II 

Calendar No. 32 

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, Mr. SULLIVAN, and Ms. DUCKWORTH) introduced 

the following bill; which was read twice and referred to the Committee 

on Veterans’ Affairs 

MARCH 23, 2023 

Reported by Mr. TESTER, without amendment 

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, 


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1 SECTION 1. SHORT TITLE. 

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

3 Research Act of 2023’’. 

4 SEC. 2. DEFINITIONS. 

5 In this Act: 

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

7 veteran’’ means a veteran who is enrolled in the pa8 tient enrollment system of the Department of Vet9 erans Affairs established and operated under section 

10 1705(a) of title 38, United States Code. 

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

12 the Secretary of Veterans Affairs. 

13 SEC. 3. DEPARTMENT OF VETERANS AFFAIRS LARGE14 SCALE, MIXED METHODS, RETROSPECTIVE 

15 QUALITATIVE STUDY ON THE EFFECTS OF 

16 CANNABIS ON CERTAIN HEALTH OUTCOMES 

17 OF VETERANS WITH CHRONIC PAIN AND 

18 POST-TRAUMATIC STRESS DISORDER. 

19 (a) STUDY REQUIRED.— 

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

21 Office of Research and Development of the Depart22 ment of Veterans Affairs, shall carry out a large23 scale, mixed methods, retrospective, and qualitative 

24 study on the effects of cannabis on the health out25 comes of covered veterans diagnosed with chronic 


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1 pain and covered veterans diagnosed with post-trau2 matic stress disorder. 

3 (2) OBSERVATIONAL STUDY.—The study re4 quired by paragraph (1) shall be conducted as an 

5 observational study on the effects of cannabis use on 

6 the health of covered veterans. 

7 (3) ELEMENTS.— 

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

9 paragraph (1) shall— 

10 (i) triangulate a range of data 

11 sources; 

12 (ii) compare the positive and negative 

13 health outcomes of covered veterans who 

14 use cannabis, utilizing outcomes that can 

15 be measured in an electronic health record 

16 of the Department and through data sets 

17 of the Department relating to claims for 

18 benefits under the laws administered by 

19 the Secretary; 

20 (iii) elicit the positive and negative 

21 outcomes of cannabis use for covered vet22 erans through semi-structured interviews; 

23 (iv) estimate current and future 

24 health system needs to address positive 


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1 and negative outcomes of cannabis use for 

2 covered veterans; 

3 (v) include a qualitative, open-ended 

4 survey provided to covered veterans who 

5 have sought care from the Department for 

6 chronic pain or post-traumatic stress dis7 order during the five-year period preceding 

8 the survey; and 

9 (vi) include an assessment of— 

10 (I) all records within the Vet11 erans Health Administration for cov12 ered veterans participating in the 

13 study; and 

14 (II) all records within the Vet15 erans Benefits Administration for cov16 ered veterans participating in the 

17 study. 

18 (B) HEALTH OUTCOMES.—A comparison 

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

20 shall include an assessment of the following: 

21 (i) The reduction or increase in opiate 

22 use or dosage. 

23 (ii) The reduction or increase in 

24 benzodiazepine use or dosage. 


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1 (iii) The reduction or change in use of 

2 other types of medication. 

3 (iv) The reduction or increase in alco4 hol use. 

5 (v) The reduction or increase in the 

6 prevalence of substance abuse disorders. 

7 (vi) Sleep quality. 

8 (vii) Osteopathic pain (including pain 

9 intensity and pain-related outcomes). 

10 (viii) Agitation. 

11 (ix) Quality of life. 

12 (x) Mortality and morbidity. 

13 (xi) Hospital readmissions. 

14 (xii) Any newly developed or exacer15 bated health conditions, including mental 

16 health conditions. 

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

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

19 shall commence the implementation of the study required 

20 by subsection (a)(1). 

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

22 subsection (a)(1) shall be carried out for an 18-month pe23 riod. 

24 (d) REPORT.— 


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

2 the completion of the study required by subsection 

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

4 on Veterans’ Affairs of the Senate and the Com5 mittee on Veterans’ Affairs of the House of Rep6 resentatives a report on the study. 

