AN ACT to amend Tennessee Code Annotated, Title 9; Title 33; Title 53; Title 63 and Title 68, relative to clinical trials.
SB2149 creates the “HOPE Treatment Act” and authorizes Tennessee research institutions to participate in federally authorized clinical trials involving ibogaine, including multistate research collaborations. The bill states legislative intent to encourage Tennessee-based institutions to take part in research addressing opioid use disorder, post-traumatic stress disorder, traumatic brain injury, and other serious conditions. It defines key terms such as healthcare provider, researcher, research institution, and ibogaine, and allows institutions to receive federal, private, or philanthropic funding for these trials.
The bill is narrowly framed: it does not legalize ibogaine generally, but permits its administration only within a clinical trial conducted at a hospital or qualified research facility and under the medical direction of a Tennessee-licensed physician. It requires compliance with applicable state and federal law, including FDA investigational new drug authorization when required, and directs participating institutions to use appropriate patient screening and safety protocols. It also provides liability protection from state criminal controlled-substance laws for providers, researchers, patients, and institutions acting within the scope of an authorized trial and federal law.
SB2149 adds a new chapter to Title 53 of the Tennessee Code and creates an express statutory safe harbor for ibogaine clinical research. It limits the reach of state controlled-substance laws, including the Tennessee Drug Control Act, by exempting compliant trial participants from criminal liability solely for conduct occurring as part of an authorized clinical trial. The bill also affects research institutions, hospitals, academic medical centers, higher education institutions, physicians, and researchers by clarifying when ibogaine-related research activity is permitted and by allowing outside funding for such work.
The bill appears to have broad support in the legislature, with unanimous committee recommendations and overwhelming floor approval. The recorded votes show strong bipartisan backing, suggesting the measure was viewed as a controlled research authorization rather than a broader drug-policy change. The absence of committee transcript material limits insight into detailed debate, but the vote pattern indicates generally favorable sentiment toward expanding clinical research options for serious conditions.
The main point of potential contention is the use of ibogaine, a substance associated with controlled-substance concerns, and whether state law should provide explicit protection for its clinical use. Any opposition would likely center on patient safety, regulatory oversight, and the risk of creating a pathway that could be seen as loosening drug restrictions. The bill addresses those concerns by restricting use to federally authorized trials, requiring FDA IND compliance when applicable, and limiting administration to qualified facilities under physician supervision.