http://www.maps.org/images/mapslogo-sm.gif http://www.maps.org/ 50 50 Psychedelic Research News http://www.maps.org/ Psychedelic Research News en-us editor@maps.org webmaster@maps.org Fri, 10 Feb 12 14:17:31 -0600 http://www.maps.org/media/view/amendment_to_ibogaine_addiction_study_approved_by_review_committee/ http://www.maps.org/media/view/amendment_to_ibogaine_addiction_study_approved_by_review_committee/#When:16:30:28Z 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. http://www.maps.org/media/view/new_zealand_observational_study_of_ibogaine_treatment_for_addiction_approve/ http://www.maps.org/media/view/new_zealand_observational_study_of_ibogaine_treatment_for_addiction_approve/#When:16:31:32Z 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. http://www.maps.org/media/view/clinical_team_prepares_protocol_for_new_study_of_ibogaine_treatment_for_add/ http://www.maps.org/media/view/clinical_team_prepares_protocol_for_new_study_of_ibogaine_treatment_for_add/#When:19:39:17Z On October 17, 2011, the lead investigators for MAPS’ ibogaine research program held a conference call to discuss the next steps for our new observational study of ibogaine treatment for addiction in New Zealand. Thomas Kingsley Brown, Ph.D., who leads our U.S.-based study of independent ibogaine clinics in Mexico, and Geoff Noller, Ph.D., who will lead the new study, shared perspectives and lessons from ibogaine therapy research in order to guide the development of the new study protocol. 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. The clinical team will submit the protocol and other documents to the Ethics Committee by the end of October. Since this will be an observational study (as opposed to clinical) 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 may be used to make a case for a possible future clinical study (see our original ibogaine Request for Proposals). http://www.maps.org/media/view/observational_study_of_ibogaine_treatment_for_addiction_enrolls_final_subje/ http://www.maps.org/media/view/observational_study_of_ibogaine_treatment_for_addiction_enrolls_final_subje/#When:19:38:20Z The 30th and final subject was enrolled in our ongoing observational study of ibogaine treatment for addiction on August 29, 2011. This final subject has completed treatment at an independent ibogaine clinic in Mexico and will be evaluated for addiction and quality of life for 12 months. As of October 20, 2011, 28 subjects have completed their three-month follow-up interviews, and 20 have completed the six-month follow-up interviews. Given the increasing numbers of people around the world seeking ibogaine treatment for drug addiction, this study aims to gather evidence about the safety and effectiveness of the treatment and to compare different approaches to that treatment. Thomas Kingsley Brown, Ph.D., the lead investigator for the study, will be speaking about the goals and progress of MAPS’ ibogaine research program on Saturday, December 10 at Cartographie Psychedelica, our 25th anniversary conference in Oakland, CA. http://www.maps.org/media/view/new_study_of_ibogaine_treatment_for_addiction_planned_for_new_zealand/ http://www.maps.org/media/view/new_study_of_ibogaine_treatment_for_addiction_planned_for_new_zealand/#When:21:54:25Z MAPS has agreed to donate $15,000 to a new observational study of ibogaine treatment for addiction to take place in New Zealand, under the direction of Principal Investigator Geoff Noller, Ph.D., Research Fellow in Psychological Medicine at the University of Otago, NZ. This will be an investigator-sponsored study conducted with assistance from MAPS, and has been made possible by a generous $25,000 grant for ibogaine research from Matt and Kristi Bowden of Stargate International. This study will complement our ongoing ibogaine research program in Mexico, to which the remaining $10,000 of the Bowdens’ donation will be allocated. Like our other observational ibogaine studies, this research will investigate the long-term effects of ibogaine therapy at independent treatment centers, perhaps up to three different New Zealand clinics. This data may be used to make a case for a possible future clinical study and to evaluate differences in treatment approach and effectiveness between clinics. We are expecting to submit study documents to a New Zealand ethics committee this summer, and anticipate initiating the study in late Summer or early Fall. http://www.maps.org/media/view/long-term_ibogaine_treatment_for_addiction_outcome_study_progresses/ http://www.maps.org/media/view/long-term_ibogaine_treatment_for_addiction_outcome_study_progresses/#When:22:35:36Z As of March 1, 2011, MAPS’ observational study of the long-term efficacy of ibogaine-assisted therapy for drug addiction has enrolled 16 out of 30 subjects. All