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Ibogaine FDA Clinical Trial

Ibogaine Clinical Trial

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KRFI supports the research and development of evidence-based medical research to develop informed policies.

KRFI committed to advancing clinical research for diverse natural products derived mental health entheogens.

KRFI is committed to FDA IND Clinical Trial Development for Opioid Use Disorder and Substance Use Disorder. 

 

To support the collective knowledge on the topics, our Contract Research Organization Team is prepared to launchhe the OUD/SUD in FDA Investigative New Drug Application

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Ibogaine Clinical Trial for Opioid Use Disorder/Substance Use Disorder

 

Leveling Up Ibogaine Schedule 1 Controlled Substance Procurement for Clinical Trial Batch Supply Chain Initiatives to Ensure Accountability, Sustainability, and Optimization in IP Management

 

KRFI CRO for IBOGAINE OUD/SUD US FDA Clinical Trial Protocol (Call for RFP for Clinical Trial Partnership)

 

Clinical Trial on Ibogaine for OUD/SUD indication for FDA IND CT Development is underway

Recruiting

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Ibogaine has demonstrated promise for substance use disorders (SUDs), psychotherapy, and personal growth. But there is a difference between what anecdotal reports have shared and what can be replicated in a clinical environment. In addition, many ibogaine treatments are conducted as a Mahattan Project and grew as an “underground” and may not follow rigorous protocols to ensure the safety of the participant or collect valid results for later analysis.3 This study arose to fill this important gap to expand the collective knowledge base on the potential of ibogaine as a treatment option, in hope that it inspires the scientific community and supports sensible changes in policy.

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The KRFI FDA clinical trial came after years of the ibogaine medical subculture from New York City as Mahattan Project, and the lessons learned from its experience of Howard Lotsof and Bob Sisko Rand, Dr. Joseph Gross's development of the clinical trial in Panama and global partnership and alliance had rooted in 1996-2015 through the Global Ibogaine Therapist Alliance born from NYC..  Our FDA Clinical studies aims to integrates ibogaine for OUD/SUD therapeutics with Tramatic Brain Injuries, and Parkinson's disease applications for the veterans and the tribal opioid/substance response facilitation and harm reduction.   The health equity for the access for ibogaine assures global social equity and human rights for the treatments. 

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The main objective of the FDA clinical trial is to evaluate the efficacy and safety of ibogaine for the treatment through the rigorous evaluation of today's poly-synthetic drug potential withdrawal. KRFI Clinical Research aims to assess the adverse reaction of the poly-synthetic drug impact of the participants’ satisfaction with the treatment with profile of ibogaine for anti-addiction therapeutics. We seek partnership to design safe, effective outpatient treatments for opioid / substance withdrawal. The collection of qualitative data is essential to interpret the efficacy of ibogaine treatment.

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The clinical trial is linked with a consortium and PPP strategic stakeholders approach for consortiumized  for the global Ibogaine Global Clinical Trial Allicance where the Private Public Sector Partners engaged clinical alliance with stakeholders in Gabon and Ibogaine producing partners internationally to envision a future for the sustainable and safe medicines of the mission to discover, develop, deliver. 

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The clinical trial selection for participants criteria will be recruited from the Medically Assisted Therapy Maintenance Program at the Hospital in Texas, NYS in an multi-centered national consortium. The hospital engaged in the studies are a pioneering in patient center for harm reduction.  The state level and national alliance with a University Hospital helps to ongoing research working group on a Questors open source Ibogaine and psychedelics Clincal Trial Platform with state level response to harm reduction plans to create a specialized team with safe experience in the treatment of OUDs/SUDs.

 

KRFI aims to establish a multi-disciplinary collaboration in the protocol design for the participants of ibogaine clinical studies . 

 

The study is continuing to recruit participants, further details are below.

 

Sustainably sourced ibogaine by Private Public Sector Partnership of the country in the equatorial region globally.

