U.S. Boulder Study: DEA Inspects Site, Delays Study Initiation

On July 31, 2012, an inspector from the U.S. Drug Enforcement Administration conducted the scheduled inspection of the site for our planned study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The inspection is required before the DEA will grant a Schedule I license to the study physician, which is required before we can initiate the study. The DEA contacted the local zoning office, which informed Principal Investigator Marcela Ot’alora, L.P.C., that a new business license is required for the building where the psychotherapy sessions will be conducted, delaying the study initiation by one or two months.

The existing business license for the Boulder study site is for an office on the same property but separate from the building where the MDMA-assisted psychotherapy sessions will be conducted. In order to conform to local zoning regulations, three new parking spots must be added and several appliances removed as the building used to be a rental unit. These modifications have now been completed and we are awaiting the new business license.