Ibogaine

Key Insights

• Ibogaine is not listed as a scheduled substance by the United Nations but is a controlled or illegal compound in many Western countries, with the notable exception of New Zealand.
• Ibogaine has the potential to decrease a patient’s misuse of opioids, cocaine and alcohol. It reduces symptoms of withdrawal after the administration of a single dose.
• Ibogaine treatment is being offered in several countries around the world, with (average) costs ranging from $2,500 to $10,000 per treatment.

Ibogaine is a naturally occurring psychoactive compound derived from plants such as the roots of the iboga tree (Tabernanthe iboga), though it can also be chemically synthesised. It has been used for over 100 years by the Bwiti tribe of Gabon and holds particular spiritual significance for practitioners of the Bwiti religion in West Africa. Ibogaine also has an established history as a treatment for substance use disorders, particularly in South American countries such as Mexico and Guatemala, where it operates in a legal grey area, being unregulated but not illegal.

Case reports and open-label studies around the world where its use is permissible have found that ibogaine appears to have the potential for rapidly relieving individuals from the grips of addiction and withdrawal. It is currently being researched for the treatment of methadone withdrawal in Spain, alcoholism in Brazil, and opioid withdrawal in the UK and the Netherlands. However, ibogaine’s relatively unsafe profile, leading to at least 20 deaths in the past 30 years, has prompted researchers to research alternatives that offer the benefits without the cardiac risks.

Index of the Ibogaine Compound Page

Commercial Development and Availability of Ibogaine

This landscape gives an overview of the availability of ibogaine as a treatment, focussing on the medical aspect (versus recreational/growth). It covers the latest in commercial developments, legal perspectives, and patents. We end the section with a reflection on the opportunities and challenges facing ibogaine as a therapeutic.

As research continues to demonstrate ibogaine’s potential as an anti-addictive compound, several companies and organisations have begun ramping up efforts to further develop ibogaine or related substances into approved medications. However, ibogaine remains unavailable in most countries outside of underground settings due to its designation as an illegal Schedule I substance. This section explores current commercial development initiatives, legal status, and treatment availability involving ibogaine.

In recent years, a fledgling pharmaceutical industry has emerged seeking to unlock the therapeutic potential of psychedelic compounds like ibogaine. Companies are pursing both above-board clinical trials and drug development pathways as well as underground treatment models.

Pharmaceutical Companies Developing Ibogaine

DEMERX

DemeRx IB, an atai Life Sciences platform company, is actively working on developing ibogaine for treating opioid use disorder (OUD). The company’s commitment to medical-model drug development pathways sets it apart in the field of psychedelic therapeutics. In 2021, DemeRx initiated a Phase 1/2a clinical trial of ibogaine hydrochloride (DMX-1002) for OUD. This trial commenced enrollment and dosing of recreational drug users and healthy volunteers at the Manchester clinical unit of MAC Clinical Research in the UK, with a focus on assessing safety, tolerability, pharmacokinetics, and efficacy. The Phase 1/2a trial is crucial for providing safety data and informing future studies in patients with OUD

In August 2023, DemeRx reported data from the Phase 1 study of DMX-1002. The study achieved plasma concentrations and psychedelic experiences consistent with previous ibogaine studies. The treatment-related adverse events and side effects were generally mild to moderate in severity, with no serious adverse events reported. These results enable discussions with regulatory authorities regarding the progression of DMX-1002 into a proof-of-concept study in OUD. Notably, in November 2023, atai Life Sciences acquired all remaining shares of DemeRx IB, integrating DMX-1002 as a wholly-owned asset and streamlining the company’s clinical and administrative operations

The approval for the Phase I/IIa clinical trial allows DemeRx to study ibogaine in ‘healthy normal’ participants before moving to a second trial stage with opioid-dependent patients. The trial will pause to allow the MHRA to evaluate human safety data and nonclinical study results. Approximately 110 patients will be recruited for the trial, including 30 recreational drug users in Stage 1 and 80 opioid-dependent patients in Stage 2​.

