Department of Veterans Affairs clinical trials on the effects of cannabis on certain health outcomes of veterans with chronic pain and post-traumatic stress disorder

(a) Clinical trials required (1) In general If the Secretary indicates in the report required by section 2(d) that the Secretary is able to meet the criteria necessary to proceed to clinical trials, commencing not later than 180 days after the submittal of that report, the Secretary shall carry out a series of clinical trials on the effects of cannabis appropriate for investigational use, as determined by the Food and Drug Administration under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)), on the health outcomes of covered veterans diagnosed with chronic pain and covered veterans diagnosed with post-traumatic stress disorder. (2) Considerations The clinical trials required by paragraph (1) shall include, as appropriate, an evaluation of key symptoms, clinical outcomes, and conditions associated with chronic pain and post-traumatic stress disorder, which may include— (A) with respect to covered veterans diagnosed with chronic pain, an evaluation of the effects of the use of cannabis on— (i) osteopathic pain (including pain intensity and pain-related outcomes); (ii) the reduction or increase in opioid use or dosage; (iii) the reduction or increase in benzodiazepine use or dosage; (iv) the reduction or increase in alcohol use; (v) the reduction or increase in the prevalence of substance use disorders; (vi) inflammation; (vii) sleep quality; (viii) agitation; (ix) quality of life; (x) exacerbated or new mental health conditions; and (xi) suicidal ideation; and (B) with respect to covered veterans diagnosed with post-traumatic stress disorder, an evaluation of the effects of the use of cannabis on— (i) the symptoms of post-traumatic stress disorder (PTSD) as established by or derived from the clinician administered PTSD scale, the PTSD checklist, the PTSD symptom scale, the post-traumatic diagnostic scale, and other applicable methods of evaluating symptoms of post-traumatic stress disorder; (ii) the reduction or increase in benzodiazepine use or dosage; (iii) the reduction or increase in alcohol use; (iv) the reduction or increase in the prevalence of substance use disorders; (v) mood; (vi) anxiety; (vii) social functioning; (viii) agitation; (ix) suicidal ideation; and (x) sleep quality, including frequency of nightmares and night terrors. (3) Optional elements The clinical trials required by paragraph (1) may include, as appropriate, an evaluation of the effects of the use of cannabis to treat chronic pain and post-traumatic stress disorder on other symptoms, clinical outcomes, and conditions not covered by paragraph (2), which may include— (A) pulmonary function; (B) cardiovascular events; (C) head, neck, and oral cancer; (D) testicular cancer; (E) ovarian cancer; (F) transitional cell cancer; (G) intestinal inflammation; (H) motor vehicle accidents; or (I) spasticity. (b) Long-Term observational study The Secretary may carry out a long-term observational study of the participants in the clinical trials required by subsection (a). (c) Type of cannabis (1) In general In carrying out the clinical trials required by subsection (a), the Secretary shall study varying forms of cannabis, including whole plant raw material and extracts, and may study varying routes of administration. (2) Plant cultivars Of the varying forms of cannabis required under paragraph (1), the Secretary shall study plant cultivars with varying ratios of tetrahydrocannabinol to cannabidiol. (d) Implementation Not later than 18 months after the date of the enactment of this Act, the Secretary shall— (1) develop a plan to implement this section and submit such plan to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives; and (2) issue any requests for proposals the Secretary determines appropriate for such implementation. (e) Termination of clinical trials (1) Clinical guideline requirements or excessive risk The Secretary may terminate the clinical trials required by subsection (a) if the Secretary determines that the Department of Veterans Affairs is unable to meet clinical guideline requirements necessary to conduct such trials or the clinical trials would create excessive risk to participants. (2) Completion upon submittal of final report The Secretary may terminate the clinical trials required by subsection (a) upon submittal of the final report required under subsection (f)(2). (f) Reports (1) Periodic reports During the five-year period beginning on the date of the commencement of clinical trials required by subsection (a), the Secretary shall submit periodically, but not less frequently than annually, to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives reports on the implementation of this section. (2) Final report Not later than one year after the completion of the five-year period specified in paragraph (1), the Secretary shall submit to the Committee on Veterans’ Affairs of the Senate and the Committee on Veterans’ Affairs of the House of Representatives a final report on the implementation of this section.