For those battling addiction, ibogaine treatment has emerged as a promising option. This natural alternative has garnered significant attention for its ability to help people live a life of sobriety. With the increasing popularity of ibogaine treatment for addiction recovery, clinical trials are now underway to assess its safety and effectiveness for various health conditions. Although the treatment does not have FDA approval, researchers’ growing interest in its efficacy may lead to extensive exploration of ibogaine’s treatment potential.
What Are Ibogaine Clinical Trials?
Ibogaine clinical trials are research studies designed to study the safety and efficacy of ibogaine as a treatment for addiction and other conditions. These clinical trials aim to understand the outcomes, side effects, and risks of ibogaine treatment. Researchers closely monitor participants to assess the effectiveness and potential risks of ibogaine use. These studies also focus on establishing dosing guidelines and identifying who may benefit the most from treatment. Some recent studies have explored ibogaine’s potential to treat PTSD, alcoholism, and other conditions.
Why Do Ibogaine Clinical Trials Matter?
Ibogaine clinical trials matter because they provide the scientific foundation needed to determine the risks and benefits of the psychoactive compounds found in ibogaine. Despite not having FDA approval, ibogaine treatment is widely used for treating substance addiction and various other mental health conditions. While some reports suggest ibogaine has the ability to disrupt addictive patterns, alleviate withdrawal symptoms, and reset how the brain functions, clinical trials are required to validate these claims.
Clinical trials help determine medical standards, allowing healthcare providers to make informed decisions regarding ibogaine dosage, screening for treatment, and the potential risks associated with treatment. Such standardization can make ibogaine treatment more effective and safer with minimal risks of side effects. These trials broaden our understanding of ibogaine’s potential. They also pave the way for ibogaine, or synthetic forms of it, to be approved by the FDA. This would greatly expand the accessibility of ibogaine treatment throughout North America.
Phases of Clinical Trials
Clinical trials include a series of phases, each with a distinct purpose. These phases are designed to help researchers systematically evaluate ibogaine treatment’s safety, dosage requirements, and potential side effects with precision. Currently, ibogaine clinical trials involve testing the effects of low doses of ibogaine to minimize safety risks. Here are three phases involved in clinical trials:
Phase I: Tests safety and dosing on a small group of healthy volunteer
Phase I of clinical trials is concerned with dosage safety for the participants. It involves testing the drug for the first time on a small group of healthy volunteers to determine a safe dosage and identify potential side effects. The participants are given a low dose of medication at scheduled intervals. The effects on each participant’s health are carefully monitored by keeping track of the changes they experience while under the medication. Since Phase I clinical trials focus on the medication’s safety, they often involve 10 to 100 volunteers and are not as long as other phases.
Phase II: Explores effectiveness in patients with specific conditions
Phase II of clinical trials aims to study the treatment’s effectiveness in a group of patients with specific conditions. This often involves a larger group of participants, ranging from 100 to 300. Since the primary focus of this phase is to determine the efficacy of the treatment, the trial duration is longer than Phase I and involves extensive data collection. Researchers integrate the dosage guidelines obtained from the Phase I trial and monitor the impact it has on patients’ health conditions. If the outcome shows significant improvement in patients’ health with minimal risk of side effects, the trial is approved for the next phase.
Phase III: Large-scale studies to confirm effectiveness and monitor side effects
Phase III of clinical trials involves large-scale studies to more fully determine the treatment’s effectiveness and side effects. Because it involves studying hundreds or thousands of participants with diverse medical backgrounds and requires extensive testing and analysis, the trial phase is much longer than other phases. This stage also explores the long-term health risks and benefits of the treatment plan. Regulatory agencies like the FDA often depend on Phase III trials to determine whether a treatment is approved for public use.
Purpose of Ibogaine Clinical Trials
Here are some of the major purposes of ibogaine clinical trials:
- Evaluating the safety and efficacy of ibogaine
- Determining standard dosage guidelines for effective treatment
- Understanding the long-term impact of the treatment of various health conditions
- Assessing the psychological effects of ibogaine use
- Investigating ibogaine’s treatment potential for broader medical integration
- Enhancing the accessibility of ibogaine treatment
- Establishing medical approval from regulatory authorities
Ongoing and Completed Ibogaine Clinical Trials
Ibogaine is still gaining recognition as an effective treatment. Here is an overview of some of the notable ongoing and completed clinical trials studying ibogaine treatment:
- Subjective Effectiveness of Ibogaine Treatment for Problematic Opioid Consumption: This study was published by the Journal of Psychedelic Studies in 2017. The objective of the study was to evaluate ibogaine’s subjective effects, particularly on problematic opioid use, and its long-term relationship with psychological functioning. The study conducted on 88 patients showed a significant reduction in withdrawal symptoms and opioid cravings, and thirty percent of participants had not used ibogaine again since their treatment.
