What This Bill Does
This bill tells the Secretary of Veterans Affairs to run a research study and then clinical trials to see how cannabis affects veterans with chronic pain and post-traumatic stress disorder (PTSD). The study will look at both positive and negative health effects, and the clinical trials will test different types of cannabis to see if they help treat these conditions.
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Who It Affects
- Veterans enrolled in the Department of Veterans Affairs patient enrollment system
- The Department of Veterans Affairs and its Office of Research and Development
- The Food and Drug Administration
- Congressional committees overseeing veterans' affairs
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Key Provisions
- The Secretary must start a large-scale research study within 180 days that looks at health records and interviews veterans about cannabis use and its effects on chronic pain and PTSD (Sec. 3(a) and 3(b))
- The study will last 18 months and will examine changes in opioid use, sleep quality, pain levels, substance abuse, and other health outcomes (Sec. 3(c) and 3(a)(3)(B))
- If the study shows it is possible to move forward safely, the Secretary may begin clinical trials within 180 days to test different forms of cannabis, including different plant types with varying amounts of active compounds (Sec. 4(a)(1) and 4(c))
- The clinical trials will evaluate how cannabis affects PTSD symptoms, pain, mood, anxiety, sleep, and risk of suicidal thoughts, and will run for five years with annual progress reports (Sec. 4(a)(2) and 4(f)(1))
- The Secretary must ensure the study and trials include veterans that represent the overall veteran population and must keep all patient data anonymous (Sec. 5(a) and 5(c))
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What Changes
If this bill becomes law, the Veterans Affairs department will begin researching how cannabis affects veterans with chronic pain and PTSD. Veterans participating in the study will not lose any other benefits they receive. The research may eventually lead to clinical trials testing cannabis as a treatment, though this only happens if the initial study shows it is safe and feasible to proceed.
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Important Definitions
- **Covered veteran:** A veteran enrolled in the Veterans Affairs patient enrollment system (Sec. 2(1))
- **Secretary:** The Secretary of Veterans Affairs (Sec. 2(2))
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Effective Date
Not specified in bill text
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 pur-
poses.
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 pur-
poses.
Be it enacted by the Senate and House of Representa-
1
tives of the United States of America in Congress assembled,
2
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SECTION 1. SHORT TITLE.
1
This Act may be cited as the ‘‘VA Medicinal Cannabis
2
Research Act of 2023’’.
3
SEC. 2. DEFINITIONS.
4
In this Act:
5
(1) COVERED
VETERAN.—The term ‘‘covered
6
veteran’’ means a veteran who is enrolled in the pa-
7
tient enrollment system of the Department of Vet-
8
erans Affairs established and operated under section
9
1705(a) of title 38, United States Code.
10
(2) SECRETARY.—The term ‘‘Secretary’’ means
11
the Secretary of Veterans Affairs.
12
SEC. 3. DEPARTMENT OF VETERANS AFFAIRS LARGE-
13
SCALE, MIXED METHODS, RETROSPECTIVE
14
QUALITATIVE STUDY ON THE EFFECTS OF
15
CANNABIS ON CERTAIN HEALTH OUTCOMES
16
OF VETERANS WITH CHRONIC PAIN AND
17
POST-TRAUMATIC STRESS DISORDER.
18
(a) STUDY REQUIRED.—
19
(1) IN GENERAL.—The Secretary, through the
20
Office of Research and Development of the Depart-
21
ment of Veterans Affairs, shall carry out a large-
22
scale, mixed methods, retrospective, and qualitative
23
study on the effects of cannabis on the health out-
24
comes of covered veterans diagnosed with chronic
25
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pain and covered veterans diagnosed with post-trau-
1
matic stress disorder.
2
(2) OBSERVATIONAL
STUDY.—The study re-
3
quired by paragraph (1) shall be conducted as an
4
observational study on the effects of cannabis use on
5
the health of covered veterans.
6
(3) ELEMENTS.—
7
(A) IN GENERAL.—The study required by
8
paragraph (1) shall—
9
(i) triangulate a range of data
10
sources;
11
(ii) compare the positive and negative
12
health outcomes of covered veterans who
13
use cannabis, utilizing outcomes that can
14
be measured in an electronic health record
15
of the Department and through data sets
16
of the Department relating to claims for
17
benefits under the laws administered by
18
the Secretary;
19
(iii) elicit the positive and negative
20
outcomes of cannabis use for covered vet-
21
erans through semi-structured interviews;
22
(iv) estimate current and future
23
health system needs to address positive
24
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and negative outcomes of cannabis use for
1
covered veterans;
2
(v) include a qualitative, open-ended
3
survey provided to covered veterans who
4
have sought care from the Department for
5
chronic pain or post-traumatic stress dis-
6
order during the five-year period preceding
7
the survey; and
8
(vi) include an assessment of—
9
(I) all records within the Vet-
10
erans Health Administration for cov-
11
ered veterans participating in the
12
study; and
13
(II) all records within the Vet-
14
erans Benefits Administration for cov-
15
ered veterans participating in the
16
study.
