José Carlos Bouso | January 21, 2025
A study conducted in Catalonia by ICEERS and the Reus Hospital has published preliminary results showing how the use of low-dose ibogaine can reduce methadone tolerance in patients with opioid dependence. This innovative clinical trial seeks to offer therapeutic alternatives to the opioid epidemic that affects millions of people worldwide.
Opioid dependence is one of the most pressing global health challenges. In this context, the preliminary results of a clinical trial conducted by ICEERS, led by Dr. José Carlos Bouso in collaboration with the Servei de Drogodependències i Salut Mental of Reus Hospital, led by Dr. Tre Borràs and a multidisciplinary team of researchers, have been published. The study focuses on the use of ibogaine for the detoxification of methadone dependence.
This first publication presents preliminary results on the use of low doses of ibogaine to reduce methadone tolerance, opening new perspectives for the treatment of opioid dependence. The research is part of former ICEERS member Dr. Genís Oña’s doctoral thesis, directed by Dr. José Carlos Bouso and Dr. Teresa Colomina.
An innovative approach
Ibogaine, an alkaloid derived from the African plant Tabernanthe iboga, has been used for centuries in traditional healing ceremonies. Today, its potential to address substance use disorders is capturing the attention of the scientific community. This study takes an innovative approach by using a low dose (100 mg) of ibogaine, prioritizing safety and minimizing adverse effects.
The study, designed as a randomized, double-blind clinical trial, included 20 participants in methadone maintenance programs (MMP) in Catalonia. Two groups were established: in one, subjects received increasing doses of ibogaine, starting with 100 mg and increasing weekly until reaching 600 mg; in the other, the fixed dose of 100 mg was maintained. After each ibogaine administration, the methadone dose was halved until it was completely eliminated. Participants were randomly assigned to the groups. Participants were between 27 and 59 years old, with a gender distribution of 17 men and 3 women, reflecting the usual proportion in methadone maintenance programs in Spain. Prior to administration, psychometric evaluations, blood tests and electrocardiograms were performed to ensure safety. In this first publication, we present the results obtained with the 100 mg dose, which was the initial dose administered to all patients.
After administration, participants remained under observation for 24 hours in a hospital setting, with periodic monitoring of vital signs, electrocardiograms, and assessments of withdrawal symptoms using scales such as SOWS (Short Opioid Withdrawal Scale) and OWS (Opioid Withdrawal Scale). In addition, plasma samples were collected for metabolomic analysis.
Encouraging results
The study revealed key findings that could change the landscape of opioid dependence treatment:
- Significant reduction in methadone dosage. All participants achieved a 50% reduction in their daily methadone dose for one week after ibogaine administration. This result was particularly relevant given that the protocol allowed for adjustments in dose reduction according to individual needs. However, after the first administration, three subjects dropped out of the study: one, due to heroin use during the week following the first session, which represented a safety risk; a second, due to experiencing withdrawal after ibogaine administration, which led him to decide not to continue; a third, due to a significant increase in the QTc interval after administration, considered dangerous by the cardiology team.
- Control of withdrawal symptoms. Although withdrawal symptoms increased slightly at 12 hours after administration, participants reported an overall experience of relief and relaxation. Psychometric assessments showed that symptoms did not reach clinically significant levels.
- Safety and tolerability. No serious adverse events were reported. The most common side effects included fatigue, dizziness, and light sensitivity, all of mild to moderate intensity. However, one participant was excluded due to a significant prolongation of the QT interval on the electrocardiogram, underscoring the importance of cardiovascular monitoring. Furthermore, additional safety measures, such as the use of the Hospital Anxiety and Depression Scale (HAD) and the Brief Psychiatry Rating Scale (BPRS), were employed to monitor the emotional and psychopathological status of the participants. Both tools indicated that, in general, levels of anxiety, depression and psychopathological symptoms remained stable throughout the study, with no clinically significant changes, supporting the psychiatric safety of the treatment.
- Impact on energy metabolism. Metabolomic analyses showed changes in compounds related to cellular metabolism, such as a decrease in lactate and an increase in 2-oxo isocaproate. These results suggest that ibogaine could restore energy metabolism altered by chronic opioid use.
Social impact and sustainability
This approach represents a step towards more accessible and sustainable treatments for opioid dependence. By employing a low dose of ibogaine, the risk of serious adverse effects associated with high doses is reduced and resource use is optimized. In addition, the study used ibogaine extracted from Voacanga africana, a more sustainable source than Tabernanthe iboga, contributing to the preservation of this plant in its natural habitat.
The main conclusion of this study is that a low dose of ibogaine (100 mg) is safe and effective in significantly reducing methadone tolerance, facilitating its detoxification and decreasing the dose required during the week following administration. We are currently continuing with the one-year follow-up of the treated participants and are analyzing the results of the full study. We hope that by June of this year we will be able to present the final results of this promising study.
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