On May 4, 2010, Peter Gasser, M.D. submitted an amendment to our Swiss LSD/end-of-life anxiety study to his Ethics Committee (EC). The EC will meet on May 25 to evaluate the amendment. The amendment requests that we 1) include audio and video recording of the treatment sessions for later analysis, 2) add interim data analysis in order to get a sense of the safety and effectiveness of treatments before the study is over, and 3) make the protocol more flexible to meet the needs of the study population, which are people with advanced-stage cancer or other life-threatening diseases. Often these subjects have difficulties leaving home because of pain. As a result, we would like to expand some of the timelines in the current version of the protocol in order to be more flexible with the subjects.
Currently, the eighth subject out of 12 has been enrolled, with the eighth subject’s experimental treatment to take place soon. We are also adding a new clinical study assistant to the staff, Katharina Kirchner, M.A. of Switzerland. She will assist with data entry for this study and for our Swiss MDMA/PTSD study.