MIND MEDICINE

MindMed is a publicly-traded biotech company developing 18-methoxycoronaridine (18-MC), an ibogaine analogue, into an FDA-approved drug for opioid withdrawal and other addictions. The company believes that 18-MC could preserve ibogaine’s anti-addictive properties while eliminating cardiotoxic side effects. In 2021, MindMed completed the first Phase 1 clinical trial of 18-MC in Australia, which demonstrated its safety and tolerability in healthy volunteers across various doses.

The company initially planned to launch a Phase 2 trial for opioid withdrawal in 2022 but (indefinitely) delayed further trials because of additional preclinical studies that were requested by the FDA before they could proceed. This further request, coupled with tightening finances has resulted in a current stall of developments by the company into 18-MC.

DELIX THERAPEUTICS

Delix Therapeutics, a company specializing in neuroplasticity-promoting therapeutics, has made progress in its clinical research in 2023. They initiated a Phase I trial for DLX-001, a non-hallucinogenic psychoplastogen, and completed dosing for the first cohort. The trial did not report any significant adverse events or psychotomimetic effects, allowing for a dosage increase in the next cohort. The trial also confirmed the oral administration’s viability and pharmacokinetic properties of DLX-001. Additionally, Delix Therapeutics has expanded its research team and formed partnerships to support drug discovery efforts.

The trial’s findings also indicated a close alignment between predicted and observed pharmacokinetic parameters in human subjects, suggesting the potential for preclinical findings to be replicated in clinical settings. Additionally, the trial established the viability of oral administration of DLX-001, determining its bioavailability and oral pharmacokinetic characteristics. The novelty of DLX-001’s mechanism of action has been a point of interest (and much discussion), especially as it initiates a new paradigm in the treatment of depression without causing hallucinatory responses.

MULTIDISCIPLINARY ASSOCIATION FOR PSYCHEDELIC STUDIES (MAPS)

The Multidisciplinary Association for Psychedelic Studies (MAPS), a non-profit, has contributed to the early research on ibogaine, particularly in the context of treating opioid addiction. MAPS completed two observational studies on the long-term effects of ibogaine treatment at independent ibogaine treatment centers in Mexico and New Zealand. These studies were published in the American Journal of Drug and Alcohol Abuse, emphasizing ibogaine’s potential as a treatment for opioid dependence and advocating for further investigation through rigorously controlled studies.

In the Mexico study, 30 participants who had not found success with other treatments received ibogaine treatment. This study reported significant reductions in opioid withdrawal symptoms and drug use. Specifically, 12 out of 30 participants experienced a 75% reduction in drug use 30 days following treatment, and 33% reported no opioid use three months later. However, it’s important to note that this study had limitations, such as a small number of participants, no control group, and reliance on self-reporting.

The New Zealand study also demonstrated the efficacy of ibogaine in reducing opioid withdrawal symptoms and aiding in either complete cessation or sustained reduction of opioid use for up to 12 months following a single treatment. This study included 14 participants, with one participant disqualified and another who died during treatment, highlighting the need for careful monitoring and consideration of potential risks.

Psychedelic Clinics/Retreat Centres Offering Ibogaine Treatment

While pharmaceutical companies pursue formal drug development pathways, dozens of psychedelic clinics and retreat centers have already begun offering ibogaine treatments for addiction across the globe. These (underground) providers operate in countries where ibogaine is (sometimes) illegal but not criminalized for personal use.

Popular ibogaine retreat locations include Mexico, Canada, Costa Rica, and the Caribbean Islands. Many advertise themselves as medically supervised wellness centers focused on holistic healing. However, regulation and medical standards vary greatly between different providers. Some employ physicians, nurses, and credentialed therapists to monitor treatments, while others rely on coaches with no formal clinical training.

