Mithoefer’s office from a typical therapist’s office into a veritable bank vault.
“We have to have a 2,000 pound safe, and it has to be alarmed, and the doors of the room where the safe is have to be alarmed, and then the building has to be alarmed,” said Amy Emerson, the executive director and director of clinical research at MAPS Public Benefit Corporation, a wholly owned subsidiary of MAPS. “So that’s the security part of it.” molly powder
With the paperwork squared away and the therapist office cum Mission: ImpossibleCIA vault ready for its first deposit, all that’s left is to get the goods. But MAPS obviously can’t just call up the Walter White of Molly and ask for a particularly large order. The government has its own library of drugs available for researchers, but limits access to scientists investigating the harmful effects of drugs and addiction, not the possible benefits.(molly powder) Luckily there is at least one pharmaceutical company willing, and legally able, to cook up a batch.
A Recipe for Molly
Somewhere in the English countryside, off the coast of the North Sea, there’s a pharmaceutical company contracted to make MAPS’s MDMA. An expert at the company was more than happy to talk to me, but we had to keep some details secret, including the company’s name and location, and name of the person I interviewed. When you’re about to make 1,000 grams of an exceptionally high quality, 99 percent pure version of a popular party drug, you want to take some precautions.
“It might attract some unwanted attention,” my source told me.
The pharmaceutical manufacturer—let’s call them Company X, for the hell of it—won’t be producing MDMA tablets. This isn’t like a hit of Molly you buy off a girl wearing white fuzzy boots at an outdoor concert in the middle of summer. Company X will be making the active pharmaceutical ingredient, or API: the 99 percent pure, powdered form of the drug. Just like a Tylenol pill isn’t pure acetaminophen, a Molly tablet isn’t pure MDMA. There are fillers and binders (and in the case of street Molly, a whole host of other possible ingredients) to turn the pure API powder into something that’s easy to pop.
The basic “recipe” for making MDMA is available in chemistry literature: reaction schemes that let the company’s chemists know which ingredients to combine in which way to create the target molecule. In fact, the basics of this information can be found through a simple Google search. But to make MDMA that meets GMP standards, the company needs more detail than just the basics.molly powder