(1) As used in this section: (a) "Clinical study" means the safety and feasibility study authorized in this section. (b) "Controlled substance" means the same as that term is defined in Section 58-37-2. (c) "Eligible veteran" means a veteran who has treatment-resistant PTSD. (d) "FDA" means the United States Food and Drug Administration. (e) "Huntsman Mental Health Institute" means the mental health and substance use treatment institute within the University of Utah. (f) "Investigational drug" means an investigational new drug that the FDA has authorized for human subjects research under 21 C.F.R. Part 312. (g) "Investigational new drug" means the same as that term is defined in 21 C.F.R. Sec. 312.3. (h) "Psychedelic drug" means a controlled substance that is an investigational drug and has a hallucinogenic effect on the central nervous system, including: (i) 3,4-Methylenedioxymethamphetamine (MDMA); (ii) 5-methoxy-N,N-dimethyltryptamine; or (iii) Psilocybin. (i) "Psychedelic-assisted therapy" means an intervention where: (i) a psychedelic drug is administered to an individual with treatment-resistant PTSD in a controlled clinical setting; and (ii) a qualified therapist delivers manualized, trauma-informed preparatory and integrative psychotherapy to the individual before and after administration of the psychedelic drug. (j) "PTSD" means post-traumatic stress disorder. (k) "Treatment-resistant PTSD" means a clinical diagnosis of PTSD with documented inadequate response to one or more evidence-based treatments for PTSD. (2) Subject to Subsections (4) and (5), within appropriations from the Legislature for this purpose and any gifts, grants, or donations the Huntsman Mental Health Institute receives under Subsection (3), the Huntsman Mental Health Institute shall conduct a clinical study to research the safety and feasibility of psychedelic-assisted therapy for the treatment of treatment-resistant PTSD in eligible veterans. (3) The Huntsman Mental Health Institute may accept gifts, grants, and donations of money to fund the clinical study. (4) (a) The Huntsman Mental Health Institute shall begin the clinical study no later than January 1, 2027, if the total amount of legislative appropriations and gifts, grants, or donations the Huntsman Mental Health Institute receives under Subsection (3) reaches an amount that is equal to or exceeds an amount the Huntsman Mental Health Institute determines is sufficient to begin the clinical study. (b) If the Huntsman Mental Health Institute begins the clinical study on or before January 1, 2027, the Huntsman Mental Health Institute may: (i) accept gifts, grants, or donations after January 1, 2027; and (ii) use amounts received under Subsection (3), or appropriated by the Legislature for this purpose, after January 1, 2027, to continue funding the clinical study. (5) If the Huntsman Mental Health Institute does not begin the study on or before January 1, 2027, because the total amounts accepted and appropriated under this section are insufficient to begin the clinical study, the Huntsman Mental Health Institute: (a) may continue to accept gifts, grants, or donations, after January 1, 2027; (b) shall begin the clinical study when the total amount of legislative appropriations and gifts, grants, or donations reaches an amount that is equal to or exceeds an amount the Huntsman Mental Health Institute determines is sufficient to begin the clinical study; and (c) may use amounts received under Subsection (3), or appropriated by the Legislature for this purpose, after January 1, 2027, to continue funding the clinical study. (6) The Huntsman Mental Health Institute shall return to a donor any unused gifts, grants, or donations the Huntsman Mental Health Institute received under Subsection (3) on or before July 1, 2032. (7) Before beginning the clinical study, the Huntsman Mental Health Institute shall: (a) comply with state and federal regulations, including by: (i) ensuring that the clinical study will be conducted under an FDA investigational new drug application; (ii) maintaining a United States Drug Enforcement Agency Schedule I research registration and any required state controlled substance registration; and (iii) obtaining Institutional Review Board approval for the clinical study; (b) have a clinical study protocol that includes: (i) the study design, inclusion and exclusion criteria, objectives and endpoints, eligible veteran visit schedule, and schedule of follow-up assessments; (ii) informed consent procedures and participant safeguards; and (iii) data security and privacy protections, including for personal information; (c) have a drug administration plan for the clinical study that includes: (i) the investigational drug product description, source, formulation, route of administration, and dosing regimen; (ii) a clinical staffing model and monitoring procedures for the administration of the investigational drug; (iii) discharge criteria and transportation procedures for participants after psychedelic-assisted therapy; and (iv) procedures for the storage, handling, chain of custody, and disposal of controlled substances, and an accountability plan for violations of the procedures; (d) have a safety monitoring and risk management plan for the clinical study that includes: (i) medical and psychiatric screening procedures; (ii) on-site emergency response procedures; (iii) adverse event and serious adverse event capture and reporting timelines; and (iv) predefined rules for pausing or stopping the clinical study; and (e) have a fidelity plan for the clinical study that includes: (i) a psychotherapy manual that describes preparatory sessions, therapeutic support boundaries for the administration of the investigational drug during psychedelic-assisted therapy sessions, and integrative sessions; (ii) therapist licensure and qualification requirements; (iii) a training, supervision, and fidelity monitoring plan; and (iv) ethical safeguards and a participant complaint and grievance process. (8) (a) The Huntsman Mental Health Institute shall: (i) report to the Health and Human Services Interim Committee, upon request of the committee, on the progress of the clinical study; and (ii) submit a final written report of the clinical study to the Health and Human Services Interim Committee on or before the committee's first November meeting after the date on which the Huntsman Mental Health Institute concludes the clinical study. (b) The report described in Subsection (8)(a)(ii) shall include: (i) safety and feasibility outcomes for the use of psychedelic-assisted therapy for the treatment of treatment-resistant PTSD in eligible veterans; and (ii) secondary or exploratory clinical outcomes of the clinical study.
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