Psilocybin treatment for PTSD: a Clinical Trial protocol

There have been numerous studies published to date that provide an overwhelming rationale for conducting a Clinical Trial utilizing psilocybin to treat PTSD.  Below is a list of PTSD related issues and the recent research that has provided ample evidence to support such a trial and could function effectively as a key aspect in someone's protocol:

PTSD.  There has been a recent animal model study demonstrating the efficacy of low-dose psilocybin in treating PTSD as well as a 1968 case report on a long-standing chronic pain/depression/PTSD patient treated successfully with psilocybin. The animal model study also demonstrated psilocybin's ability to promote hippocampal neurogenesis.

Depression. A recent Lancet Psychiatry article has shown psilocybin to be highly effective for patients with treatment resistant depression.

No serious or unexpected adverse events occurred during the course of the study and all patients demonstrated a reduction in depression severity at 1 week that was sustained in the majority for 3 months. Eight (67%) of the 12 patients achieved complete remission at 1 week and seven patients (58%) continued to meet criteria for response at 3 months, with five of these (42%) still in complete remission. This is quite remarkable since the equivalent remission rate for SSRIs is around 20%. Unlike current anti-depression medications, psilocybin does not have to be given daily, perhaps only once or twice as in this study.

Social isolation/exclusion. Numerous studies have demonstrated improvement of social cognition deficits in various psychiatric disorders after psilocybin administration compared to placebo. Furthermore, emotional empathy was enhanced after treatment with psilocybin as well as a decrease in social exclusion and social stigmatization.

Addictions. A recent pilot study  involving 15 psychiatrically healthy nicotine-dependent smokers (10 males; mean age of 51 years), with a mean of six previous lifetime quit attempts, and smoking a mean of 19 cigarettes per day for a mean of 31 years at intake demonstrated an 80% abstinence at 6-month follow-up. The observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and/or pharmacological therapies (typically < 35%).

There are currently three Clinical Trials examining psilocybin's ability to help individuals with addiction related disorders.

Existential distress.  To me, this is key.  Existential distress is, in my opinion, what gives rise to PTSD in the first place. When a Warfighter heads out on patrol day after day not knowing if he will return, this creates a definite existential distress.  Why some develop PTSD as a result of this experience and others do not is not known but I suspect levels of pre-existing systemic inflammation may play a key role. A future study will examine psilocybin's ability to decrease inflammation in the brain.

Two recent studies. one performed at NYU, the other at Johns Hopkins that provided psilocybin to cancer patients with life-threatening in an attempt to mitigate their existential distress will soon be published. Preliminary results have been provided by NYU and by Johns Hopkins.  It is reasonable to infer that what is effective for these patients will be effective for those with PTSD as well.

Anger/violence. A recent study from the Journal of Psychopharmacology looked at 302 men ages 17-40 in the criminal justice system. Of the 56 percent of participants who reported using hallucinogens, only 27 percent were arrested for later IPV as opposed to 42 percent of the group who reported no hallucinogen use being arrested for IPV within seven years.

Dr. Peter Hendricks, one of the study authors, commented that "A body of evidence suggests that substances such as psilocybin may have a range of clinical indications," he said. "Although we're attempting to better understand how or why these substances may be beneficial, one explanation is that they can transform people's lives by providing profoundly meaningful spiritual experiences that highlight what matters most. Often, people are struck by the realization that behaving with compassion and kindness toward others is high on the list of what matters."

Suicidal ideations. Two previous studies have demonstrated psilocybin's potential effectiveness in preventing suicides.  A 2013 article in PLoS One used data from over 130,000 individuals drawn from years 2001 to 2004 of the National Survey on Drug Use and Health and demonstrated no significant associations between lifetime use of any psychedelics, lifetime use of specific psychedelics (LSD, psilocybin, mescaline, peyote), or past year use of LSD and increased rate of any of the mental health outcomes. Rather, in several cases psychedelic use was associated with lower rate of mental health problems to include suicide.

A 2015 article from the Journal of Psychopharmacology by researchers from the University of Alabama and Johns Hopkins demonstrated lifetime classic psychedelic use was associated with a significantly reduced odds of past month psychological distress (weighted odds ratio (OR)=0.81 (0.72-0.91)), past year suicidal thinking (weighted OR=0.86 (0.78-0.94)), past year suicidal planning (weighted OR=0.71 (0.54-0.94)), and past year suicide attempt (weighted OR=0.64 (0.46-0.89)), whereas lifetime illicit use of other drugs was largely associated with an increased likelihood of these outcomes.

Anxiety. Numerous studies have demonstrated a decrease in anxiety in those who have taken psilocybin with the proper Set and Setting. One specific 2011 study from UCLA titled Pilot study of psilocybin treatment for anxiety in patients with advanced-stage cancer demonstrated a significant reduction in anxiety at 1 and 3 months after treatment as measured by the State-Trait Anxiety Inventory and the Beck Depression Inventory revealed an improvement of mood that reached significance at 6 months in 12 adults with advanced-stage cancer and anxiety.

In conclusion, with the possible exception of Ayahuasca, there exists no other known compound that has shown effectiveness with all the various issues manifested in those afflicted by PTSD.  It is less toxic than caffeine, not addicting and has to be given only once or twice. This is an excellent opportunity for the DoD and/or VA to conduct a Clinical Trial utilizing psilocybin to treat PTSD in an attempt to decrease suicides in active duty military and veterans, to take whatever steps necessary to find the best treatment for this debilitating condition.