From Proscribed to Prescribed: Party Drug Is One Step Closer to Medical Use
MDMA (3,4-methylenedioxy-methamphetamine), popularly known as Ecstasy, X, E, and Molly, is a synthetic, psychoactive drug that has similarities to both the stimulant amphetamine and the hallucinogen mescaline.
It produces feelings of increased energy, euphoria, compassion, trust, and empathy toward others, and distortions in sensory and time perception.
The substance has long suffered a bad reputation as a dangerous party drug – one with no positive therapeutic benefits.
That’s far from the truth, as researchers and therapists back in the 1970s knew.
The late biochemist and pharmacologist Dr. Alexander Shulgin studied MDMA extensively, and believed it would be useful in therapy due to its disinhibiting effects. Because of its ability to help users to strip away habits and perceive the world clearly, Shulgin called the drug “window.”
Shulgin gave his friend, psychotherapist Leo Zeff, a sample of MDMA to try. Zeff was so impressed with the drug that he canceled his plans to retire so he could promote its use. He traveled around the U.S. and occasionally to Europe, eventually training an estimated 4,000 psychotherapists in the therapeutic use of MDMA. Zeff called the drug “Adam,” believing it put users in “a state of primordial innocence.”
By the late 1970s, many psychotherapists were using MDMA in therapy sessions with great success.
But by the early 1980s, a recreational market had developed. This led the Drug Enforcement Administration (DEA) to schedule an emergency hearing to classify the drug as a Schedule I substance – the most restricted class of drugs – in 1985.
Expert witnesses testified that the drug had valid medical uses, and a presiding judge recommended that MDMA be classified as Schedule III, which would have allowed doctors to continue using it in therapy.
DEA administrator John C. Lawn overruled, and classified the drug as Schedule I.
The federal government considers Schedule I drugs to be among the “most dangerous,” with no known medical benefits and the potential for “severe psychological or physical dependence.”
Possession of a ”trace” of a Schedule 1 drug by a first-time offender can result in 15 years in prison and a $125,000 fine.
In 1986, Dr. Rick Doblin, one of Dr. Zeff’s students, founded the non-profit research organization Multidisciplinary Association for Psychedelic Studies (MAPS), with the goal of funding clinical trials on MDMA and making it an FDA-approved prescription medication by the year 2021.
In early 2015, both the FDA and the DEA approved studies of MDMA, which appear to be signs of positive changes to come.
Research into MDMA-assisted psychotherapy is showing promising results. Most of the research MAPS does is on MDMA use for post-traumatic stress disorder (PTSD), but studies on the drug’s use in treating social anxiety in autistic adults and anxiety associated with life-threatening illness are being conducted as well.
Depression, substance abuse, relationship problems, premenstrual syndrome, and autism are among other psychiatric disorders MDMA-assisted therapy has been reported to treat with great success.
MDMA eliminates the typical fear response and increases communication, and is often referred to as an “empathogen or an “entactogen,” or “penicillin for the soul” for these reasons.
In the following video, four women who received MDMA-assisted therapy for PTSD talk about their experience and success with the treatment.
Now, it looks like MAPS may reach their goal of making MDMA an approved prescription drug in five years.
The organization is wrapping up their Phase 2 clinical trials. These trials consisted of at least eight studies that Brad Burge, the director of communications for MAPS, recently told Inverse treated 136 people using MDMA-assisted psychotherapy for PTSD.
One of the early studies conducted by MAPS showed that 83 percent of the study participants no longer showed signs of PTSD two months after treatment, and long-term follow-ups conducted an average of four years later showed that most of those benefits lasted. That was a proof-of-concept study, with just 20 participants, all of whom had psychotherapy as well. (Twelve were given MDMA, and eight were given a placebo; 25 percent of those on the placebo improved, too.)
Though small and preliminary, the results were encouraging enough to help lead to Phase 2 clinical trials, the second in the three sets of human trials the FDA requires before considering a new drug for approval.
The researchers are still collecting data and have not yet published Phase 2’s complete results, but the final experimental treatment in all of these studies has already been given. Until the studies are published and analysed, however, we won’t know how effective MDMA-assisted psychotherapy was compared to current treatments or a placebo.
Now that Phase 2 is almost complete, MAPS is meeting with the FDA to plan Phase 3, which will involve 200-400 subjects with PTSD from all sorts of causes across the U.S., Canada, and many other countries. Phase 3 will start in 2017, and it will take four to five years to finish – right on schedule for FDA approval of MDMA in early 2021, if all goes as planned.
In an interview with Inverse, Brad Burge explained why MDMA is so useful in treating PTSD:
With MDMA, people tend to stay more grounded. They become more aware of the feelings that they’re having inside their body, which is very useful for psychotherapy and dealing with psychological trauma.
