II 

118TH CONGRESS 

1ST SESSION S. 326 

To direct the Secretary of Veterans Affairs to carry out a study and clinical 

trials on the effects of cannabis on certain health outcomes of veterans 

with chronic pain and post-traumatic stress disorder, and for other purposes. 

IN THE SENATE OF THE UNITED STATES 

FEBRUARY 9, 2023 

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 study and clinical trials on the effects of cannabis 

on certain health outcomes of veterans with chronic pain 

and post-traumatic stress disorder, and for other purposes. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘VA Medicinal Cannabis 

5 Research Act of 2023’’. 

6 SEC. 2. DEFINITIONS. 

7 In this Act: 


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1 (1) COVERED VETERAN.—The term ‘‘covered 

2 veteran’’ means a veteran who is enrolled in the pa3 tient enrollment system of the Department of Vet4 erans Affairs established and operated under section 

5 1705(a) of title 38, United States Code. 

6 (2) SECRETARY.—The term ‘‘Secretary’’ means 

7 the Secretary of Veterans Affairs. 

8 SEC. 3. DEPARTMENT OF VETERANS AFFAIRS LARGE9 SCALE, MIXED METHODS, RETROSPECTIVE 

10 QUALITATIVE STUDY ON THE EFFECTS OF 

11 CANNABIS ON CERTAIN HEALTH OUTCOMES 

12 OF VETERANS WITH CHRONIC PAIN AND 

13 POST-TRAUMATIC STRESS DISORDER. 

14 (a) STUDY REQUIRED.— 

15 (1) IN GENERAL.—The Secretary, through the 

16 Office of Research and Development of the Depart17 ment of Veterans Affairs, shall carry out a large18 scale, mixed methods, retrospective, and qualitative 

19 study on the effects of cannabis on the health out20 comes of covered veterans diagnosed with chronic 

21 pain and covered veterans diagnosed with post-trau22 matic stress disorder. 

23 (2) OBSERVATIONAL STUDY.—The study re24 quired by paragraph (1) shall be conducted as an 


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1 observational study on the effects of cannabis use on 

2 the health of covered veterans. 

3 (3) ELEMENTS.— 

4 (A) IN GENERAL.—The study required by 

5 paragraph (1) shall— 

6 (i) triangulate a range of data 

7 sources; 

8 (ii) compare the positive and negative 

9 health outcomes of covered veterans who 

10 use cannabis, utilizing outcomes that can 

11 be measured in an electronic health record 

12 of the Department and through data sets 

13 of the Department relating to claims for 

14 benefits under the laws administered by 

15 the Secretary; 

16 (iii) elicit the positive and negative 

17 outcomes of cannabis use for covered vet18 erans through semi-structured interviews; 

19 (iv) estimate current and future 

20 health system needs to address positive 

21 and negative outcomes of cannabis use for 

22 covered veterans; 

23 (v) include a qualitative, open-ended 

24 survey provided to covered veterans who 

25 have sought care from the Department for 


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1 chronic pain or post-traumatic stress dis2 order during the five-year period preceding 

3 the survey; and 

4 (vi) include an assessment of— 

5 (I) all records within the Vet6 erans Health Administration for cov7 ered veterans participating in the 

8 study; and 

9 (II) all records within the Vet10 erans Benefits Administration for cov11 ered veterans participating in the 

12 study. 

13 (B) HEALTH OUTCOMES.—A comparison 

14 of health outcomes under subparagraph (A)(ii) 

15 shall include an assessment of the following: 

16 (i) The reduction or increase in opiate 

17 use or dosage. 

18 (ii) The reduction or increase in 

19 benzodiazepine use or dosage. 

20 (iii) The reduction or change in use of 

21 other types of medication. 

22 (iv) The reduction or increase in alco23 hol use. 

24 (v) The reduction or increase in the 

25 prevalence of substance abuse disorders. 


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1 (vi) Sleep quality. 

2 (vii) Osteopathic pain (including pain 

3 intensity and pain-related outcomes). 

4 (viii) Agitation. 

5 (ix) Quality of life. 

6 (x) Mortality and morbidity. 

7 (xi) Hospital readmissions. 

8 (xii) Any newly developed or exacer9 bated health conditions, including mental 

10 health conditions. 

11 (b) IMPLEMENTATION.—Not later than 180 days 

12 after the date of the enactment of this Act, the Secretary 

13 shall commence the implementation of the study required 

14 by subsection (a)(1). 

15 (c) DURATION OF STUDY.—The study required by 

16 subsection (a)(1) shall be carried out for an 18-month pe17 riod. 

