On November 1, 2011, an independent Ethics Committee granted conditional approval for MAPS’ ibogaine research program in New Zealand, pending the submission of a few final documents.
It was particularly important to meet this deadline because only a limited number of ibogaine treatments take place in New Zealand, and the lead investigator, Geoff Noller, Ph.D. will be able to maximize the treatments to be followed by starting the study as soon as possible once it is approved. Dr. Noller has received a verbal approval from the Ethics Committee, although he is still waiting to receive a formal letter in the mail.
The new study will take place at an independent ibogaine clinic in New Zealand, and will examine the safety and long-term effectiveness of ibogaine treatment for addiction severity and quality of life in 20 to 30 patients. Since this will be an observational study (which means that MAPS does not administer a drug in the study but only surveys people who have taken a drug in the past) the protocol does not need to pass through an additional review process, meaning that we can begin enrolling subjects as soon as the study clears the Ethics Committee. Data from this study and our ongoing study of Mexican ibogaine treatment centers under the direction of investigator Thomas Kingsley Brown, Ph.D., may be used to make a case for a possible future clinical study with ibogaine. Clinical studies, by contrast, are those in which researchers administer the drug or a placebo in a controlled setting and submit the data to the FDA.