Tennessee legislation · 114th General Assembly
Tennessee HB2075: AN ACT to amend Tennessee Code Annotated, Title 9; Title 33; Title 53; Title 63 and Title 68, relative to clinical trials.
Status: Chaptered, May 27, 2026
Fiscal Summary OTHER FISCAL IMPACT To the extent that the federal Food and Drug Administration approves ibogaine for treatment of medical conditions there could be future increases in state expenditures and revenue associated with cohorts researching the use of ibogaine to treat opioid use disorder and other mental health conditions. Such increases are dependent on a number of unknown factors and cannot be reasonably estimated. Bill Summary This bill authorizes a cohort established and selected by the department of mental health and substance abuse services ("department") to conduct drug development clinical trials with ibogaine for the purpose of obtaining approval from the United States food and drug administration ("FDA") for ibogaine as a medication to treat opioid use disorder, co-occurring substance use disorder, and other neurological or mental health conditions for which ibogaine demonstrates efficacy. A cohort must include one or more drug developers, one or more research institutions, which may be an institution of higher education, and one or more hospitals. This bill requires a cohort to select a project lead from among the cohort's members to represent the cohort and perform administrative functions, including contracting with and reporting to the department. A project lead selected by the department is authorized to employ clinical, administrative, and data management personnel necessary to support cohort activities, which may include participation in the Texas consortium for clinical trial collaboration. The cohort project lead must submit a proposal and request for funding to the department. The proposal must provide: The identity of all cohort members. A detailed strategy for obtaining FDA approval for drug development clinical trials. A clinical trial design including team composition, pa
What the bill says
From the amended text:
House Finance, Ways, and Means 1 Amendment No. 3 to HB2075 Hicks G Signature of Sponsor AMEND S e n ate Bill No. 2149 House Bill No. 2075* by deleting all language after the caption and substituting: SECTION 1. Tennessee Code Annotated, Title 53, is amended by adding the following as a new chapter: 53-16-101. Short title. This chapter is known and may be cited as the "HOPE Treatment Act." 53-16-102. Legislative intent. It is the intent of the general assembly to encourage Tennessee-based research institutions to participate in federally authorized ibogaine clinical trials and multistate research collaborations addressing opioid use disorder, post-traumatic stress disorder, traumatic brain injury, and other serious conditions. 53-16-103. Chapter definitions. As used in this chapter: (1) "Healthcare provider" means an individual who is licensed, registered, certified, authorized, or permitted by the laws of this state to administer health care in the ordinary course of business or practice of a profession; (2) "Ibogaine" means ibogaine and ibogaine-based therapeutics, including analogs; (3) "Researcher" means an individual who conducts research or research-related activities as part of a federally authorized clinical trial; and HA1253 (4) "Research institution" means a hospital, academic medical center, or institution of higher education with clinical research capacity located in this state. 53-16-104. Authorization for research participation. (a) Notwithstanding another law to the contrary, a …