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Ibogaine is a potent anti-addiction treatment for SUDs, There are naturally derived and standardized botanical drug formulation of many compounds found within iboga (Tabernanthe iboga and Voacanga iboga). T. iboga is known as “sacred root” by the bwitie people of Gabon and indigneous people of West Africa.  Currently the iboga plant is being illegally trafficked and remains on the Interpol and UNCED's no. 1 list of Access for Benefit Sharing.  KRFI seeks your partnership for the Access for Benefit Sharing -IP (ABS-IP) partnership in States, and in global partnership for sustainable agriculture, GAP, GSP, GMP, GCP protocol with WHO prequalification for the GAP, GSP, GMP processing partners.    Conservation of the indigenous sources are now imperative as it is experiencing a rapid decline in the wild due to drug trafficking.  We encourage your to be our partner to support the loss of the wild cultivars due to the to the rising interest and demand for iboga and ibogaine leading to over-harvesting and illegal poaching. The majority of the ibogaine used by treatment providers comes from iboga can be sustainabily grown through the participating Private Public Sector partnership within the UNCED frame work and all products grown and extracted from Voacanga africana, and other regional cultivars of the African iboga tree has been identified and selected for a more sustainable production options.

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Join us in the pursuit of a sustainable entheogic science of traditional plant medicines via a sustainable agriculture, and scientific protocol is required for the mental health securiy of nations seeking treatment from iboga plants.   Become part of our drug supply chain security hyerledger of knowledge and information systems from continuing. PPP in the Ministry of Agriculture, Forestry, Health of PPP structures supervised sustainability with biodiversity and carbon credits for the KRFI for agricultural sources concerns addressed by sourcing ibogaine from cultivated iboga (the Nagoya Protocol), from V. africana, and efficient and effective formulation technologies. The ibogaine for the KRFI clinical trial is sourced from Voacanga africana cultivar.

 

Mental Health Psychedelic Clinical Trials partnership products include entheogens such as:

5 Meo DMT

Mescaline

Psylicybin

DMT

Ayahuasca

 

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Support our Research & Innovation

Ibogaine has demonstrated promise for Opioid and Substance use disorders (SUDs), psychotherapy, and personal growth. But there is a difference between what anecdotal reports have shared and what can be replicated in a clinical environment. In addition, many ibogaine treatments are conducted as a Mahattan Project and grew as an “underground” and may not follow rigorous protocols to ensure the safety of the participant or collect valid results for later analysis.3 This study arose to fill this important gap to expand the collective knowledge base on the potential of ibogaine as a treatment option, in hope that it inspires the scientific community and supports sensible changes in policy.

The current Clinical Trial came after years of engaging with the Manhattan Project as ibogaine medical subculture and the lessons learned from its experience. Our study is more than a clinical trial. It is the creation of a model that integrates ibogaine, state-of-the-art harm reduction, and OUD/SUD therapy that can inspire policies adoption.  The aim is to assure access to those who need it and not just those who can afford it. 

 

Howard Lotsof and Bob Sysko’s continued development of the clinical trial in Panama and global partnership and alliance had rooted in 1996-2015.

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The objective of the clinical trial is to evaluate the efficacy and safety of ibogaine for the treatment of Poly Synthetic Drug withdrawal.   Researchers are assessing the side effect profile of ibogaine and participants’ reach safety and efficacious treatment. The Clinical Trial will serve as a ethical design protocol to ensure safe, effective outpatient treatments for opioid substance withdrawal and effective recovery.  The FDA clinical trial aims to bring qualitative data essential for the efficacy of ibogaine treatment.

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The clinical trial is linked with a larger strategic approach consolidated through our Iboga and Ibogaine global Initiative, where we engaged with stakeholders in Gabon and tropical countries' indigenous cultivars for sustainable agricultural production to support the local private public sector governement leadership to international utilization to envision a future for the Iboaine as an effective medicines. 

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The clinical trial to call for participants recruitment with the CASA Columbia and NYC hospital in an pioneering partnership for harm reduction. The alliance with University Hospital helps to open the possibility of ongoing research possibilities. Working in the consortium and multi-center in-patient hospital allow us to create a highly specialized team with experience in the treatment of OUD/SUDs, TBI, and PTSD.  In addition, the Addiction medicine psychiatrists,  multi-deciplianry team of neurologists, cardiologists collaborat in the protocol design and are during the ibogaine clinical trial sessions. The study is recruit participants, further details are below.

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The human tragedy reaches its climax in the fact that after all the exertions and sacrifices of hundreds of millions of people and of the victories of the righteous cause, we still have not found Peace or Security, and that we lie in the grip of even worse perils than those we have surmounted. - Winston Churchill 

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Nations that has conscripted for policies of guns and drugs as personal protection weaponizes its own youths. Many have suffered just as many defeats, in the wars against drugs and gun violence had been fought before adopting preventive policies before addressing the war is surmountable as a precise step. 
-MyungHi Sonserai Lee

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