Also, MDMA has a direct effect on the amygdala that other psychedelics don’t seem to have. MDMA affects the part of the brain that’s mostly responsible for fear, the flight or fight response. With people who have PTSD, their amygdala is hyperactive. MDMA directly reduces that; we see it in MRI brain imaging. So when people are recalling their trauma in the context of a therapy session, they don’t freak out at that same level of chemical activation. I like to call it a “chemical security blanket,” because people remain self-aware even while they’re talking about their difficult state.
…with MDMA-assisted psychotherapy, the model is that people are getting to the root of their trauma. And that’s what we’ve seen going on in the studies. It really only takes 2 to 3 sessions to achieve a significant reduction in their PTSD symptoms to the point where, even years later, people still aren’t exhibiting symptoms.
Burge also went on to explain that Big Pharma isn’t really interested in developing MDMA into a prescription drug because the patent for it has expired. MAPS is currently the only organization in the world that is funding clinical trials of MDMA-based psychotherapy. MAPS is a non-profit that relies entirely on donations. So far, all of their funding has come from private donors and foundations.
While the possibility of legalization of MDMA and other psychedelic drugs (including psilocybin, the major hallucinogenic component in “magic mushrooms,” which has shown long-lasting decreases in anxiety and depression in studies), is a positive action because it will lead to more widespread availability of these treatments, one has to wonder: does limiting access to these substances – and enacting laws to restrict or prohibit their use -violate human rights?
Drug-policy lawyer Charlotte Walsh thinks so.
Walsh told Roc Morin of The Atlantic that alcohol and tobacco cause more harm to humans than psychedelic drugs do, and that governments in both the UK and the US ignore that information.
In essence, the current argument against psychedelic drugs tends to be circular: illegal drugs are bad because they are illegal.
Walsh says that blanket drug prohibition is a violation of international human-rights law:
The tradition in English law was always to intervene as little as possible. That concept has been dying in more recent years. This reverses that presumption, replacing it with an assumption that you can’t do something unless the government explicitly says you can. This violates classic liberalism, where you have the concept of limitations of power, as most famously espoused by legal theorist John Stuart Mill. How much power can the state legitimately hold over the individual? Mill laid down the principle as prevention of harm to others.
She goes on to explain that paternalism (when people in positions of authority restrict the freedom and responsibilities of those “subordinate” to them in the subordinates’ supposed best interest) is illegitimate and infantilizing:
Even if you could make a case for that kind of paternalism, how can imprisonment possibly be for our own good? In the majority of cases, the primary and often only harm being suffered by the individual is due to the punishment imposed rather than from the substance use itself.
Burge is optimistic about the use of psychedelic drugs as medicine becoming more widely accepted:
We’re also seeing a declining faith in the War on Drugs, and people are increasingly willing to put science before stigma when it comes to evaluating the safety and effectiveness of these powerful compounds.
Current treatments for PTSD include psychotherapy (“talk” therapy) and medication. Sometimes, a combination of both is used.
Psychotherapy is the primary treatment for PTSD because while medications may treat some of the symptoms commonly associated with the disorder, they will not relieve a person of the flashbacks or feelings associated with the original trauma.
Many people spend years – even decades – in therapy and do not see much improvement.
MDMA offers a possible long-term solution for those people.
Andrew Feldmár, a psychologist who is working on a Vancouver study into MDMA-assisted psychotherapy, said, “I have worked with people who have been for years on major tranquilizers or major antipsychotics who after one or two MDMA sessions never had to take the ordinary standard pharmaceutical drugs again.”
Conventional treatment for PTSD, depression, and anxiety usually consists of the use of medications, therapy, or a combination of both.
Despite their widespread use, those medications are not without risk or controversy. One only has to look at recent headlines to see the possible serious risks linked to the drugs:
Antidepressant Studies Corrupted by Pharmaceutical Company Influence, Analysis Shows
Antidepressant Use During Pregnancy Linked to Increased Autism Risk
Disturbing Truth About Paxil Revealed: Drug Is NOT Safe for Teens
Antidepressants Linked to Violent Behavior in Young People, Study Shows
Antidepressant Drug Research Has a Problem, Study Says
Antidepressant Trials Exclude Most “Real World” Patients With Depression
In addition, antidepressants and other prescription drugs aren’t always helpful: the medications usually take at least two weeks to show any effect, and for some people, they don’t work at all.
Treatment with psychedelics and compounds like MDMA represent “a total paradigm shift in the way that mental illness is treated,” Dr. Evan Wood, a psychiatric researcher at the University of British Columbia, said:
The re-emerging paradigm of psychedelic medicine may open clinical doors and therapeutic doors long closed. This is an area that could potentially bring about major changes in people, without a sort of chronic-disease model where people would be forever on an expensive [pharmaceutical] medication. It’s a totally different model: it’s not one pill every day, it’s one experience and we’re going to try to heal you.
Substances commonly known as “party drugs” like MDMA, magic mushrooms, and ketamine could offer true long-term relief from debilitating conditions like PTSD, depression, and anxiety.