7 (2) ABILITY TO CONDUCT CLINICAL TRIALS.— 

8 The Secretary shall include in the report required by 

9 paragraph (1) an assessment of whether the Sec10 retary is able to meet the criteria necessary to con11 duct the clinical trials required under section 4, in12 cluding consideration of subsection (e)(1) of such 

13 section. 

14 SEC. 4. DEPARTMENT OF VETERANS AFFAIRS CLINICAL 

15 TRIALS ON THE EFFECTS OF CANNABIS ON 

16 CERTAIN HEALTH OUTCOMES OF VETERANS 

17 WITH CHRONIC PAIN AND POST-TRAUMATIC 

18 STRESS DISORDER. 

19 (a) CLINICAL TRIALS REQUIRED.— 

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

21 the report required by section 3(d) that the Sec22 retary is able to meet the criteria necessary to pro23 ceed to clinical trials, commencing not later than 

24 180 days after the submittal of that report, the Sec25 retary shall carry out a series of clinical trials on the 


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1 effects of cannabis appropriate for investigational 

2 use, as determined by the Food and Drug Adminis3 tration under section 505(i) of the Federal Food, 

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

5 health outcomes of covered veterans diagnosed with 

6 chronic pain and covered veterans diagnosed with 

7 post-traumatic stress disorder. 

8 (2) CONSIDERATIONS.—The clinical trials re9 quired by paragraph (1) shall include, as appro10 priate, an evaluation of key symptoms, clinical out11 comes, and conditions associated with chronic pain 

12 and post-traumatic stress disorder, which may in13 clude— 

14 (A) with respect to covered veterans diag15 nosed with chronic pain, an evaluation of the 

16 effects of the use of cannabis on— 

17 (i) osteopathic pain (including pain in18 tensity and pain-related outcomes); 

19 (ii) the reduction or increase in opioid 

20 use or dosage; 

21 (iii) the reduction or increase in 

22 benzodiazepine use or dosage; 

23 (iv) the reduction or increase in alco24 hol use; 


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1 (v) the reduction or increase in the 

2 prevalence of substance use disorders; 

3 (vi) inflammation; 

4 (vii) sleep quality; 

5 (viii) agitation; 

6 (ix) quality of life; 

7 (x) exacerbated or new mental health 

8 conditions; and 

9 (xi) suicidal ideation. 

10 (B) with respect to covered veterans diag11 nosed with post-traumatic stress disorder, an 

12 evaluation of the effects of the use of cannabis 

13 on— 

14 (i) the symptoms of post-traumatic 

15 stress disorder (PTSD) as established by 

16 or derived from the clinician administered 

17 PTSD scale, the PTSD checklist, the 

18 PTSD symptom scale, the post-traumatic 

19 diagnostic scale, and other applicable 

20 methods of evaluating symptoms of post21 traumatic stress disorder; 

22 (ii) the reduction or increase in 

23 benzodiazepine use or dosage; 

24 (iii) the reduction or increase in alco25 hol use; 


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1 (iv) the reduction or increase in the 

2 prevalence of substance use disorders; 

3 (v) mood; 

4 (vi) anxiety; 

5 (vii) social functioning; 

6 (viii) agitation; 

7 (ix) suicidal ideation; and 

8 (x) sleep quality, including frequency 

9 of nightmares and night terrors. 

10 (3) OPTIONAL ELEMENTS.—The clinical trials 

11 required by paragraph (1) may include, as appro12 priate, an evaluation of the effects of the use of can13 nabis to treat chronic pain and post-traumatic stress 

14 disorder on other symptoms, clinical outcomes, and 

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

16 include— 

17 (A) pulmonary function; 

18 (B) cardiovascular events; 

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

20 (D) testicular cancer; 

21 (E) ovarian cancer; 

22 (F) transitional cell cancer; 

23 (G) intestinal inflammation; 

24 (H) motor vehicle accidents; or 

25 (I) spasticity. 


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1 (b) LONG-TERM OBSERVATIONAL STUDY.—The Sec2 retary may carry out a long-term observational study of 

3 the participants in the clinical trials required by sub4 section (a). 

