VA Medicinal Cannabis Research Act of 2019

II 116TH CONGRESS 1ST SESSION S. 179 To direct the Secretary of Veterans Affairs to carry out a clinical trial of the effects of cannabis on certain health outcomes of adults with chronic pain and post-traumatic stress disorder, and for other purposes. IN THE SENATE OF THE UNITED STATES JANUARY 17, 2019 Mr. TESTER (for himself and Mr. SULLIVAN) introduced the following bill; which was read twice and referred to the Committee on Veterans’ Affairs A BILL To direct the Secretary of Veterans Affairs to carry out a clinical trial of the effects of cannabis on certain health outcomes of adults with chronic pain and post-traumatic stress disorder, and for other purposes. Be it enacted by the Senate and House of Representa- 1 tives of the United States of America in Congress assembled, 2 SECTION 1. SHORT TITLE. 3 This Act may be cited as the ‘‘VA Medicinal Cannabis 4 Research Act of 2019’’. 5 VerDate Sep 11 2014 00:01 Jan 26, 2019 Jkt 089200 PO 00000 Frm 00001 Fmt 6652 Sfmt 6201 E:\BILLS\S179.IS S179 pamtmann on DSKBFK8HB2PROD with BILLS 2 •S 179 IS SEC. 2. DEPARTMENT OF VETERANS AFFAIRS CLINICAL 1 TRIAL OF THE EFFECTS OF CANNABIS ON 2 CERTAIN HEALTH OUTCOMES OF ADULTS 3 WITH CHRONIC PAIN AND POST-TRAUMATIC 4 STRESS DISORDER. 5 (a) CLINICAL TRIAL REQUIRED.— 6 (1) IN GENERAL.—The Secretary of Veterans 7 Affairs shall carry out a double-blind randomized 8 controlled clinical trial of the effects of medical- 9 grade cannabis on the health outcomes of covered 10 veterans diagnosed with chronic pain and covered 11 veterans diagnosed with post-traumatic stress dis- 12 order. 13 (2) REQUIRED ELEMENTS.—The clinical trial 14 required by paragraph (1) shall include— 15 (A) with respect to covered veterans diag- 16 nosed with chronic pain, an evaluation of the 17 effects of the use of cannabis on— 18 (i) neuropathic pain (including pain 19 intensity and pain-related outcomes); 20 (ii) the reduction or increase in opioid 21 use or dosage; 22 (iii) the reduction or increase in 23 benzodiazepine use or dosage; 24 (iv) the reduction or increase in alco- 25 hol use; 26 VerDate Sep 11 2014 00:01 Jan 26, 2019 Jkt 089200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S179.IS S179 pamtmann on DSKBFK8HB2PROD with BILLS 3 •S 179 IS (v) inflammation; 1 (vi) sleep quality; 2 (vii) spasticity; 3 (viii) agitation; and 4 (ix) quality of life; and 5 (B) with respect to covered veterans diag- 6 nosed with post-traumatic stress disorder 7 (PTSD), an evaluation of the effects of the use 8 of cannabis on— 9 (i) the symptoms of PTSD (based on 10 the Clinician Administered PTSD Scale, 11 the PTSD checklist, the PTSD symptom 12 scale, the posttraumatic diagnostic scale, 13 and other applicable methods of evaluating 14 PTSD symptoms); 15 (ii) the reduction or increase in 16 benzodiazepine use or dosage; 17 (iii) the reduction or increase in alco- 18 hol use; 19 (iv) mood; 20 (v) anxiety; 21 (vi) social functioning; 22 (vii) agitation; 23 (viii) suicidal ideation; and 24 VerDate Sep 11 2014 00:01 Jan 26, 2019 Jkt 089200 PO 00000 Frm 00003 Fmt 6652 Sfmt 6201 E:\BILLS\S179.IS S179 pamtmann on DSKBFK8HB2PROD with BILLS 4 •S 179 IS (ix) sleep quality, including frequency 1 of nightmares and night terrors. 2 (3) OPTIONAL ELEMENTS.—The clinical trial 3 required by paragraph (1) may include an evaluation 4 of the effects of the use of cannabis to treat chronic 5 pain and PTSD on— 6 (A) pulmonary function; 7 (B) cardiovascular events; 8 (C) head, neck, and oral cancer; 9 (D) testicular cancer; 10 (E) ovarian cancer; 11 (F) transitional cell cancer; 12 (G) motor vehicle accidents; 13 (H) mania; 14 (I) psychosis; 15 (J) cognitive effects; or 16 (K) cannabinoid hyperemesis syndrome. 