UNOFFICIAL COPY 25 RS BR 324
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AN ACT relating to Ibogaine research in the Commonwealth. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
SECTION 1. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO 3
READ AS FOLLOWS: 4
As used in Sections 1 to 4 of this Act: 5
(1) "Department" means the Department of Agriculture; and 6
(2) "Private entity" means an incorporated business licensed to operate in the 7
Commonwealth. 8
SECTION 2. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO 9
READ AS FOLLOWS: 10
It is the declared policy of the Commonwealth that ibogaine is worthy of clinical 11
research, trials, and studies as a potential viable therapeutic treatment of opioid 12
dependence and any other co-occurring mental health disorders. The purposes of 13
Sections 1 to 4 of this Act are to: 14
(1) Promote the research and study of ibogaine as a treatment of opioid dependence 15
and any other co-occurring mental health disorders; and 16
(2) Promote the creation of an industry in the Commonwealth related to the study of 17
ibogaine. 18
SECTION 3. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO 19
READ AS FOLLOWS: 20
(1) There is hereby established in the State Treasury a trust and agency fund entitled 21
the ibogaine research fund, to be administered by the department for the purpose 22
of allowing private entities that operate in the Commonwealth to partially cover 23
the costs of ibogaine research in the Commonwealth. 24
(2) The fund may receive state appropriations, gifts, grants, federal funds, and any 25
other funds both public and private. Money deposited in the fund is hereby 26
appropriated for purposes set out in Sections 1 to 4 of this Act. 27 UNOFFICIAL COPY 25 RS BR 324
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(3) Notwithstanding KRS 45.229, any unallocated or unencumbered balances in the 1
fund shall be invested as provided in KRS 42.500(9), and any interest or other 2
income earned from the investments, along with the unallotted or unencumbered 3
balances in the fund, shall not lapse but shall be carried forward for into the next 4
fiscal year. 5
SECTION 4. A NEW SECTION OF KRS CHAPTER 218A IS CREATED TO 6
READ AS FOLLOWS: 7
A private entity that applies for a distribution from the fund established in Section 3 of 8
this Act shall: 9
(1) Conduct and fund research in the Commonwealth related to: 10
(a) Ibogaine, including pharmaceutical development and the efficacies of 11
ibogaine for the treatment of opioid dependence and any other co-occurring 12
mental health disorders; 13
(b) The health effects, including the potential risks or side effects, of the use of 14
ibogaine; and 15
(c) The efficacy and potential health effects of various ibogaine delivery 16
methods; 17
(2) Review current and future ibogaine research literature, clinical studies, and 18
clinical trials; 19
(3) Monitor, to the extent that appropriate and sufficient data is available, patient 20
outcomes in states and countries that allow ibogaine research or usage; and 21
(4) Submit an application to the federal Drug Enforcement Administration to: 22
(a) Allow for it to conduct clinical research, trials, and studies of ibogaine as a 23
potential viable therapeutic treatment of opioid dependence and any other 24
co-occurring mental health disorders; 25
(b) Provide a detailed description of the planned strategy for securing an 26
approved "Investigation of New Drug" (IND) application from the Federal 27 UNOFFICIAL COPY 25 RS BR 324
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Drug Administration (FDA). IND approval from the FDA is a prerequisite 1
for clinical research and trials; and 2
(c) Provide a detailed clinical trial design including a description of the 3
composition of the entity's clinical trial team by expertise, clinical trial 4
participant recruitment plan, detailed patient screening criteria, cardiac 5
safety protocols, administration protocols, aftercare, post-acute treatment 6
support plan, and data integrity plan. 7