U.S. Boulder Study: DEA Approves Schedule I License for Study Physician
On February 21, 2013, the U.S. Drug Enforcement Administration approved the Schedule I license for the psychiatrist for our new study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The Schedule I license allows the study psychiatrist to store and administer the MDMA to be used in the study. The license was issued just one day after a favorable recommendation was sent to the DEA national headquarters by the agency’s Denver field office. We have now obtained all necessary approvals and can initiate the study months sooner than anticipated.
In contrast, we waited about five months for the DEA issue a Schedule I license to Dr. Michael Mithoefer, the lead investigator of our ongoing study in U.S. veterans, and seven months to issue his Schedule I license for our therapist training protocol. According to MAPS executive director Rick Doblin, Ph.D., “When DEA headquarters processes a Schedule I license for MDMA/PTSD research in just one day, anything seems possible.”