On Nov. 22, 2010, the fifth subject was enrolled in our observational study of ibogaine treatment for opiate addiction. On Dec. 2, the research team, led by Principal Investigator (and MAPS Deputy Director) Valerie Mojeiko and Co-Investigators Thomas Kingsley Brown, Ph.D., Meg Jordan, Ph.D., R.N., and Rishi Karim Gargour, M.A., submitted an amendment to the protocol to the Human Resources Review Committee (HRRC) at the California Institute for Integral Studies, which was soon after approved on December 9. The amendment requested five changes to the protocol:
1) Increase the number of subjects from 20 to 30. This will provide more statistical power to the final analysis.
2) Add an additional site for data collection. We are adding a second clinic, also based just south of the San Diego border in Mexico, to increase the speed of subject recruitment. This clinic is similar in many ways to the other clinic from which patients are being recruited, but we will also analyze data from each clinic site separately to try to detect differences.
3) Add drug testing. Drug testing will allow us to verify information provided subjects about their substance use. Subjects will be compensated for their time spent visiting the testing center.
4) Utilize the Beck Depression Inventory. This measure, which has been used in other addiction studies of ibogaine, will track depression over the course of the study. Treatment providers have observed relief from depression in some of their clients, and this inventory will attempt to measure this purported effect of ibogaine.
5) Utilize the Trait Emotional Intelligence Questionnaire, Short Form (TEIQ-sf). This measure will allow us to explore the role that emotional intelligence may play in addiction recovery.
On Dec. 10, Valerie Mojeiko and Thomas Kingsley Brown conducted a site visit of the second clinic. They were impressed with the medical procedures used by the clinic and have decided to enroll subjects from that clinic in our study.