And Now for Something Completely Different….

While most people associate “magic mushrooms” and “X” with illicit drug use some recent research indicates these substances may have a role with some of the most difficult-to-treat psychiatric patients.

Two studies published in the December edition of the Journal of Psychopharmacology used psilocybin and similar study designs to treat cancer patient’s depression and anxiety. Previous studies have (unsurprisingly) shown high rates of both conditions in cancer patients with life-threatening diagnoses along with difficulty in adequately treating these same conditions leading to a variety of poor outcomes. (e.g. decreased survival rates, increase in suicides, decreased function, among others)

Utilizing a crossover study and high or moderate dose of psilocybin versus placebo or very low dose psilocybin both studies found not only a marked improvement in both depression and anxiety scores but also improving measureable factors such as spiritual wellbeing, general life satisfaction, and quality of life, life meaning, and optimism, while decreasing cancer-related demoralization and hopelessness, and death anxiety. Even more remarkable the effect on depression and anxiety (with reduction rates as high as 80%) persisted for 6-8 months with only a single dose of psilocybin!!  Both studies even used a Mystical Experience Questionnaire (MEQ30) which “is a self-report questionnaire that evaluates discrete mystical experiences induced by serotoninergic psychedelics and is sensitive to detecting psilocybin-induced mystical experiences.” As an additional benefit, no subjects in either study suffered from any serious side effects.

 

Along this same vein the FDA announced this week that based on the success of small drug trials it is allowing large-scale Phase 3 clinical trials to study the use of MDMA, or Ecstasy, for patients with severe PTSD. The Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit group that advocates for the medical use of banned drugs, sponsored six Phase 2 studies that led to the FDA’s decision.

In 2 of the trials they studied combat veterans, sexual assault victims, firefighters and police officers that suffered from PTSD and had not responded to previous treatments. The average duration of symptoms was 17 years! Subjects were given 3 doses of MDMA a few weeks apart under supervision of a psychiatrist along with psychotherapy. This was also a crossover study.

One study showed a 56% decline in severity and by the study conclusion 2/3 no longer met the criteria for PTSD. In addition improvements persisted for over a year. The researchers have applied for “breakthrough therapy status” with the FDA which could allow approval by 2021. Other researchers urge caution, using the opioid crisis as an example of how the drug could be abused.

As a historical aside, MDMA was first patented in 1914 but in 1978 it was resynthesized by chemist Dr. Alexander Shulgin. (Dr. Shulgin was my toxicology professor during my MPH studies at UC Berkeley – an interesting man to say the least!) He gave it to friends in the psychiatric field to use for augmenting psychotherapy but when it spread to more general recreational use the FDA classified it a Schedule 1 drug and initial research was halted.

The results so far are promising but likely a long way off for routine clinical use.

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