Boulder: Fifth Subject Treated; DEA Approves Expanded Protocol
On December 20, 2013, the fifth subject received their first experimental treatment in our ongoing study of MDMA-assisted psychotherapy for PTSD in Boulder, Colorado. The same day, the U.S. Drug Enforcement Administration approved an amended protocol for the study (which we submitted on November 18) adding five subjects for a third dose group of 100 mg, increasing the size of study from 12 to 17 subjects. The second subject has dropped out after one treatment session due to scheduling difficulties, and reported that they felt somewhat improved. The amendment was approved by an independent review board on November 6, and cleared the 30-day FDA review period on November 25.