12/26/17

Give MDMA a Chance?

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In August of 2017 the FDA designated MDMA-assisted psychotherapy as a breakthrough treatment for PTSD. Bringing MDMA to market as a legal, legitimate therapeutic agent has been the goal of Rick Dobin, the Executive Director of MAPS (Multidisciplinary Association for Psychedelic Studies), since he founded the nonprofit in 1986. That was one year after the DEA classified MDMA, better known as the street drug ecstasy, as a Schedule I controlled substance. Dobin said: “For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way.”

The MAPS press release said the Phase 3 trials will assess the efficacy and safety of MDMA-assisted therapy in 200-300 participants with PTSD in the U.S., Canada and Israel. Two Phase III clinical trial studies will begin enrolling participants in the spring of 2018. Randomized participants will receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period. There will also be 12 associated 90-minute nondrug preparatory and integration sessions. Now that the FDA is onboard, Dobin said MAPS plans to start negotiations with the European Medicines Agency.

Speaking for MAPS, Amy Emerson, said the Phase 2 data was extremely promising. Out of 107 participants, 61% no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months after treatment. Then at the 12-month follow up, 68% no longer had PTSD. “All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.” The Phase 2 trials are being prepared for publication.

The willingness of MAPS to use the existing clinical trial process to scientifically validate the potential therapeutic benefits of MDMA is encouraging. Running the FDA gauntlet for drug approval, for better or worse, is the most effective process we currently have to prevent a return to the days of patent medicines, when anything and everything was promoted as “cures” and “treatments” to an unsuspecting public. Those were the days when cocaine was in tonics (Coca Cola); heroin was in cough suppressants and teething medication; and the typical heroin addict was a middle class woman in her forties.

At least one individual at John Hopkins has referred to the recent interest of MAPS and others into the therapeutic effects of psychedelic substances as a “psychedelic renaissance.”  Writing for Massive, Benjamin Bell said: “Astounding preliminary research suggests psychedelics may yet revolutionize mental health care.” His historical gloss painted the history of the medical use of psychedelics as going from a potential revolution in psychotherapy during the 1950s to drug-addled lunacy by 1968. The culprits responsible for this change, according to Bell, were Timothy Leary and Richard Alport. “Although the pair began as respected researchers at Harvard, their firing coincided with their choice to promote hallucinogens in unique, and distinctly non-academic, ways.”

Unwittingly, when Harvard psychologist Timothy Leary signaled springtime for the “Summer of Love,” promoting LSD as a means to achieve cosmic connection, he also drew closed the curtain on academic research into a class of substances which held massive promise.

Richard Nixon labeled Leary as “The most dangerous man in America.” Alport went to India and a spiritual quest and changed his name to Ram Dass. In 1968, the US government outlawed all hallucinogens, universally restricting research on the substances. In the early 1980s, there was a brief time of psychotherapeutic research with MDMA. “But recreational use quickly captured the spotlight, and MDMA was classified as a Schedule 1 drug” in 1985. This was what motivated Rick Doblin to found MAPS.

According to The Washington Post, Dobin used LSD “as a rebellious, long-haired college freshman in the 1970s.” He believes it helped him see the world and himself in new ways. He wanted to become a therapist and use psychedelics to help others achieve similar insights, but he couldn’t because LSD was banned. When MDMA was criminalized, he realized psychedelics were too much on the fringe of culture to win public support. “The flaw of the early psychedelic movement was that they made it countercultural, a revolution. . . . Culture is dominant. Culture is always going to win.” He decided he had to bring psychedelics as therapeutic agents into the mainstream.

Dobin was admitted to the public policy PhD program at Harvard, shaved off his moustache, cut his hair and “learned to navigate the federal bureaucracy.” He laughed about how simple it was. “You put on a suit, and suddenly everyone thinks you’re fine.” Instead of fighting government officials, he sought to use science to win them over. So MAPS was born. And it was no accident the organization chose PTSD as its initial foray into its quest to end the government ban on psychedelics. Dobin said: “We wanted to help a population that would automatically win public sympathy. . . . No one’s going to argue against the need to help them.”  He added that if you were going to design a drug to be used as an adjunct in psychotherapy to treat PTSD, “MDMA would be it.”

