U.S. Boulder Study: Zoning Office Approves New Study Site
On October 16, 2012, the zoning office for the city of Boulder, Colorado, approved the business license for the site for our upcoming study of MDMA-assisted psychotherapy in Boulder. The local Drug Enforcement Administration field office required this approval before it would recommend that the DEA grant the study physician a Schedule I license, required before we can start screening subjects.
Once the business license is issued and the safe is relocated for the third time, the DEA will schedule a final inspection and hopefully grant the Schedule I license. Needing to comply with Boulder zoning regulations has delayed our estimated start date for the study by about six months, and we are hoping to start screening subjects in February 2013.
Additionally, from September 21-23, 2012, MAPS Director of Clinical Research Amy Emerson and Lead Clinical Research Associate Berra Yazar-Klosinski, Ph.D, visited the study site. They met with Principal Investigator Marcela Ot’alora, L.P.C., co-investigators, and other study staff to conduct a final training on the protocol and study documents, as well as to review our MDMA Investigator’s Brochure and new safety data from completed MAPS clinical trials.