18 (d) REPORT.— 

19 (1) IN GENERAL.—Not later than 90 days after 

20 the completion of the study required by subsection 

21 (a)(1), the Secretary shall submit to the Committee 

22 on Veterans’ Affairs of the Senate and the Com23 mittee on Veterans’ Affairs of the House of Rep24 resentatives a report on the study. 


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1 (2) ABILITY TO CONDUCT CLINICAL TRIALS.— 

2 The Secretary shall include in the report required by 

3 paragraph (1) an assessment of whether the Sec4 retary is able to meet the criteria necessary to con5 duct the clinical trials required under section 4, in6 cluding consideration of subsection (e)(1) of such 

7 section. 

8 SEC. 4. DEPARTMENT OF VETERANS AFFAIRS CLINICAL 

9 TRIALS ON THE EFFECTS OF CANNABIS ON 

10 CERTAIN HEALTH OUTCOMES OF VETERANS 

11 WITH CHRONIC PAIN AND POST-TRAUMATIC 

12 STRESS DISORDER. 

13 (a) CLINICAL TRIALS REQUIRED.— 

14 (1) IN GENERAL.—If the Secretary indicates in 

15 the report required by section 3(d) that the Sec16 retary is able to meet the criteria necessary to pro17 ceed to clinical trials, commencing not later than 

18 180 days after the submittal of that report, the Sec19 retary shall carry out a series of clinical trials on the 

20 effects of cannabis appropriate for investigational 

21 use, as determined by the Food and Drug Adminis22 tration under section 505(i) of the Federal Food, 

23 Drug, and Cosmetic Act (21 U.S.C. 355(i)), on the 

24 health outcomes of covered veterans diagnosed with 


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1 chronic pain and covered veterans diagnosed with 

2 post-traumatic stress disorder. 

3 (2) CONSIDERATIONS.—The clinical trials re4 quired by paragraph (1) shall include, as appro5 priate, an evaluation of key symptoms, clinical out6 comes, and conditions associated with chronic pain 

7 and post-traumatic stress disorder, which may in8 clude— 

9 (A) with respect to covered veterans diag10 nosed with chronic pain, an evaluation of the 

11 effects of the use of cannabis on— 

12 (i) osteopathic pain (including pain in13 tensity and pain-related outcomes); 

14 (ii) the reduction or increase in opioid 

15 use or dosage; 

16 (iii) the reduction or increase in 

17 benzodiazepine use or dosage; 

18 (iv) the reduction or increase in alco19 hol use; 

20 (v) the reduction or increase in the 

21 prevalence of substance use disorders; 

22 (vi) inflammation; 

23 (vii) sleep quality; 

24 (viii) agitation; 

25 (ix) quality of life; 


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1 (x) exacerbated or new mental health 

2 conditions; and 

3 (xi) suicidal ideation. 

4 (B) with respect to covered veterans diag5 nosed with post-traumatic stress disorder, an 

6 evaluation of the effects of the use of cannabis 

7 on— 

8 (i) the symptoms of post-traumatic 

9 stress disorder (PTSD) as established by 

10 or derived from the clinician administered 

11 PTSD scale, the PTSD checklist, the 

12 PTSD symptom scale, the post-traumatic 

13 diagnostic scale, and other applicable 

14 methods of evaluating symptoms of post15 traumatic stress disorder; 

16 (ii) the reduction or increase in 

17 benzodiazepine use or dosage; 

18 (iii) the reduction or increase in alco19 hol use; 

20 (iv) the reduction or increase in the 

21 prevalence of substance use disorders; 

22 (v) mood; 

23 (vi) anxiety; 

24 (vii) social functioning; 

25 (viii) agitation; 


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1 (ix) suicidal ideation; and 

2 (x) sleep quality, including frequency 

3 of nightmares and night terrors. 

4 (3) OPTIONAL ELEMENTS.—The clinical trials 

5 required by paragraph (1) may include, as appro6 priate, an evaluation of the effects of the use of can7 nabis to treat chronic pain and post-traumatic stress 

8 disorder on other symptoms, clinical outcomes, and 

9 conditions not covered by paragraph (2), which may 

10 include— 

11 (A) pulmonary function; 

12 (B) cardiovascular events; 

13 (C) head, neck, and oral cancer; 

14 (D) testicular cancer; 

15 (E) ovarian cancer; 

16 (F) transitional cell cancer; 

17 (G) intestinal inflammation; 

18 (H) motor vehicle accidents; or 

19 (I) spasticity. 

20 (b) LONG-TERM OBSERVATIONAL STUDY.—The Sec21 retary may carry out a long-term observational study of 

22 the participants in the clinical trials required by sub23 section (a). 

24 (c) TYPE OF CANNABIS.— 


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1 (1) IN GENERAL.—In carrying out the clinical 

2 trials required by subsection (a), the Secretary shall 

3 study varying forms of cannabis, including whole 

4 plant raw material and extracts, and may study 

5 varying routes of administration. 