17 (b) COVERED VETERANS.—In this section, the term 18 ‘‘covered veteran’’ means a veteran who is enrolled in the 19 patient enrollment system of the Department of Veterans 20 Affairs under section 1705 of title 38, United States Code. 21 (c) LONG-TERM OBSERVATIONAL STUDY.—The Sec- 22 retary may carry out a long-term observational study of 23 the participants in the clinical trial required under sub- 24 section (a). 25 VerDate Sep 11 2014 00:01 Jan 26, 2019 Jkt 089200 PO 00000 Frm 00004 Fmt 6652 Sfmt 6201 E:\BILLS\S179.IS S179 pamtmann on DSKBFK8HB2PROD with BILLS 5 •S 179 IS (d) TYPE OF CANNABIS.—In carrying out the clinical 1 trial required by subsection (a), the Secretary shall 2 study— 3 (1) varying forms of cannabis, including— 4 (A) full plants and extracts; and 5 (B) at least three different strains of can- 6 nabis with significant variants in phenotypic 7 traits and various ratios of tetrahydrocannabi- 8 nol and cannabidiol in chemical composition; 9 and 10 (2) varying methods of cannabis delivery, in- 11 cluding combustible and non-combustible inhalation 12 and ingestion. 13 (e) USE OF CONTROL AND EXPERIMENTAL 14 GROUPS.—The clinical trial required by subsection (a) 15 shall include both a control group and an experimental 16 group which shall— 17 (1) be of similar size and structure; and 18 (2) represent the demographics of the veteran 19 population, as determined by the most recent data 20 from the American Community Survey that is avail- 21 able prior to the commencement of the clinical trial. 22 (f) DATA PRESERVATION.—The clinical trial required 23 by subsection (a) shall include a mechanism to ensure the 24 preservation of all data, including all data sets, collected 25 VerDate Sep 11 2014 00:01 Jan 26, 2019 Jkt 089200 PO 00000 Frm 00005 Fmt 6652 Sfmt 6201 E:\BILLS\S179.IS S179 pamtmann on DSKBFK8HB2PROD with BILLS 6 •S 179 IS or used for purposes of the research required by sub- 1 section (a) in a manner that will facilitate further re- 2 search. 3 (g) IMPLEMENTATION.—Not later than 180 days 4 after the date of the enactment of this Act, the Secretary 5 shall— 6 (1) develop a plan to implement this section 7 and submit such plan to the Committees on Vet- 8 erans’ Affairs of the House of Representatives and 9 the Senate; and 10 (2) issue any requests for proposals the Sec- 11 retary determines appropriate for such implementa- 12 tion. 13 (h) EFFECT ON OTHER BENEFITS.—The eligibility 14 or entitlement of a covered veteran to any other benefit 15 under the laws administered by the Secretary or any other 16 provision of law shall not be affected by the participation 17 of the covered veteran in a clinical trial or study under 18 this section. 19 (i) REPORTS.—During the five-year period beginning 20 on the date of the enactment of this Act, the Secretary 21 shall submit periodically, but not less frequently than an- 22 nually, to the Committees on Veterans’ Affairs of the 23 VerDate Sep 11 2014 00:01 Jan 26, 2019 Jkt 089200 PO 00000 Frm 00006 Fmt 6652 Sfmt 6201 E:\BILLS\S179.IS S179 pamtmann on DSKBFK8HB2PROD with BILLS 7 •S 179 IS House of Representatives and the Senate reports on the 1 implementation of this section. 2 Æ VerDate Sep 11 2014 00:01 Jan 26, 2019 Jkt 089200 PO 00000 Frm 00007 Fmt 6652 Sfmt 6301 E:\BILLS\S179.IS S179 pamtmann on DSKBFK8HB2PROD with BILLS