A version of the following public comment was submitted to the Texas Senate Committee on Health and Human Services on April 23, 2025.
We believe that studying ibogaine would be beneficial for mental health and addiction care. If ibogaine demonstrates both safety and efficacy, it could facilitate treatment access to millions of Americans suffering from opioid use disorder (OUD) and other mental health conditions. We believe that Senate Bill 2308 provides a sensible regulatory pathway for the advancement of ibogaine as a potential treatment for OUD, co-occurring substance use disorders (SUD), and other relevant neurological or mental health conditions.
Texas can lead the nation in innovative mental health and addiction care solutions with this bill. Senate Bill 2308 prioritizes patient safety and scientific rigor. There are strict requirements for all applicants wishing to conduct trials. To be eligible for the grant, applicants must be private corporation entities with enough capacity and financial resources to conduct FDA trials, seek FDA approval, and conduct future trials. Applicants must also provide detailed plans on trial design, participant recruitment, safety protocols, post-treatment aftercare, and strategy for FDA-approval.
Senate Bill 2308 does not attempt to legalize ibogaine or ibogaine treatment, nor does it try to bypass existing federal regulations. It would retain current prohibitions on possession, use, manufacture, and sale of psychedelic compounds, as well as provide a framework consistent with the FDA drug-approval process, as ibogaine treatment administration will only apply if FDA approval is granted, requiring licensed physicians to supervise its administration in healthcare facilities.
Over the past decade, the medical community has increasingly recognized the potential of psychedelic therapies for the treatment of mental health conditions and addiction. However, despite promising research, access to innovative psychedelic therapies is limited by the FDA’s designation of psychedelics as Schedule I substances. Ibogaine appears to have a unique ability to rapidly reduce withdrawal and craving symptoms associated with opioid addiction, often after just a single dose.
The grant program under SB 3208 offers an opportunity to collect comprehensive safety and efficacy data on ibogaine for treating OUD, SUD, and other mental health disorders, while ensuring alignment with existing federal regulations and FDA drug approval standards.
While not necessarily a major point of concern, we’d like to note that Senate Bill 3208 contains slightly different language regarding funding sources than its companion bill, House Bill 3717. The House Bill allows for funding from both appropriated money and gifts, grants, or donations, while the Senate Bill only allows for funding from gifts, grants, or donations. The House language may provide additional flexibility for the funding of ibogaine studies, potentially allowing for the use of resources such as opioid settlement funds. This broader funding approach could enhance the program’s impact and success.
Overall, SB 3208 would allow Texas to administer grants to conduct potentially life-saving research into ibogaine, which has shown tremendous promise in the therapeutic treatment of OUD, with minimal risk to both public safety and public health. Thank you for your time and consideration.