NEW YORK (MainStreet) The first federal study on the efficacy of treating post traumatic stress disorder (PTSD) with marijuana has just been given the green light to proceed to the next regulatory hurdle approval by the DEA. That said, the approval by the federal Department of Health and Human Services (HHS) last week is considered by many to be not only a welcome surprise but a revolutionary advance through a traditional stumbling block to this and similar trials.
The main holdup? The study proposal from the University of Arizona had been cleared over a year ago by the federal Food and Drug Administration (FDA) but was stymied by lack of access to the only federally legal marijuana source in the lower 48 a grow farm in Mississippi.
The proposal, helmed by University of Arizona Professor Suzanne Sisley, aims to measure the efficacy of the drug on PTSD suffered by veterans treated via five different potencies of marijuana delivered via smoked or vaporized sources.
50 veterans will participate in what is being widely hailed as a groundbreaking research effort. Up to 20% of veterans who served in Iraq or Afghanistan are presumed to be affected by the trauma induced disorder, and more than 7.7 million Americans currently suffer with the diagnosis but almost no easy relief.
PTSD is one of a growing list of neurological if not formerly labelled "psychiatric" conditions for which cannabinoids have been widely, if unofficially used to treat symptoms which often are unresponsive to all other forms of treatment. Marijuana, despite many claims by detractors over the years, is still largely considered by users or those who advocate its medicinal use, as the only substance which provides symptomatic relief without either the toxicity or side effects found in all other treatments for these conditions.
The trial in Arizona is the latest of what have been widely watched and reported on federal trials of cannabinoids in plant or drug form for different uses over the past decade in particular.
A high profile European and American trial of an Israeli cannabinoid based drug is due to begin testing later this year. That drug is used primarily to treat physical brain injuries. PTSD can be caused by a variety of factors, with both physical and psychological causes if not triggers.
PTSD also, like many neurological conditions where marijuana has shown to be efficacious via both clinical studies if not unregulated/unprescribed patient use, is one with no formal diagnosis, no cure and no easily medicated outcome. Other drugs used in the past as part of therapy for this devastating condition come with a long list of serious and long lasting complications, including not only inefficient symptom relief but impaired cognition if not addiction.
Many in the veterans' community as well as the medical community have pushed for a study like this for years, noting that the FDA in particular has been more willing to test even MDMA (also known as Ecstasy) than marijuana on patients reporting or diagnosed with PTSD in the past. This despite widely known efficacy of cannabinoids to reduce anxiety and depression that are the common symptoms of post traumatic distress disorder.
The American Medical Association has also long called for an end to federal regulation preventing doctors from even proscribing marijuana for legitimate treatment in places where the drug is still outlawed by state law. This is the hurdle that the Arizona study is now in the process of clearing, but it is a lengthy process. Medical researchers on federally funded trials must still, as they will have to proceed in Arizona where medical marijuana is not approved for dispensation, conduct research only by obtaining the drug from the single, federally approved dispensary in the United States.
The other large and enduring issue faced by trials of this nature is of course the changing interest in marijuana if not cannabinoids for neurological and psychiatric research, if not the "chemical warfare" waged against these substances from many different legal, regulatory and industry sources since the early part of the 20th century.
Federal classification of marijuana is still as a Schedule I drug, which means it is officially, according to the U.S. government at least, considered a drug with a high abuse potential and no accepted medical uses. This despite many trials of the same for a variety of conditions, if not the availability of chemically similar legal substitutes to treat everything from cancer and AIDS to Parkinson's and multiple sclerosis.
The best known and most widely available cannabinoid containing drug is Marinol, made of synthesized tetrahydrocannabinol (THC). Marinol is now labelled a Schedule III drug. Other pharmaceuticals on the market, such as Cesamet (Nabilone), also mimic the action of THC and are used widely for the treatment of Parkinson's in particular; however, Cesamet drug is restricted under Schedule II FDA regulation.
The Arizona study which still needs a final federal agency approval to proceed again moves forward, as the cornucopia contained in the cannabinoid medicine chest continues to swing ever wider to include more formerly intractable if not hard to treat conditions.
--Written by Marguerite Arnold for MainStreet