One step away

A recent article in the Guardian announced the Imperial College London has plans to commence a study that will utilized psilocybin to treat individuals with clinical depression.  The pilot study will be conducted by Professor David Nutt and Dr Robin Carhart-Harris at Imperial College's Neuropsychopharmacology Centre in London on 12 patients who have failed to respond to conventional treatment.  Positive results from this difficult to treat patient population would provide provide compelling evidence of psilocybin's utility for treating various mental disorders. The Imperial College London is one of the top 10 ranked Universities in the world (ranked #2).

Carhart-Harris and Nutt have previously published 2 fMRI studies detailing psilocybin's effect on the brain and a recent theory of the entropic brain, the state of consciousness occasioned by the use of psychedelic substances.

Depression is common in men and women with post-traumatic stress disorder (PTSD). The trauma that caused PTSD also may cause depression (WebMD).  As of today, not a single pharmacological treatment has been developed specifically for PTSD (CNS Drugs. 2013 Mar;27(3):221-32).  A recent study that utilized an animal model of PTSD showed an extinction of "fear conditioning" and concluded that psilocybin "and similar agents, should be explored as potential treatments for post-traumatic stress disorder and related conditions" (Exp Brain Res. 2013 Aug;228(4):481-91). A study published in 1968 demonstrated the effectiveness of psilocybin for PTSD (Ind Med Surg. 1968 May;37(5):347-50).  Since publication of this 1968 study, new laws have made further research into the use of psychedelics nonexistent until recently.

Commenting on this situation, Dr Nutt, in the recent Guardian article referred to above, stated:

"It was unquestionably one of the most effective pieces of disinformation in the history of mankind," says Nutt. "It led to a lot of people believing these drugs were more harmful than they were. They are not trivial drugs, but in comparison with drugs that kill thousands of people a year, like alcohol, tobacco and heroin, they have a very safe track record and, as far as we know, no one has died."

There now exists an abundance of information to support and an abundance of need for a Clinical Trial utilizing psilocybin to treat PTSD.  The organizations that would be expected to take the lead in this research is logically the Department of Defense and the Veteran's Administration.

It is time for  the Department of Defense and the Veterans Administration ("We must do all we can to deliver the high-quality care our service members and veterans have earned and deserve.”) to stop talking the talk about trying to do everything they can to treat PTSD and to start walking the walk by leading the way in initiating Clinical Trials utilizing psilocybin in a therapeutic setting to treat PTSD.

Clinical Trials utilizing psilocybin

Currently there are 14 Clinical Trials listed in various stages of progress (below).  For a dynamic link to current psilocybin related Clinical Trials, click here.

UW Psilocybin Pharmacokinetics Study
The objective of this Phase I clinical trial is to determine the pharmacokinetics of oral doses of psilocybin in normal, healthy adults. The study is performed in support of Phase II and Phase III studies of psilocybin for the treatment of refractory anxiety associated with incurable cancer, as well as other possible indications. Psilocybin is at present not an FDA-approved drug.
University of Wisconsin

Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators
This is a double-blind placebo-controlled study investigating the acute and persisting effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes, and brain functioning.
Johns Hopkins University

Psilocybin-facilitated Smoking Cessation Treatment: A Pilot Study 
We propose to examine psilocybin administration combined with a structured smoking cessation treatment program in nicotine dependent individuals in order to provide preliminary data on the efficacy of this combined treatment in smoking cessation treatment.
Johns Hopkins University

Pilot Study: Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators
This is a pilot study to finalize methods for a larger study being planned for the future. This research is being done to characterize performance of tasks, brain functioning, and the effects of psilocybin in individuals with a long-term meditation practice.
Johns Hopkins University

Effects of Psilocybin in Advanced-Stage Cancer Patients With Anxiety 
The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center is conducting a study designed to measure the effectiveness of the novel psychoactive medication psilocybin on the reduction of anxiety, depression, and physical pain.
UCLA

Psilocybin-Assisted Psychotherapy for Anxiety in People With Stage IV Melanoma 
This study is to find out about whether two sessions of psilocybin-assisted psychotherapy are safe and will help people who are anxious as a result of having stage IV melanoma and will involve two sessions of psychotherapy combined with either 4 or 25 mg psilocybin.
MAPS

Effects and Therapeutic Potential of Psilocybin in Alcohol Dependence
This trial is an open-label pilot study (N = 10) designed to assess the effects of psilocybin in alcohol dependent participants, demonstrate the feasibility of the integrated behavioral/pharmacologic intervention, and provide preliminary outcome and safety data.
University of New Mexico

Psilocybin-facilitated Treatment for Cocaine Use 
The primary purpose of this study is to evaluate the feasibility and estimate the efficacy of psilocybin-facilitated treatment for cocaine use. We also will monitor the impact of psilocybin-facilitated treatment on the use of other drugs and outcomes relevant to cocaine involvement (e.g., criminal involvement).
University of Alabama at Birmingham

Psychopharmacology of Psilocybin in Cancer Patients 
This research is being done to study the psychological effects of psilocybin in cancer patients. Psilocybin is a naturally occurring substance found in some mushrooms that some cultures have used for centuries in religious practices.
Johns Hopkins University

Psilocybin Cancer Anxiety Study
The primary objective of this double-blind, placebo-controlled pilot study is to assess the efficacy of psilocybin administration (4-phosphoryloxy-N,N-dimethyltryptamine), a serotonergic psychoactive agent, on psychosocial distress, with the specific primary outcome variable being anxiety associated with cancer. Secondary outcome measures will look at the effect of psilocybin on symptoms of pain perception, depression, existential/psychospiritual distress, attitudes towards disease progression and death, quality of life, and spiritual/mystical states of consciousness.
New York University School of Medicine

A Double-Blind Trial of Psilocybin-Assisted Treatment of Alcohol Dependence 
Several lines of evidence suggest that classic hallucinogens such as psilocybin can facilitate behavior change in addictions such as alcohol dependence. The proposed investigation is a multi-site, double-blind active-controlled trial (n = 180, 90 per group) contrasting the acute and persisting effects of psilocybin to those of diphenhydramine in the context of outpatient alcoholism treatment.
University of New Mexico

Psilocybin and Spiritual Practice 
This study will investigate the effects of psilocybin dose and the frequency and intensity of support activities for spiritual practice (e.g., meditation) on a battery of attitudinal and behavioral outcome measures in 75 healthy volunteers who are interested in pursuing a program of spiritual practices with the intention applying spiritual insights and knowledge to everyday life.
Johns Hopkins University

Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion 
The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders.
Johns Hopkins University

Effects of Hallucinogens and Other Drugs on Mood and Performance 
This non-treatment study will investigate the effects on mood and performance caused by hallucinogens and other psychoactive compounds.
Johns Hopkins University