- Steve Duncan / Horizons Media, Inc.
Psychedelic drugs are often associated with images of the 60s, Burning Man, or your average rave.
But in the next decade, all that could change, according to Rick Doblin, who has a plan to make it happen.
Doblin, the founder and executive director of the nonprofit Multidisciplinary Association for Psychedelic Studies, outlined his next steps toward getting MDMA approval at the Horizons Conference, an annual forum to discuss psychedelic drugs, in New York in October.
His goal: Get MDMA approved for use in psychotherapy for people with post-traumatic stress disorder (PTSD) by 2021. In order to do that, Doblin needs the FDA to sign off on the design of his Phase 3 trial, which is the late-stage human trial that will determine whether the FDA approves the drug.
MDMA, otherwise known as Ecstasy or Molly, was invented by the pharmaceutical company Merck in 1912. Today, the drug is considered an illegal substance with no medical benefit and a high potential for abuse. It’s both a stimulant and a psychedelic, meaning it has both energy-raising and hallucinogenic properties. Once it reaches the brain, MDMA amps up the activity of certain neurotransmitters, or chemical messengers, including serotonin, dopamine, and nor epinephrine, which are involved in mood regulation. The drug also can also have some well-documented side effects, including anxiety, irritability, and a rise in body temperature and blood pressure.
Doblin thinks it could also be a viable treatment for use in psychotherapy to treat PTSD. And he’s not alone.
Psychotherapy is a popular form of treatment for various forms of mental illness that involves a licensed therapist or psychiatrist talking with a patient at a regularly appointed time each day, week, or month about what he or she is experiencing.
Typically, psychotherapy is paired with medication, and Doblin and others think psychedelic drugs could be just one more of these available medications.
Although unlikely to happen within this time frame, here’s how it would work if MDMA were approved: A person who’d been diagnosed with PTSD would go into a special mental health clinic (Doblin dreams these facilities would one day be labeled “psychedelic clinics”). Once there, he or she would be given 125 milligrams of MDMA in the form of a pill, which is considered a normal dose. Then, the patient would talk through his or her experience with a trained therapist.
Ideally, Doblin said at the conference, the therapist would also have used MDMA at some point in the past. Doblin estimates this process would be repeated in two or three sessions until the patient no longer has severe PTSD symptoms.
The path to approval
- Reuters/ DEA
Right now, Doblin’s organization is getting geared up to test MDMA in Phase 3 trials, the late-stage tests of the drug that the FDA will consider to help them decide whether the treatment is worth approving or not. The FDA will be looking to make sure the drug is safe and effective, with little chance of being abused.
For the study, in which Doblin hopes to enroll 400 people, half of the participants will receive a placebo and the other half will receive a 125 milligram MDMA pill. It’ll be a double-blind trial, meaning that both the physician administering the drugs and the patient receiving them won’t know whether the patient is taking the MDMA or a placebo. The trial participants will then undergo 15 “sessions,” in which the participant talks with a therapist about their trauma: Three of them will include the drug or placebo; the other 12 will not.
Unlike other phase 3 pharmaceutical trials of its kind, which often have thousands of participants, Doblin only aims to enroll 400 people in this trial. He says that’s because the magnitude of the results of this study would be strong enough to be statistically significant without increasing the number of participants in the trial. Studies on the brain tend to be smaller than other studies for this reason.
Plus, unlike new drugs, the effects of MDMA – at least as a recreational drug – have been heavily documented.
“The FDA knows more about MDMA than it will know about any other drug that it has ever approved or will ever approve,” Doblin told Business Insider.
What other scientists think of Doblin’s plan
Some researchers who study antidepressants are interested to see MDMA-assisted psychotherapy for PTSD succeed one day.
For one thing, most of today’s medications treat PTSD only by relieving some of its symptoms, they say. For another, FDA approval for MDMA doesn’t seem as far-fetched as it sounds, so long as the people seeking approval are being pragmatic about it.
“Right now, psychological interventions are purely palliative [for PTSD],” Vanderbilt University psychiatry and psychology professor Steve Hollon, who’s studied antidepressants and other treatments for PTSD, told Business Insider. “If there’s something that can do better than what we do now … we might as well try it out.”
And when it comes to getting approval, the process could be more challenging for a nonprofit that’s not as accustomed to FDA regulations as a big pharmaceutical company. Richard Shelton, a psychiatry and behavioral neurobiology professor at the University of Alabama at Birmingham told Business Insider that the biggest stumbling block to getting approval will be dealing with all these regulatory logistics.
“My biggest worry is that it’s folks that don’t have experience and just don’t understand the complexity of getting through the FDA and DEA hurdles,” he said.
The drug will also be very tightly controlled, if approved medically, by the DEA. Shelton said he guesses the drug will move from a schedule 1 (no accepted medical use, highly likely to be abused) drug to a schedule 2 (still high potential for abuse, but in the same category as painkillers like Vicodin and Oxycontin). This means the highly regulated drug will be a logistical challenge to keep it in stock.
“I’m interested to see if the average psychiatrist is going to be willing to do this,” he said.
A different kind of drug company
Because MDMA was originally created in the early 1900s, it’s no longer protected by a patent. A drug that’s off patent can essentially be marketed by any company that wants to take the steps to make it. That means it’s not as profitable as a new drug, which has patent protection for 20 years after being filed, meaning only the company with the patent can make the drug and set its own prices.
With all the controversy surrounding price hikes on drugs that have gone off patent, Doblin’s organization has a different plan for its off-patent MDMA research.
If the drug gets approval by the FDA, Doblin’s organization, MAPS, will have about 6.5 years, he estimates, of data exclusivity before other companies could start making competing MDMA pills for MDMA-assisted psychotherapy for patients with PTSD.
And unlike a big pharmaceutical company that can afford to pay for expensive phase 3 trial, MAPS will have to do its best on a limited budget. But, if a bigger pharmaceutical company wants to step in and start running experiments of their own, Doblin said his organization is completely open to it. MDMA isn’t much of a draw to pharmaceutical companies that rarely delve into psychotherapy, off-patent drug development, or currently illegal drugs.
“If the big pharma companies want to do this, we’ll help them,” he said.