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Post-Traumatic Stress Disorder and Experimental Mind-Altering Drugs

2016-06-29

From an article in the New York Times (NYT):

“It’s a critical time for two important but still controversial areas of psychiatry: the search for a blood test or other biological sign of post-traumatic stress disorder [PTSD], which has so far come up empty, and the use of recreational drugs like ecstasy and marijuana to treat it.”

A study supported by Pfizer had one of its centers at New York University (NYU), where 14 of the 50 subjects were recruited.  The study’s lead investigator was Dr. Alexander Neumeister, who has resigned from his post following the confirmation of allegations that claimed irregularities in the study.  The university insisted that no patients were harmed in the study, but Dr. Neumeister had clearly violated study protocols and some patients felt whipsawed.  One complained that he had been forced to discontinue his regular medications several times in the course of repeated false starts of his study participation.

The basic facts of the case:

“Dr. Charles Marmar, the chairman of the psychiatry department at N.Y.U., said that people working with Dr. Neumeister had reported concerns about the lab’s compliance with research standards. Once some of those issues were confirmed, Dr. Marmar said, the university placed Dr. Neumeister on leave, “and suspended all activity, suspended access to all accounts. I took control of those studies.” Dr. Neumeister later submitted his resignation.”

The drugs used in these studies had similarities to marijuana; others resembled “ecstasy”, a synthetic recreational drug (“drug of abuse”).  Some drugs are “fatty acid amine hydroxylase” (FAAH) inhibitors which are compounds that prevent the body from breaking down anandamide, the body’s internal version of the active ingredient in marijuana.  Anandamide has effects in the body similar to those of marijuana, that is, delta-9 tetrahydrocannabinol (THC) and related compounds.  It is believed that the body’s internal self-regulation is mediated by compounds like anandamide; THC mimics the effects of anandamide.  The body responds to anandamide through the cannabinoid receptors.

Numerous experimental compounds have been developed that are inhibitors of FAAH, and some of these have gone through clinical trials.  One of these trials in Europe was stopped after six patients developed severe side effects and one died.  Other trials were suspended as a precautionary measure after this disastrous trial.  Other compounds are still being actively investigated, but none has reached clinical use.

Ecstasy, on the other hand, is 3,4-methylenedioxymethamphetamine (MDMA), a member of the substituted amphetamine class of drugs.  Its only use is “recreational”, and it is said to have empathic and euphorogenic properties as well as heightening sensations.  It also increases body temperature, blood pressure, and heart rate, and may cause dehydration as a result.  Levels of serotonin, dopamine, and norephinephrine in the brain are increased.

Studies have been and are being done with low doses of MDMA to treat post-traumatic stress disorder.  After its first discovery in the 1970’s, a number of psychotherapists used it “off-label” for various disorders, particularly PTSD.  MDMA rapidly became a popular “recreational” drug among young people at dance parties.  MDMA was first placed on Schedule I (“no accepted medical use and…”) in 1984 and has been actively attacked by the FDA since then.  A number of adverse reactions and a few deaths were reported from “raves” (spontaneous dance parties.)

The controversial nature of the drugs (cannabis-like or cocaine-like in effect) makes research on human subjects difficult and dangerous.  The case of the NYU study is an object lesson in the dangers of protocol violations.  Dr. Neumeister was reported to have conducted “lax oversight”, falsified records (including forging signatures of researchers), and kept inaccurate case histories.  One patient that NYT interviewed complained that there was no followup after the study was completed and he was “on my own” afterwards.  NYU was said to have shut down eight clinical studies at its psychiatric research center and accepted Dr. Neumeister’s resignation.

There is a confused area between “recreational” drug use and therapeutic use to alleviate symptoms of anxiety, depression, and anomie in patients with known psychiatric disorders.  In many cases, psychiatric patients will self-medicate with drugs, both prescribed and illegally obtained, for distressing symptoms.  Drug use may relieve symptoms temporarily yet cause exacerbation due to withdrawal or overuse.  Use of psychoactive drugs without close professional supervision can be dangerous; few clinicians and psychiatrists have the training to effectively supervise this type of treatment.

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