Public Health Service Approves Amended Protocol

On February 25, 2015, in a letter dated February 11, the U.S. Public Health Service (PHS) cleared the revised protocol for our planned study of smoked marijuana for symptoms of PTSD in 76 U.S. veterans. The first historic approval from PHS for the study came in March 2014. The protocol was amended for our successful grant to the Colorado Department of Public Health and Environment, which has awarded more than $2.1 million to MAPS for the study. The revised protocol includes an additional research site at Johns Hopkins University led by Co-Investigator and Site Principal Investigator (PI) Ryan Vandrey, Ph.D.; a private practice site for Co-Investigator and Site PI Sue Sisley, M.D.; the addition of Marcel O. Bonn-Miller, Ph.D., as Coordinating PI; and the addition of Co-Investigator Paula Riggs, M.D., to help ensure scientific integrity for the study. We are currently waiting for NIDA to provide information about the cost and availability of marijuana needed for the study. In addition, the study has been submitted for approval to the U.S. Food and Drug Administration and three Institutional Review Boards. The Johns Hopkins group has already received its Schedule I license from the Drug Enforcement Administration; Dr. Sisley will apply after the other approvals are in place. Once these final approvals are received, the study will be cleared to proceed.