At licensed clinics, patients typically receive a comprehensive medical screening to check for ibogaine contraindications before undergoing an ibogaine “flood” dose session. This is followed by integrative aftercare services like psychotherapy and mindfulness training to complement ibogaine’s biological anti-addictive effects with emotional healing. The cost per treatment ranges from $2,500 to over $10,000 depending on the program’s length and luxury.

While retreat-style ibogaine treatments remain unregulated, they demonstrate continued interest in ibogaine’s therapeutic potential despite its illegal status. Some view such clinics as pioneering an underground model that could inform future legal medically-supervised protocols. However, others argue that lax medical oversight at some facilities poses unacceptable safety risks to vulnerable patients.

BEOND

Beond, as one of the psychedelic clinics offering ibogaine treatment, stands out in the current landscape of providers. Nestled in a serene environment, Beond caters to individuals seeking relief from various addictions through the therapeutic use of ibogaine. Unlike some retreat centers, Beond places a strong emphasis on the safety and efficacy of its treatments. This commitment is reflected in their rigorous medical screening process, which is designed to identify any contraindications to ibogaine use, ensuring that the treatment is as safe as possible for each patient.

At Beond, the ibogaine experience is not just about the administration of the substance; it’s about a holistic healing journey. The clinic offers a comprehensive program that includes a high-dose ibogaine session, often referred to as a “flood” dose, which is believed to reset addiction patterns and alleviate withdrawal symptoms. Following the initial treatment, Beond provides an integrative aftercare program. This program typically includes psychotherapy, mindfulness training, and other wellness practices aimed at reinforcing ibogaine’s biological effects with emotional and mental healing. The goal is not just to treat addiction but to foster a transformative experience that can lead to long-term recovery and personal growth. While the cost of treatment at Beond can vary, it reflects the clinic’s commitment to providing a high-quality, comprehensive service that covers all aspects of the healing process.

ROOT HEALING

Root Healing in Sintra, Portugal, offers a distinctive approach to psychedelic therapy, emphasizing the Bwiti tradition in treating conditions like substance use disorder, depression, anxiety, PTSD, and Parkinson’s disease. Their method contrasts with the more common Western medical model, integrating spiritual and cultural elements into treatment. The clinic ensures patient safety through medical screenings and provides ethically-sourced iboga. Root Healing’s holistic care extends beyond the retreat, including counseling and post-treatment integration calls, aiming for comprehensive healing and support.

Legal Status and Availability of Ibogaine

Despite promising evidence and surging commercial interest, ibogaine remains illegal worldwide, including the US and most of Europe where it is classified as a Schedule I controlled substance with high abuse potential and no medical utility. This designation creates barriers for research and pharmaceutical development.

Some drug policy experts argue that ibogaine’s scheduling is outdated given recent data showing its anti-addictive effects. Advocacy groups like the Multidisciplinary Association for Psychedelic Studies (MAPS) are lobbying regulators to ease restrictions on psychedelics like ibogaine for medical use. However, any changes allowing ibogaine treatments would likely depend on completed Phase 3 trials confirming safety and efficacy.

A few countries have adopted more permissive policies on ibogaine. Mexico, Canada, Brazil, and South Africa allow the medical use of ibogaine in research or medically-supervised treatment programs (for substance use disorders). This has enabled both pharmaceutical trials and underground addiction treatment clinics to operate legally in these regions, although enforcement approaches still vary.

The legal status of ibogaine in these countries aims to balance expanding access for therapeutic use with the need for oversight around safety. However, regulators still view non-medical and recreational use of ibogaine as illegal and dangerous without proper medical screening and supervision. Recent licensing frameworks for psychedelics in Canada and psilocybin reform in the US could prompt other jurisdictions to reconsider restrictions on ibogaine.