- Magnesium-ibogaine therapy in veterans with traumatic brain injuries: This study’s initial findings were published in the 2024 issue of Nature Medicine. The clinical trial aims to highlight ibogaine’s potential to treat traumatic brain injuries in veterans. The study was conducted on 30 male veterans with mild TBIs and assessed the impact of a combination dosage of magnesium and ibogaine in alleviating PTSD, anxiety, and depression associated with TBI. Preliminary data showed that participants demonstrated improvement in functioning, anxiety, and depression after treatment and after another month.
- Lesion reduction and neural structural changes following ibogaine treatments for multiple sclerosis: This case report published in 2025 aims to study the effects of ibogaine treatment on MS patients. It presents case studies carried out on two MS patients who went through the treatment, showcasing the neuroplastic and neurodegenerative potential of ibogaine. Both patients showed changes in cortical and subcortical neuroplasticity after the treatment, boosting adaptive neural remodeling. Patient A demonstrated a significant reduction in lesion volume and ADC values, while Patient B exhibited cortical thinning in the motor region that promoted enhanced motor coordination.
- Phase II clinical trial with ibogaine for opioid dependency: This is the first-ever Phase II clinical trial performed on ibogaine’s effectiveness in treating opioid dependency, started by ICEERS. This is an ongoing study conducted in Spain at the Sant Joan de Reus Hospital. Its objective is to test ibogaine treatment protocol with ascending low dosages of ibogaine, helping 20 patients break free from methadone dependence. Through this study, ICEERS aims to contribute to the recognition of ibogaine’s medicinal properties and its ethical sourcing in the West.
- Efficient and modular synthesis of ibogaine and related alkaloids: This report, published in the 2025 issue of Nature Chemistry journal, highlights the anti-addictive properties of the psychoactive alkaloid ibogaine and its active metabolite noribogaine. The study explores the long-lasting therapeutic effects of ibogaine across various substance use disorders and co-occurring neuropsychiatric conditions, like post-traumatic stress disorder and depression.
- Observational study of the long-term efficacy of ibogaine-assisted therapy: This observational study, conducted by MAPS in Mexico, examined the effects of ibogaine treatment in 30 individuals dealing with opioid dependency. The purpose of the study was to collect information on whether ibogaine therapy helped the participants implement positive changes in their substance use patterns and their daily lives. Researchers studied the data collected from a twelve-month follow-up with participants to examine whether ibogaine-assisted therapy helps enhance quality of life and reduce the risks associated with chronic opiate dependency. The results suggest that ibogaine significantly reduced opioid withdrawal symptoms and drug use.
The Future of Ibogaine Clinical Trials
The future of ibogaine clinical trials looks promising due to growing interest in the medical community. Ongoing studies and initial phase clinical trials address the safety risks and explore the broader application of ibogaine for various health conditions, including opioid addiction and TBIs. Because the existing research and trials testing ibogaine’s efficacy are not sufficient, the treatment has not yet achieved FDA approval. However, the continued efforts to publish research on ibogaine treatment may pave the way for medical approval in the future.
Frequently Asked Questions (FAQs)
Some studies suggest that ibogaine may be associated with a number of health risks. One of the most common ibogaine side effects includes cardiovascular complications. Evidence from some case reports also suggests that due to its powerful psychoactive effects, it can cause risks of seizures, mania, and perception disorder. Severe health risks may include serious medical complications and death associated with ibogaine’s neurotoxic and cardiotoxic effects.
Ibogaine is extensively used in treating substance use disorders and associated symptoms. However, recent research is expanding beyond addiction treatment and unlocking the potential of the treatment for a number of health conditions. Recent research conducted by Stanford Medicine researchers explored the effectiveness of ibogaine in alleviating traumatic brain injury symptoms in veterans. It also focused on ibogaine’s positive effects on stress, anxiety, and depression.
No, ibogaine clinical trials are not approved by major regulatory authorities like the FDA due to safety concerns. However, some studies have been conducted that explore the potential benefits and risks of the treatment.
The duration of ibogaine clinical trials depends on the phase and aim of the study. A study may last for a few months or several years, based on whether the study focuses on short-term or long-term outcomes.
To know whether an ibogaine trial is safe and reliable, check the credibility of the body that published the trial. Look for trials conducted by reputed institutions and ensure that the studies follow standard research guidelines.