5 (c) TYPE OF CANNABIS.— 

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

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

8 study varying forms of cannabis, including whole 

9 plant raw material and extracts, and may study 

10 varying routes of administration. 

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

12 of cannabis required under paragraph (1), the Sec13 retary shall study plant cultivars with varying ratios 

14 of tetrahydrocannabinol to cannabidiol. 

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

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

17 shall— 

18 (1) develop a plan to implement this section 

19 and submit such plan to the Committee on Veterans’ 

20 Affairs of the Senate and the Committee on Vet21 erans’ Affairs of the House of Representatives; and 

22 (2) issue any requests for proposals the Sec23 retary determines appropriate for such implementa24 tion. 

25 (e) TERMINATION OF CLINICAL TRIALS.— 


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1 (1) CLINICAL GUIDELINE REQUIREMENTS OR

2 EXCESSIVE RISK.—The Secretary may terminate the 

3 clinical trials required by subsection (a) if the Sec4 retary determines that the Department of Veterans 

5 Affairs is unable to meet clinical guideline require6 ments necessary to conduct such trials or the clinical 

7 trials would create excessive risk to participants. 

8 (2) COMPLETION UPON SUBMITTAL OF FINAL

9 REPORT.—The Secretary may terminate the clinical 

10 trials required by subsection (a) upon submittal of 

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

12 (f) REPORTS.— 

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

14 period beginning on the date of the commencement 

15 of clinical trials required by subsection (a), the Sec16 retary shall submit periodically, but not less fre17 quently than annually, to the Committee on Vet18 erans’ Affairs of the Senate and the Committee on 

19 Veterans’ Affairs of the House of Representatives 

20 reports on the implementation of this section. 

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

22 after the completion of the five-year period specified 

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

24 Committee on Veterans’ Affairs of the Senate and 

25 the Committee on Veterans’ Affairs of the House of 


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1 Representatives a final report on the implementation 

2 of this section. 

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

4 (a) DEMOGRAPHIC REPRESENTATION.—In carrying 

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

6 required by section 4, the Secretary shall ensure represen7 tation in such study and trials of demographics that rep8 resent the population of veterans in the United States, as 

9 determined by the most recently available data from the 

10 American Community Survey of the Bureau of the Census. 

11 (b) DATA PRESERVATION.—The Secretary shall en12 sure that the study required by section 3 and the clinical 

13 trials required by section 4 include a mechanism to en14 sure— 

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

16 data sets and survey results, collected or used for 

17 purposes of such study and trials in a manner that 

18 will facilitate further research; and 

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

20 privately and publicly funded clinical studies main21 tained by the National Library of Medicine (or suc22 cessor database). 

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

24 that data relating to any study or clinical trial conducted 


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1 under this Act is anonymized and cannot be traced back 

2 to an individual patient. 

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

4 or entitlement of a covered veteran to any other benefit 

5 under the laws administered by the Secretary or any other 

6 provision of law shall not be affected by the participation 

7 of the covered veteran in the study under section 3, a clin8 ical trial under section 4(a), or a study under section 4(b). 

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

10 shall affect or modify— 

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

12 (21 U.S.C. 301 et seq.); 

13 (2) section 351 of the Public Health Service 

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

15 (3) the authority of the Commissioner of Food 

16 and Drugs and the Secretary of Health and Human 

17 Services— 

18 (A) under— 

19 (i) the Federal Food, Drug, and Cos20 metic Act (21 U.S.C. 301 et seq.); or 

21 (ii) section 351 of the Public Health 

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

23 (B) to promulgate Federal regulations and 

24 guidelines pertaining to cannabidiol, marijuana, 

25 or other subject matter addressed in this Act. 


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Calendar No. 32 

118TH CONGRESS 

1ST SESSION S. 326 

A BILL 

To direct the Secretary of Veterans Affairs to carry 

order, and for other purposes. with chronic pain and post-traumatic stress discannabis on certain health outcomes of veterans out a study and clinical trials on the effects of 

MARCH 23, 2023 

Reported without amendment 


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