The Pygmy tribes of Central Africa have known for centuries of a special plant with magical properties for medicinal purposes. The Bwiti utilized Ibogaine for spiritual as well as medicinal uses. Europeans discovered the substance via the French colonial expedition by the 1890s. In 1962 it was claimed by a Howard Lotsof that Ibogaine had anti-addictive properties while in France it was used as a stimulant. The U.S. Central Intelligence Agency (CIA) studied the substance in the 1950s. Ibogaine is currently not approved for any medical use.
Although not approved by any health authority to date, clinical trials involving the substance started by the 1990s—they were halted due to cardiotoxicity. Some claim a “vast uncontrolled experiment” occurs ongoing as some alternative medicine clinic uses the substance to treatment for addiction. Presently, clinical trials are underway in Brazil and TrialSite News will summarize these.
The investigational Product
Ibogaine is an alkaloid present in the bush Tabernanthe iboga (iboga), a plant from Central Africa traditionally used in countries such as Gabon and Cameroon. Animal studies and case series suggest that one or a few doses of ibogaine significantly reduce withdrawal symptoms and the intensity of use of various drugs, including opioids, psychostimulants, and alcohol. However, there are no controlled clinical studies that have explored these effects.
Although the medications currently used have some efficacy, the adverse effects and relatively long time of treatment are factors that may reduce patients’ motivation to continue taking the medication correctly
There are currently two active clinical studies reported in Clinicaltrials.gov that TrialSite News research was able to find. The first study is sponsored by the University of Sao Paulo. The sponsor will commence the study in 2020 with a planned conclusion in 2022. The first study centers on alcohol addiction afflicting 5% of the world’s adult population. Moreover, Brazil counts up to 10% of the population that may depend on alcohol.
The aim of the first study is to evaluate the safety, tolerability, and efficacy of increasing doses of ibogaine in 12 alcoholic patients. Each patient will be hospitalized for 20 days and receive 3 increasing doses of ibogaine. The first 3 patients will receive oral doses of 20 to 400 mg of ibogaine in an open-label design. If the 3 higher doses (240, 320 and 400 mg) are well tolerated, the next 9 volunteers will receive these doses or placebo randomly. The volunteers will also be evaluated 7, 14 and 21 days and 1, 3, 6 and 12 months after leaving the hospital to monitor the consumption of alcohol and other drugs.
Rafael dos Santos, PhD with the Departmento de de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo is the Principal Investigator. The Study Director is Jaime Hallak, PhD, Departamento de Neurociências e Ciências do Comportamento, Faculdade de Medicina de Ribeirão Preto, Universidade de São Paulo.
The second study, centering on methadone use, is sponsored by The International Center for Ethnobotanical Education, Research and Service (ICEERS), a non-profit organization dedicated to transforming society’s relationship with psychoactive plants. Study collaborators include the Multidisciplinary Association for Psychedelic Studies as well as University Rovira I Virgili, University of Madrid, Hospital University Sant Joan de Reus and the University of Sao Paulo. The study will commence this month and continue through 2020.
We are in the midst of an opiate crisis in the United States of unparalleled magnitude. 70,000 Americans die every year from a drug overdose—this is more than the Vietnam War. At least 2.4 million Americans struggle with opioid addiction according to the U.S. White House. at a cost of $504 billion to the society according to the White House report. This is a staggering statistic.
Many health systems treat opioid addiction with another opioid-based product that causes another addiction—Methadone, a long-acting opiate very difficult to detox from. Spain experienced a heroin epidemic in the 1980s and hence now has many methadone-dependent people. Many of these individuals have been on the substance for over a decade and a good number of them are relatively stable (e.g. work, family, housing) and decent health in comparison with heroin users.
The Phase II random controlled trial in collaboration with Sant Joan Hospital in Reus, Spain will include 20 patients on methadone maintenance programs. The patients will be randomized into two groups including 1) a group receiving 6 doses of 100mg of ibogaine, and 2) the other group receiving ascending doses of ibogaine (100-200-300-400-500-600).
Methadone use will be interrupted and for both groups, ibogaine will be administered when clinical symptoms of opioid withdrawal appear. After an ibogaine dose, when symptoms of withdrawal appear again, half of the methadone used last time will be administered. By doing so, methadone doses will be progressively reduced until no withdrawal symptoms appear.
In Spain, there is a lot of methadone dependent people in the aftermath of the heroin epidemic of the 1980s. Many have been dependent for more than 15 years and a number of them have a relatively stable life condition (have work, family, housing, etc.) and a relatively good health condition in comparison with current heroin users. This Phase-II RCT is a collaboration with the Sant Joan Hospital in Reus, Spain. Twenty patients on the methadone maintenance program will be recruited. Patients will be randomized into two groups: One receiving 6 doses of 100 mg of ibogaine; and the other one receiving ascending doses of ibogaine (100-200-300-400-500-600). Methadone use will be interrupted and for both groups, ibogaine will be administered when clinical symptoms of opioid withdrawal appear. After an ibogaine dose, when symptoms of opioid withdrawal appear again, half of the methadone dose used last time will be administered. By doing so, methadone doses will be progressively reduced until no withdrawal symptoms appear.
Jose Carlos Bouso, Ph.D., International Center for Ethnobotanical Education, Research and Service
Tre Borras, MD, Hospital University Sant Joan de Reus Study Director, Genis Ona, MSc, International Center for Ethnobotanical Education, Research and Service
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