But his dream extends beyond just developing a treatment for PTSD. Rick Dobin dreams of a time when psychedelic treatment centers are in every city. People could go there for enhanced couples therapy, spiritual experiences and personal growth. “These drugs are a tool that can make people more compassionate, tolerant, more connected with other humans and the planet itself.” He thinks they can help address homelessness, war and even global warming. Needless to say, this kind of talk makes others nervous.

Despite its promise, there are risks. What’s sold on the street as “molly” is often not MDMA See “MDMA—Not!” for more on this topic. At high doses, it can cause the body to over heat.  It can cause anxiety and increase stress. Chronic use can cause memory impairment. But there are additional concerns with MDMA not mentioned in The Washington Post.

The National Institute on Drug Abuse (NIDA) related the following in its article on MDMA (Ecstasy) Abuse. MDMA was said to affect the brain by increasing the activity of at least three neurotransmitters: serotonin, dopamine, and norepinephrine. “Like other amphetamines, MDMA enhances release of these neurotransmittersand/or blocks their reuptake,resulting in increased neurotransmitter levels within the synaptic cleft (the space between the neurons at a synapse).” Releasing large amounts of serotonin causes the brain to become depleted of this neurotransmitter, contributing to the negative psychological aftereffects some people experience for several days after taking MDMA.

Low serotonin is associated with poor memory and depressed mood, thus these findings are consistent with studies in humans that have shown that some people who use MDMA regularly experience confusion, depression, anxiety, paranoia, and impairment of memoryand attention processes. In addition, studies have found that the extent of MDMA use in humans correlates with a decrease in serotonin metabolites and other markers of serotonin function and the degree of memory impairment. In addition, MDMA’s effects on norepinephrine contribute to the cognitive impairment, emotional excitation, and euphoria that accompanies MDMA use.

So despite the optimism of individuals like Rick Dobin and Benjamin Bell, there are clear dangers with a renaissance of psychedelic psychotherapeutics. Attributing objections and concerns to over fifty years “of drug prohibition and abstinence-only education,” as well as “a culture that has shaped the negative stigma of all psychedelics,” is disingenuous and dismissive of the legitimate concerns. Should there be further research into the potential for MDMA-assisted psychotherapy as a breakthrough treatment for PTSD? If all they are saying, is give MDA a chance, then absolutely. See the photo in Bell’s article of Timothy Leary singing, “Give Peace a Chance” with John Lennon and Yoko Ono.

But let’s not run ahead of the science to treat other emotional or psychiatric problems; or apply psychedelics to resolve the problems of world peace, homelessness and global warming just yet.

09/1/14

There is Nothing New Under the Sun

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Impression from a Sumerian cylinder seal from 2600 BC. Persons drinking beer are depicted in the upper row.

I have never used any mind altering drug that was not pharmaceutical grade. People who put drugs of unknown composition and purity in their bodies are either ignorant (they don’t know the real risks to the brain and mind), stupid (they know the risk and choose to ignore it), or addicted (they know the risk, want to stop, but find that they can’t). ~ Timothy Leary, in a private conversation with Terence T. Gorski.

Terence Gorski posted this quote at the end of a brief essay, “Poison as a Preferred Pleasure.” He first expressed his amazement with how many people today view alcohol and marijuana as harmless. Even more frightening to him was the willingness of people to experiment with new, largely unknown substances in the pursuit of getting high. See my essay on Playing Chemical Whack-a-Mole.

From the earliest times of culture and civilization, humans have pursued intoxication. According to Ronald Siegal, “Throughout our entire history as a species, intoxication has functioned like the basic drives of hunger, thirst and sex. . . . It is as bold and inescapable as the drug stories that dominate today’s headlines.”

