On November 17, 2011, the second protocol amendment to our ongoing observational study of ibogaine treatment for addiction was approved by the Human Research Review Committee (HRRC) at the California Institute of Integral Studies (CIIS). The committee received the amendment on November 1. The purpose of this amendment was (a) to remove the control group, for which we were not able to recruit qualifying subjects; (b) add a data analysis plan to the protocol; (c) standardize the drug testing schedule so that all subjects undergo both hair and urine tests; (d) add two secondary objectives that analyze data from the drug tests and investigator ratings of well-being that have already been collected; and (e) make administrative updates such as changing the names of sections and measures. On August 29, we enrolled the 30th and final subject for this study, who will be evaluated for addiction and quality of life for a year. This study’s final visit is scheduled for September 2012.
Information has been collected for 18 out of 30 subjects in this study for their 3-month follow-up evaluations, and for 11 out of 30 subjects for their 6-month follow-up evaluation. In some cases, these data were based on reports from significant others of the subjects.