OBJECTIVE

The Texas Ibogaine Initiative seeks the allocation of $50,000,000 in state funds to establish a public private partnership through which a co-equal $50,000,000 matching contribution from a drug developer will fund Texas-based FDA-approved clinical trials with ibogaine as a breakthrough therapeutic for opioid use disorder, co-occurring substance use disorder, and any co-occurring mental health conditions for which it demonstrates efficacy. Texas' commitment to this project will be joined by the philanthropic support of three prominent family foundations which are committed to advancing ibogaine's development as an FDA-approved medication.

RATIONALE

Opioid withdrawal syndrome is the profound neurochemical brain injury which drives the compulsive dynamic of repeated relapse, overdose, and death among those struggling to achieve sustained recovery. Opioid exposure terminates the brain's organic ability to produce the body's baseline survival chemicals – dopamine and serotonin. Decades of open label clinical studies have produced an abundance of observational data which suggest that a psychoactive alkaloid called ibogaine resolves opioid withdrawal syndrome within 48 to 72 hours when properly administered in a clinically controlled medical setting. It has the singular unique ability to clear and reset the brain's opioid receptors while also restoring the brain's organic dopamine and serotonin production to pre-opioid exposure levels – a process which doesn't otherwise begin to occur until a person has been completely abstinent for 18 months. Ibogaine's effects extend to individuals suffering from methamphetamine, cocaine, and alcohol dependency. Ibogaine fully resolves physiological substance dependence within 80% of individuals with a single treatment and 97% of individuals with a second supportive dose. On January 5, 2024, the internationally esteemed medical research journal “Nature Medicine” published the phenomenal results of a groundbreaking study of a cohort of U.S. Special Forces veterans who traveled to Mexico to receive ibogaine treatment for traumatic brain injuries and post-traumatic stress disorder. A single treatment fully resolved all their symptomatology which also included treatment resistant depression and anxiety. Diagnostic imaging studies confirmed that ibogaine has broad-based regenerative effects on the human brain which include the global restoration of white matter, the enlargement of brain structures responsible for emotional regulation and executive functioning, and a reversal of physiologic brain age. In the words of the study's chief investigator, Dr. Nolan Williams, the data demonstrate that “Ibogaine is the most sophisticated drug on the planet.” Ibogaine is a legal medication in Mexico, Brazil, New Zealand and South Africa.

CONCLUSION

Texas can become the epicenter of developmental gravity for all of ibogaine's advanced therapeutic applications by committing $50,000,000 in state funds to create a public private partnership which would develop and execute FDA-approved clinical trials with ibogaine in conjunction with research universities such as the University of Texas, Texas Tech, and Baylor University. Within this model, Texas will preserve its commercialization interests in any patentable intellectual property which will be produced by this endeavor. By doing so, Texas will pioneer the creation of a revolutionary new field of biomedical research and development, bringing curative relief to millions of individuals who lack access to effective treatment for intractable, debilitating conditions.

SUPPORTERS OF IBOGAINE DEVELOPMENT AND RESEARCH

• Texas Veterans of Foreign Wars
• Special Operations Veterans
• Veteran Mental Health Leadership Coalition
• Texas Emerging Therapies Association
• Texans for Greater Mental Health
• Medal of Honor Recipient Dakota Meyer
• Congressman Morgan Luttrell, Retired US Navy Seal
• Congressman Dan Crenshaw, Retired US Navy Seal

DATA

Texas and the Opioid Epidemic

• Approx. 1 million Texans suffer from opioid use disorder.
• Texas suffers approx. 3,000 opioid-related deaths each year.
• The opioid epidemic costs the United States nearly $1.5 trillion annually in healthcare costs, lost productivity, criminal justice interventions, and addiction treatment expenses.

Veteran Mental Health Crisis

• PTSD affects 11-20% of veterans from operations in Iraq and Afghanistan per year.
• 17-44 veterans die by suicide each day with more than 150,000 veterans losing their lives to suicide since 2001.
• Suicide rate for veterans is 1.5x that of the general population.

Efficacy of Existing Treatment Models

Note: SSRI/SNRI treatments are slow-acting, low-efficacy with it taking up to six weeks for medication to take effect.

• OUD treatments including Methadone, Suboxone, and Abstinence: 7% - 26%
• Available treatments do not reverse neurochemical brain injury caused by opioid dependence. Methadone and Buprenorphine are opioids which maintain a patient’s physiological dependency.
• PTSD treatments including SSRIs: 20% - 60% cessation of symptoms with no curative effect.
• Depression treatments including SSRIs and therapy: 40% - 60% cessation of symptoms with moderate to severe side effects from SSRI/SNRI treatments and no curative effect.
• Anxiety treatments including SSRIs and therapy: Up to 60% cessation of symptoms with moderate to severe side effects from SSRI/SNRI treatments and no curative effect.

Efficacy of Ibogaine Therapy

• OUD: 80% effectiveness for individuals with OUD after a single dose // 97% with a second supportive dose.
• PTSD: 100% reduction of symptoms to no disability diagnosis 1-month after treatment.
• Depression: 78% reduction of symptoms to no diagnosis after a 12-month assessment.
• Anxiety: 90% reduction of symptoms after a 12-month assessment.

DEFINITIONS

• Ibogaine is a naturally occurring alkaloid derived from three West African botanical sources. It is a non-classical psychedelic which has demonstrated breakthrough therapeutic efficacy for substance dependence (opioids, methamphetamine, cocaine, alcohol, and tobacco).
• Opioid Use Disorder (OUD) is a medical condition characterized by physiological dependence on opioids, leading to significant impairment or distress. This disorder encompasses the use of substances ranging from legally prescribed medications to illicit drugs like heroin and fentanyl.