The first mention of drunkenness in the Bible is when Noah became intoxicated after he planted a vineyard and ate some of the grapes. He gets naked, passes out and is seen by one of his sons, Ham. But I’m intrigued by the commentary on this story within a Hebrew midrash, Midrash Tanuma. There, the story is that Noah and Satan entered into a business arrangement to plant a vineyard. It was through this partnership, that Noah learned about the intoxicating qualities of wine. Satan’s contribution was to slaughter a lamb, a lion, a pig and a monkey and fertilize the vineyard’s soil with each in turn. What Noah learned from this was:

If a man drinks one glass, he is as meek as a lamb; if he drinks two glasses, he is boastful and feels as strong as a lion; if he drinks three or four glasses, then behaves like a monkey, he dances around, sings, talks obscenely and does not know what he is doing; and if he becomes intoxicated he resembles the pig.

The process of fermenting beverages like wine and beer runs parallel with the transition of humanity from hunter-gatherers into farmers, and eventually to cities and civilization. Beer was most likely a staple of human diets before wine was. It has even been argued that the discovery of the intoxicating effects of beer was a motivating factor for our hunting-gathering ancestors to settle down and become farmers.

2954474f708cf44b07237af4d40e46e7By the time that writing was invented, beer was no longer just an agricultural product of the rural villages. It was one of the surplus products important to the centralized economy of Sumerian city-states. The discovery of administrative cuneiform documents of the production and consumption of beer illustrates the important economic role beer played in Sumerian culture. The earliest known written documents are Sumerian wage lists and tax receipts which contain the symbol for beer, one of the most common words in the documents.

cuneiform tablet depicting beer allocation, c. 3000 b.c. British Museum Photograph: takomabibelot on Flickr

cuneiform tablet depicting beer allocation, c. 3000 b.c. British Museum Photograph: takomabibelot on Flickr

From the beginning, beer had an important social aspect. Sumerian depictions from the third millennium BCE (like that above) show two people drinking through straws from a shared vessel. The technology to filter out the grain, chaff and debris from beer had been developed, but the continued use of straws suggested this was a ritual that persisted even after straws were no longer needed. Perhaps sharing a drink was a symbol of hospitality and friendship. “It signals that the person offering the drink can be trusted, by demonstrating that it is not poisoned or otherwise unsuitable for consumption.”

Beer had a religious role in Sumerian culture as well. The Hymn to Nakasi was simultaneously a song of worship to the goddess of beer and a recipe for brewing beer! See section 6.1 of the article on Sumerian Beer for the text of the hymn. Nevertheless, Sumerian beer was likely consumed in taverns, similar to medieval times. At the end of the hymn, the goddess Nakasi pours out beer for the drinkers, giving her the role of both brewer and tavern-keeper.  Women were typically the ones who brewed and sold beer in ancient Mesopotamia.

The Egyptians also excelled in the arts of fermenting wine and brewing beer. Not only were such intoxicants for the living, they were said to be used by the dead in the afterlife. Menquet, the Egyptian goddess of beer, was pictured as a woman holding two jars of beer. Hathor, represented as a sacred bull, was the god of wine. He was duly honored on a monthly “Day of Intoxication.”

The Preacher in Ecclesiastes can help put the latest intoxicant fad with synthetic drugs or new psychoactive substances into perspective: There is nothing new under the sun. From the time human beings first settled down into villages, they have looked for new and better ways of getting high.

What has been is what will be, and what has been done is what will be done, and there is nothing new under the sun. Is there a thing of which it is said, “See, this is new”? It has been already in the ages before us. There is no remembrance of former things, nor will there be any remembrance of later things yet to be among those who come after. (Ecclesiastes 1:9-11)

Do you agree with Timothy Leary that people who put drugs of unknown composition and purity in their bodies are either ignorant or stupid?

I have read and used Terence Gorski’s material on relapse and recovery for most of my career as an addictions counselor. I’ve read several of his books and booklets; and I’ve completed many of his online training courses. He has a blog, Terry Gorski’s blog, where he graciously shares much of what he has learned, researched and written over the years. This is one of a series of blog posts based upon the material available on his blog and website.