Tag: post traumatic stress disorder

01/29/19

Turn On, Tune In, Drop Out

Credit: YouTube

At the end of the Second World War in 1946 the Army wanted to show how new “experimental” treatments at the time, hypnosis and injections of sodium pentothal, were helping psychiatric casualties of war. These cases of “battle neurosis,” what we now call PTSD, were highlighted in a documentary called “Let There Be Light.” John Houston spent two months filming the documentary at Mason General Hospital. We see a paralyzed man (with no physical injury to explain it) walk; a soldier with amnesia regained his memories; and a man with a severe stutter cured. Then the Army prohibited Houston from releasing the film; it wasn’t until 1980 that it was released to the public.

Houston thought the reason it was sidelined was the film contradicted how the government portrayed the returning soldier. The film opened with this quote: “About 20% of all battle casualties in the American Army during World War II were of a neuropsychiatric nature.” In his autobiography he said: “I think it boils down to the fact that they wanted to maintain the ‘warrior’ myth, which said that our Americans went to war and came back all the stronger for the experience, standing tall and proud for having served their country well.” The official, flimsy, reason given was it was a violation of the soldiers’ privacy. Yet “the soldiers themselves were knowingly and consensually filmed.” It seems that Houston was too realistic.

None of the scenes were staged. “The cameras merely recorded what took place in an Army Hospital.” Writing for ZeroHedge, Tyler Durden said although the film intended to optimistically show the new treatments unavailable to soldiers of previous wars, but the audience takeaways were not positive. Instead of showing the potential for healing, audiences remembered “the psychosomatically paralyzed soldier being carried into a room, the trembling amnesiac, and the incommunicable stuttering of a psychologically damaged man.”

The soldier’s joy at the successful treatment did not explain, for audiences unfamiliar with such psychological phenomena, how such a problem could manifest. In all three cases of treatment, Huston believed he was showing the world the tremendous breakthroughs of psychiatric medicine, but instead, he showcased the horrors of war, without even having to visit a battlefield.

“Battle neurosis” was known as “shell shock” in World War I. Within the first edition of the Diagnostic and Statistical Manual (DSM) it was “gross stress reaction,” which would become posttraumatic stress disorder in the third edition. By then we had the Korean War, the Vietnam War and their portrayals on television and in the movies with the Deer Hunter, Apocalypse Now, MASH and others.

I wonder if another reason the Army decided to suppress Let There Be Light was a 1946 movie with Dana Andrews, Myrna Loy and Fredric March called “The Best Years of Our Lives.” It told of the difficult and traumatic adjustments of three servicemen returning home after WWII. We see problems with alcoholism, unemployment and adultery. Samuel Goldwyn was inspired to make the movie after reading an article in Time about the problems experienced by men returning to civilian life. It won seven Academy Awards, including Best Picture. And it was the highest grossing and most attended film in the US and UK since Gone with the Wind.

These days ecstasy or MDMA is seen as a promising treatment for PTSD. The British medical journal The Lancet published a study of 26 individuals with chronic PTSD who were not helped by traditional methods. The New York Times reported “The improvements were so dramatic that 68 percent of the patients no longer met the clinical criteria for PTSD.” There were also improvements with sleep and becoming more conscientious.

The results, which mirror those of similar, small-scale studies of the illegal drug in recent years, come as MDMA is about to enter larger, Phase 3 trials this summer. Based on previous results, the Food and Drug Administration has given MDMA breakthrough therapy status, which could speed approval. If large-scale trials can replicate safety and efficacy results, the drug could be approved for legal use by 2021.

If approved by the FDA, MDMA would only be administered after three sessions of therapy by a licensed psychotherapist. During the fourth session, the patient takes the MDMA, and two therapists—one male and one female—are at the patient’s side as guides. Dr. Michael Mithoefer, lead author of The Lancet study said: “We encourage them to set aside all expectation and agenda and be open. Experiences tend to be very individual.” The drug releases hormones and neurotransmitters facilitating feelings of trust and wellbeing, allegedly allowing patients to re-examine traumatic memories.

The large-scale trials, which began in the summer of 2018, included up to 300 participants at 14 sites. Phase 3 trials are expected to cost $27 million. The funding comes from donations, not Pharma. David Bonner, of Dr. Bonner’s Magic Soaps, gave $5 million, as did an anonymous donor only known as Pine.

There is a possibility they will not be able to replicate the success of the previous trials. Yet there is a current lack of effective therapy for PTSD. “Only about one in three combat veterans with PTSD are effectively treated.”

The study was sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS). According to a MAPS press release, the study replicated previous research with an acceptable risk profile for MDMA. The most frequently reported adverse reactions were anxiety, headache, fatigue, and muscle tension.

MDMA was originally patented by Merck in 1912, but never marketed and the patent lapsed. The FDA would grant temporary data exclusivity to MAPS, giving it a five-year monopoly in the U.S. MAPS plans to funnel sales to a for-profit corporation, which would then return the money for more clinical research into the use of MDMA with other disorders. Rick Doblin, the founder of MAPS, has a vision for legalizing MDMA. See “Give MDMA a Chance?” for more on MAPS and Doblin.

But there are risks, despite the potential of MDMA. It can cause anxiety and increase stress. Chronic use may cause memory impairment. At high doses, it can cause your body to overheat. Chronic use may cause memory impairment. The National Institute on Drug Abuse (NIDA) said MDMA affects 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 memory and 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.

Rick Doblin has been trying to achieve a legal justification for MDMA use for decades. Unlike Timothy Leary, he sought to embrace the dominant culture instead of turning on, tuning in, and dropping out. And he just may achieve his goal, with MDMA therapy for PTSD now in Phase 3 clinical trials. I suspect Doblin is not just trying to help facilitate more effective treatment for PTSD. Rather, it is a means to an end—an end parallel to that of Timothy Leary.

Leary first used the phrase “turn on, tune in, drop out” in a speech he gave on September 19,1966. His purpose was to encourage people to detach themselves from existing conventions in society by embracing the use of psychedelics. “Like every great religion of the past we seek to find the divinity within and to express this revelation in a life of glorification and the worship of God. These ancient goals we define in the metaphor of the present—turn on, tune in, drop out.” In his 1983 autobiography he explained what he had meant by the use of this metaphor:

“Turn on,” meant go within to activate your neural and genetic equipment. Become sensitive to the many and various levels of consciousness and the specific triggers that engage them. Drugs were one way to accomplish this end. “Tune in,” meant interact harmoniously with the world around you—externalize, materialize, express your new internal perspectives. “Drop out,” suggested an active, selective, graceful process of detachment from involuntary or unconscious commitments. “Drop Out” meant self-reliance, a discovery of one’s singularity, a commitment to mobility, choice, and change. Unhappily my explanations of this sequence of personal development were often misinterpreted to mean: “Get stoned and abandon all constructive activity.”

I suspect we will see more of the same if MDMA is approved for the treatment of PTSD.

12/26/17

Give MDMA a Chance?

© lightwise | 123rf.com

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 Doblin, 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. Doblin 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, Doblin 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, Doblin 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.

Doblin 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 Doblin 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 neurotransmitters and/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 memory and 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 Doblin 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.