17
(B) HEALTH
OUTCOMES.—A comparison
18
of health outcomes under subparagraph (A)(ii)
19
shall include an assessment of the following:
20
(i) The reduction or increase in opiate
21
use or dosage.
22
(ii) The reduction or increase in
23
benzodiazepine use or dosage.
24
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(iii) The reduction or change in use of
1
other types of medication.
2
(iv) The reduction or increase in alco-
3
hol use.
4
(v) The reduction or increase in the
5
prevalence of substance abuse disorders.
6
(vi) Sleep quality.
7
(vii) Osteopathic pain (including pain
8
intensity and pain-related outcomes).
9
(viii) Agitation.
10
(ix) Quality of life.
11
(x) Mortality and morbidity.
12
(xi) Hospital readmissions.
13
(xii) Any newly developed or exacer-
14
bated health conditions, including mental
15
health conditions.
16
(b) IMPLEMENTATION.—Not later than 180 days
17
after the date of the enactment of this Act, the Secretary
18
shall commence the implementation of the study required
19
by subsection (a)(1).
20
(c) DURATION OF STUDY.—The study required by
21
subsection (a)(1) shall be carried out for an 18-month pe-
22
riod.
23
(d) REPORT.—
24
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(1) IN GENERAL.—Not later than 90 days after
1
the completion of the study required by subsection
2
(a)(1), the Secretary shall submit to the Committee
3
on Veterans’ Affairs of the Senate and the Com-
4
mittee on Veterans’ Affairs of the House of Rep-
5
resentatives a report on the study.
6
(2) ABILITY TO CONDUCT CLINICAL TRIALS.—
7
The Secretary shall include in the report required by
8
paragraph (1) an assessment of whether the Sec-
9
retary is able to meet the criteria necessary to con-
10
duct the clinical trials required under section 4, in-
11
cluding consideration of subsection (e)(1) of such
12
section.
13
SEC. 4. DEPARTMENT OF VETERANS AFFAIRS CLINICAL
14
TRIALS ON THE EFFECTS OF CANNABIS ON
15
CERTAIN HEALTH OUTCOMES OF VETERANS
16
WITH CHRONIC PAIN AND POST-TRAUMATIC
17
STRESS DISORDER.
18
(a) CLINICAL TRIALS REQUIRED.—
19
(1) IN GENERAL.—If the Secretary indicates in
20
the report required by section 3(d) that the Sec-
21
retary is able to meet the criteria necessary to pro-
22
ceed to clinical trials, commencing not later than
23
180 days after the submittal of that report, the Sec-
24
retary shall carry out a series of clinical trials on the
25
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effects of cannabis appropriate for investigational
1
use, as determined by the Food and Drug Adminis-
2
tration under section 505(i) of the Federal Food,
3
Drug, and Cosmetic Act (21 U.S.C. 355(i)), on the
4
health outcomes of covered veterans diagnosed with
5
chronic pain and covered veterans diagnosed with
6
post-traumatic stress disorder.
7
(2) CONSIDERATIONS.—The clinical trials re-
8
quired by paragraph (1) shall include, as appro-
9
priate, an evaluation of key symptoms, clinical out-
10
comes, and conditions associated with chronic pain
11
and post-traumatic stress disorder, which may in-
12
clude—
13
(A) with respect to covered veterans diag-
14
nosed with chronic pain, an evaluation of the
15
effects of the use of cannabis on—
16
(i) osteopathic pain (including pain in-
17
tensity and pain-related outcomes);
18
(ii) the reduction or increase in opioid
19
use or dosage;
20
(iii) the reduction or increase in
21
benzodiazepine use or dosage;
22
(iv) the reduction or increase in alco-
23
hol use;
24
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(v) the reduction or increase in the
1
prevalence of substance use disorders;
2
(vi) inflammation;
3
(vii) sleep quality;
4
(viii) agitation;
5
(ix) quality of life;
6
(x) exacerbated or new mental health
7
conditions; and
8
(xi) suicidal ideation.