6 (2) PLANT CULTIVARS.—Of the varying forms 

7 of cannabis required under paragraph (1), the Sec8 retary shall study plant cultivars with varying ratios 

9 of tetrahydrocannabinol to cannabidiol. 

10 (d) IMPLEMENTATION.—Not later than 18 months 

11 after the date of the enactment of this Act, the Secretary 

12 shall— 

13 (1) develop a plan to implement this section 

14 and submit such plan to the Committee on Veterans’ 

15 Affairs of the Senate and the Committee on Vet16 erans’ Affairs of the House of Representatives; and 

17 (2) issue any requests for proposals the Sec18 retary determines appropriate for such implementa19 tion. 

20 (e) TERMINATION OF CLINICAL TRIALS.— 

21 (1) CLINICAL GUIDELINE REQUIREMENTS OR

22 EXCESSIVE RISK.—The Secretary may terminate the 

23 clinical trials required by subsection (a) if the Sec24 retary determines that the Department of Veterans 

25 Affairs is unable to meet clinical guideline requireVerDate Sep 11 2014 00:06 Feb 22, 2023 Jkt 039200 PO 00000 Frm 00010 Fmt 6652 Sfmt 6201 E:\BILLS\S326.IS S326

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1 ments necessary to conduct such trials or the clinical 

2 trials would create excessive risk to participants. 

3 (2) COMPLETION UPON SUBMITTAL OF FINAL

4 REPORT.—The Secretary may terminate the clinical 

5 trials required by subsection (a) upon submittal of 

6 the final report required under subsection (f)(2). 

7 (f) REPORTS.— 

8 (1) PERIODIC REPORTS.—During the five-year 

9 period beginning on the date of the commencement 

10 of clinical trials required by subsection (a), the Sec11 retary shall submit periodically, but not less fre12 quently than annually, to the Committee on Vet13 erans’ Affairs of the Senate and the Committee on 

14 Veterans’ Affairs of the House of Representatives 

15 reports on the implementation of this section. 

16 (2) FINAL REPORT.—Not later than one year 

17 after the completion of the five-year period specified 

18 in paragraph (1), the Secretary shall submit to the 

19 Committee on Veterans’ Affairs of the Senate and 

20 the Committee on Veterans’ Affairs of the House of 

21 Representatives a final report on the implementation 

22 of this section. 

23 SEC. 5. ADMINISTRATION OF STUDY AND CLINICAL TRIALS. 

24 (a) DEMOGRAPHIC REPRESENTATION.—In carrying 

25 out the study required by section 3 and the clinical trials 


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1 required by section 4, the Secretary shall ensure represen2 tation in such study and trials of demographics that rep3 resent the population of veterans in the United States, as 

4 determined by the most recently available data from the 

5 American Community Survey of the Bureau of the Census. 

6 (b) DATA PRESERVATION.—The Secretary shall en7 sure that the study required by section 3 and the clinical 

8 trials required by section 4 include a mechanism to en9 sure— 

10 (1) the preservation of all data, including all 

11 data sets and survey results, collected or used for 

12 purposes of such study and trials in a manner that 

13 will facilitate further research; and 

14 (2) registration of such data in the database of 

15 privately and publicly funded clinical studies main16 tained by the National Library of Medicine (or suc17 cessor database). 

18 (c) ANONYMOUS DATA.—The Secretary shall ensure 

19 that data relating to any study or clinical trial conducted 

20 under this Act is anonymized and cannot be traced back 

21 to an individual patient. 

22 (d) EFFECT ON OTHER BENEFITS.—The eligibility 

23 or entitlement of a covered veteran to any other benefit 

24 under the laws administered by the Secretary or any other 

25 provision of law shall not be affected by the participation 


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1 of the covered veteran in the study under section 3, a clin2 ical trial under section 4(a), or a study under section 4(b). 

3 (e) EFFECT ON OTHER LAWS.—Nothing in this Act 

4 shall affect or modify— 

5 (1) the Federal Food, Drug, and Cosmetic Act 

6 (21 U.S.C. 301 et seq.); 

7 (2) section 351 of the Public Health Service 

8 Act (42 U.S.C. 262); or 

9 (3) the authority of the Commissioner of Food 

10 and Drugs and the Secretary of Health and Human 

11 Services— 

12 (A) under— 

13 (i) the Federal Food, Drug, and Cos14 metic Act (21 U.S.C. 301 et seq.); or 

15 (ii) section 351 of the Public Health 

16 Service Act (42 U.S.C. 262); or 

17 (B) to promulgate Federal regulations and 

18 guidelines pertaining to cannabidiol, marijuana, 

19 or other subject matter addressed in this Act. 

Æ 


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