In a significant move, the Kentucky Opioid Abatement Advisory Commission has proposed using a portion of opioid settlement funds for medical research to further evaluate the effectiveness of ibogaine in treating opioid addiction. This initiative, backed by a legal settlement with pharmaceutical companies and potentially matched by private investors, represents a new approach to exploring ibogaine’s potential in addiction treatment. This development could position Kentucky as a leader in the United States for ibogaine research and its application in addressing the opioid crisis​​.

Patents Related to Ibogaine

This quick overview of patents related to ibogaine is just a preview of the wealth of information available from our friends at Psychedelic Alpha. Please also see their ibogaine patent tracker which list all known patents.

Despite ibogaine’s illegal Schedule I status in the US and most countries, interest persists in developing this compound into an approved medication for substance use disorders. As such, numerous groups have filed for or obtained patents related to ibogaine over the past few decades.

Ibogaine’s complex patent landscape dates back to the 1980s when Howard Lotsof, who originally discovered ibogaine’s anti-addictive properties, filed for multiple patents via his company NDA International. Lotsof patented ibogaine to treat heroin, cocaine, alcohol, nicotine, and other substance addictions.

Since then, Dr. Deborah Mash has become a leader in ibogaine research, first studying the compound in FDA-approved trials in 1993 before setting up offshore clinical programs. Mash holds dozens of patent applications related to ibogaine’s metabolite noribogaine for treating substance abuse and other indications. Her company DemeRx is actively pursuing noribogaine’s development.

Overall, ibogaine patents cover composition of matter, methods of extraction, production routes, formulations, analogs/derivatives, and therapeutic uses. For example, tabernanthalog is a recently developed non-hallucinogenic ibogaine analog with promising medical potential. Navigating existing ibogaine patents has proven challenging for some companies.

While safety concerns have slowed mainstream acceptance, patent activity reflects ongoing commercial interest in unlocking ibogaine’s clinical utility. Recent US state funding for ibogaine PTSD and addiction research could spur more patent filings if initial trials deliver positive results. As larger trials ensue, intellectual property protection will play a key role in justifying investments for developing this controversial compound.

What if You’re Seeking Ibogaine Treatment?

Disclaimer: The goal of Blossom is to provide objective information to inform readers, not to directly recommend or endorse any specific treatment options. This section on pursuing ibogaine treatment does not constitute medical or clinical advice. Blossom has not vetted any of the ibogaine providers mentioned in this report or evaluated their safety, credentials, or outcomes. Those considering ibogaine are strongly advised to conduct thorough independent research and consult a licensed healthcare professional before undergoing any medical intervention.

TRAVEL TO LEGAL CLINICS ABROAD

If you’re seeking ibogaine treatment, several avenues are available, each with its own set of considerations. Traveling to legal clinics abroad, like those in Mexico, Canada, Costa Rica, or South Africa, is often seen as the most reputable option. These clinics offer medically-supervised treatments, including necessary health screenings and physician monitoring, with aftercare typically involving psychotherapy integration. However, the cost can range from $3,000 to over $10,000, depending on the clinic’s amenities.

PARTICIPATE IN UNDERGROUND CEREMONIES

Alternatively, some individuals in the US opt for underground ceremonies, which operate in legal gray areas. These ceremonies, often framed within a religious context, may lack medical oversight, and safety varies greatly depending on the practitioner’s expertise. While more affordable, they involve risks due to minimal medical supervision and the integrative spiritual elements they incorporate.

OBTAIN IBOGAINE ILLEGALLY

Another risky option is obtaining ibogaine illegally, such as ordering online from unverified sources. This approach carries significant risks, including uncertain product purity and potency, and lacks medical support for potential complications. Furthermore, possession of ibogaine can lead to legal penalties in countries where it is prohibited. This method is not recommended unless one is extremely knowledgeable about quality sourcing, testing, and self-administration.

In any of these contexts, careful consideration around screening, dosing, monitoring for adverse effects, and integration support is crucial. The potential benefits of ibogaine as an addiction treatment must be weighed against the safety concerns. Seeking thorough professional medical advice is strongly recommended when considering ibogaine treatment options.