Related<\/span>\n\t\t\t\tFloatin\u2019 in ecstasy: Veterans suffering from PTSD may soon find help from an unlikely source<\/h3>\n\t\t\t\t\t\t\t\t\t
MDMA was recently designated by the U.S. Food and Drug Administration as a \u201cbreakthrough therapy\u201d for treatment of post-traumatic stress disorder.<\/p>\n\t\t\t\t\t\t\t<\/div>\n\t\t<\/a>\n\t<\/aside>\n\t\n\n\n
But investigation into similar potential uses for cannabis \u2014 long praised by supporters for pain management and mood stabilization \u2014 has proven much more difficult, largely because of more restrictive federal rules over its handling and experimentation.<\/p>\n\n\n\n
It\u2019s classified as a schedule 1 drug, alongside heroin and cocaine, severely limiting how it can be purchased and used for scientific studies. Congressional efforts to change that and broaden medical research have stalled in recent years.<\/p>\n\n\n\n
Sisley\u2019s effort was formally launched two years ago after getting FDA approval and $2.1 million from the Colorado Department of Public Health and Environment. It\u2019s located in Arizona but sponsored by the California-based Multidisciplinary Association for Psychedelic Studies.<\/p>\n\n\n\n
The study has been billed as potentially the first definitive U.S. research on whether marijuana can help manage veteran\u2019s PTSD, and has received high-profile backing from the American Legion and other veterans organizations.<\/p>\n\n\n\n
But it has faced numerous problems. Getting federal approval took five years. Officials at Johns Hopkins University in Maryland withdrew from the study shortly after its formal start, leaving Sisley with a single Arizona site to monitor participants.<\/p>\n\n\n\n
She says researchers have screened more than 4,000 state veterans but managed to enroll only 22 of the 76 needed for a full study. Criteria for applicants is restrictive: veterans with service-connected chronic post-traumatic stress disorder available for a 14 weeks of initial monitoring and six months of follow-up.<\/p>\n\n\n\n
\u201cFor the last two years, we\u2019ve reached out to every veterans service organization and every post in the state,\u201d Sisley said. \u201cWe\u2019ve depleted that source. And it\u2019s still not enough.\u201d<\/p>\n\n\n\n
She believes that dozens of veterans who would qualify for the study are among the thousands of patients at the nearby Phoenix VA Medical Center, and has lobbied administrators for two years to let her discuss the work with physicians there.<\/p>\n\n\n\n
They\u2019ve consistently denied those requests. Letters to top VA health officials and VA Secretary David Shulkin have not received any response.<\/p>\n\n\n\n
VA officials have consistently cited federal rules barring their physicians from discussing marijuana as a possible treatment alternative, even in states where the drug is legal for medicinal or recreational purposes.<\/p>\n\n\n\n
Sisley regularly responds with a Veterans Health Administration memo from March 2012 which states that none of the rules \u201cpreclude VA clinicians, in the normal course of their clinical duties, from discussing specific research studies with their patients where appropriate, and referring them to a non-VA investigator for more information about a non-VA study.\u201d<\/p>\n\n\n\n
At a White House press conference in May, Shulkin was asked about easing the rules for medical research on cannabis to help broaden treatment options for veterans.<\/p>\n\n\n\n
\u201cRight now, federal law does not prevent us at VA to look at that as an option for veterans,\u201d he said. \u201cI believe that everything that could help veterans should be debated by Congress and by medical experts.<\/p>\n\n\n\n
\u201cIf there is compelling evidence that this is helpful, I hope the people take a look at that and come up with the right decision, and then we will implement that.\u201d<\/p>\n\n\n\n
Sisley insists she is trying to provide that evidence, and has sharply criticized local and federal VA officials for not offering more assistance. Cashour responded that VA is not to blame.<\/p>\n\n\n\n
\u201cIf the researcher is truly interested in finding veterans for her study, she should spend more time recruiting candidates and less time writing letters to the media,\u201d he said.<\/p>\n\n\n\n
The study has employed a full-time recruiter and again petitioned local veterans groups for assistance, but Sisley believes VA cooperation could solve the problem much more quickly.<\/p>\n\n\n\n
If new participants can\u2019t be found by Oct. 1, she said, researchers will either have to shut down the work or expand the study parameters to include non-veterans. Neither of those moves will provide the veteran-specific PTSD data she was hoping to collect.<\/p>\n\n\n\n
\u201cIt was a seven-year saga with federal regulations just to get the study to this point,\u201d she said. \u201cI don\u2019t want to see that lost.\u201d<\/p>\n\n\n\n
For more information on the study, visit the MAPS web site<\/a>. <\/p>\n\n\n\n