participants in this study have already received ibogaine-assisted therapy at one of two independent treatment centers in Mexico, and the study is an attempt to evaluate the quality and duration of their treatment outcomes. The rationale for this study is based on the increasing numbers of people turning to ibogaine and ibogaine-assisted therapy for addiction treatment despite its high level of risk and little scientific knowledge about its long-term effectiveness. Over the course of the study, MAPS researchers use the Addiction Severity Index (ASI) to evaluate patterns of drug use including addictive behavior and overall quality of life. We are also using the States of Consciousness Questionnaire (SOCQ) to determine whether there is a correlation between the depth or intensity of the ibogaine experience and the duration of its therapeutic effects. The study also involves random drug testing of subjects to correlate data from the ASI with the results. A database is also currently under construction for managing and analyzing study data. MAPS is also offering a $25,000 matching grant to a research team interested in conducting clinical trials with ibogaine for drug addiction. Interested teams with the qualifications and resources necessary for conducting clinical drug trials may apply by responding to the questions listed in the request for proposals and submitting them to valerie@maps.org. http://www.maps.org/media/view/maps_offers_25000_for_clinical_trial_of_ibogaine/ http://www.maps.org/media/view/maps_offers_25000_for_clinical_trial_of_ibogaine/#When:00:40:20Z On December 17, 2010, MAPS Deputy Director Valerie Mojeiko released a request for proposals for clinical studies with ibogaine. While MAPS is currently sponsoring an ongoing observational study of ibogaine treatment for opiate addiction, the current request for proposals (RFP) is seeking a research team interested in conducting clinical trials. While observational studies are useful for establishing links between ibogaine and treatment outcomes, clinical studies allow investigators to make stronger claims about the role of the drug in producing the observed changes. In the current RFP, MAPS is offering a matching grant of $25,000 to one team of scientists who can provide an additional $25,000 or more for the study. MAPS will award the grant to a team with the credentials and resources to conduct a clinical trial of ibogaine, and which has the ability to navigate the required regulatory hurdles. The team must also be willing to make all study data public and to seek publication of the results. Interested parties may apply by responding to the questions listed in the RFP and submitting them to valerie@maps.org. http://www.maps.org/media/view/fifth_subject_enrolled_in_ibogaine_study_protocol_amended/ http://www.maps.org/media/view/fifth_subject_enrolled_in_ibogaine_study_protocol_amended/#When:21:44:53Z 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. http://www.maps.org/media/view/valerie_mojeiko_presents_at_ibogaine_conference_in_barcelona_oct._13-16/ http://www.maps.org/media/view/valerie_mojeiko_presents_at_ibogaine_conference_in_barcelona_oct._13-16/#When:03:12:31Z From Oct. 13–16, MAPS Deputy Director Valerie Mojeiko will participate in an international ibogaine conference in Barcelona. She will speak about MAPS’ ibogaine outcome study. The workshop is organized by the International Center for Ethnobotanical Education, Research and Service, whose executive director is Ben De Loenen, the filmmaker of “Ibogaine Rites of Passage.” Presenters include Kenneth Alper, M.D., Jeff Kamlet, M.D., Rakefet Rodriguez, M.D., Antoni Aguilar Chastellain, M.D., Cleuza Canan, and Anwar Jeewa. http://www.maps.org/media/view/first_two_subjects_enroll_in_ibogaine_outcome_study/ http://www.maps.org/media/view/first_two_subjects_enroll_in_ibogaine_outcome_study/#When:02:59:15Z On Sept. 27, the first two subjects enrolled in our new ibogaine study at Pangaea Biomedics, a treatment facility in Playas de Tijuana, Mexico. It is led by Principal Investigator Valerie Mojeiko and co-investigator Thomas Kingsley Brown, Ph.D. The researchers are collecting data from opiate-dependent subjects for one year after ibogaine-assisted detoxification to evaluate the long-term outcomes of ibogaine treatment. Brown met with both subjects and administered the Subjective Opiate Withdrawal Scale and the Addiction Severity Index (ASI). Both subjects are happy to participate, Brown said. One subject had difficulty answering all of the ASI questions because of withdrawal symptoms, so the interview was finished by phone Sept. 29. “It feels great to have the first two subjects enrolled and to be doing this work,” Brown said. The entire study will enroll 30 subjects and follow them for a year after treatment.