9
(B) with respect to covered veterans diag-
10
nosed with post-traumatic stress disorder, an
11
evaluation of the effects of the use of cannabis
12
on—
13
(i) the symptoms of post-traumatic
14
stress disorder (PTSD) as established by
15
or derived from the clinician administered
16
PTSD scale, the PTSD checklist, the
17
PTSD symptom scale, the post-traumatic
18
diagnostic scale, and other applicable
19
methods of evaluating symptoms of post-
20
traumatic stress disorder;
21
(ii) the reduction or increase in
22
benzodiazepine use or dosage;
23
(iii) the reduction or increase in alco-
24
hol use;
25
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(iv) the reduction or increase in the
1
prevalence of substance use disorders;
2
(v) mood;
3
(vi) anxiety;
4
(vii) social functioning;
5
(viii) agitation;
6
(ix) suicidal ideation; and
7
(x) sleep quality, including frequency
8
of nightmares and night terrors.
9
(3) OPTIONAL ELEMENTS.—The clinical trials
10
required by paragraph (1) may include, as appro-
11
priate, an evaluation of the effects of the use of can-
12
nabis to treat chronic pain and post-traumatic stress
13
disorder on other symptoms, clinical outcomes, and
14
conditions not covered by paragraph (2), which may
15
include—
16
(A) pulmonary function;
17
(B) cardiovascular events;
18
(C) head, neck, and oral cancer;
19
(D) testicular cancer;
20
(E) ovarian cancer;
21
(F) transitional cell cancer;
22
(G) intestinal inflammation;
23
(H) motor vehicle accidents; or
24
(I) spasticity.
25
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(b) LONG-TERM OBSERVATIONAL STUDY.—The Sec-
1
retary may carry out a long-term observational study of
2
the participants in the clinical trials required by sub-
3
section (a).
4
(c) TYPE OF CANNABIS.—
5
(1) IN GENERAL.—In carrying out the clinical
6
trials required by subsection (a), the Secretary shall
7
study varying forms of cannabis, including whole
8
plant raw material and extracts, and may study
9
varying routes of administration.
10
(2) PLANT CULTIVARS.—Of the varying forms
11
of cannabis required under paragraph (1), the Sec-
12
retary shall study plant cultivars with varying ratios
13
of tetrahydrocannabinol to cannabidiol.
14
(d) IMPLEMENTATION.—Not later than 18 months
15
after the date of the enactment of this Act, the Secretary
16
shall—
17
(1) develop a plan to implement this section
18
and submit such plan to the Committee on Veterans’
19
Affairs of the Senate and the Committee on Vet-
20
erans’ Affairs of the House of Representatives; and
21
(2) issue any requests for proposals the Sec-
22
retary determines appropriate for such implementa-
23
tion.
24
(e) TERMINATION OF CLINICAL TRIALS.—
25
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(1) CLINICAL
GUIDELINE
REQUIREMENTS
OR
1
EXCESSIVE RISK.—The Secretary may terminate the
2
clinical trials required by subsection (a) if the Sec-
3
retary determines that the Department of Veterans
4
Affairs is unable to meet clinical guideline require-
5
ments necessary to conduct such trials or the clinical
6
trials would create excessive risk to participants.
7
(2) COMPLETION UPON SUBMITTAL OF FINAL
8
REPORT.—The Secretary may terminate the clinical
9
trials required by subsection (a) upon submittal of
10
the final report required under subsection (f)(2).
11
(f) REPORTS.—
12
(1) PERIODIC REPORTS.—During the five-year
13
period beginning on the date of the commencement
14
of clinical trials required by subsection (a), the Sec-
15
retary shall submit periodically, but not less fre-
16
quently than annually, to the Committee on Vet-
17
erans’ Affairs of the Senate and the Committee on
18
Veterans’ Affairs of the House of Representatives
19
reports on the implementation of this section.
20
(2) FINAL REPORT.—Not later than one year
21
after the completion of the five-year period specified
22
in paragraph (1), the Secretary shall submit to the
23
Committee on Veterans’ Affairs of the Senate and
24
the Committee on Veterans’ Affairs of the House of
25
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Representatives a final report on the implementation
1
of this section.
2
SEC. 5. ADMINISTRATION OF STUDY AND CLINICAL TRIALS.
3
(a) DEMOGRAPHIC REPRESENTATION.—In carrying
4
out the study required by section 3 and the clinical trials
5
required by section 4, the Secretary shall ensure represen-
6
tation in such study and trials of demographics that rep-
7
resent the population of veterans in the United States, as
8
determined by the most recently available data from the
9
American Community Survey of the Bureau of the Census.
10
(b) DATA PRESERVATION.—The Secretary shall en-
11
sure that the study required by section 3 and the clinical
12
trials required by section 4 include a mechanism to en-
13
sure—
14
(1) the preservation of all data, including all
15
data sets and survey results, collected or used for
16
purposes of such study and trials in a manner that
17
will facilitate further research; and
18
(2) registration of such data in the database of
19
privately and publicly funded clinical studies main-
20
tained by the National Library of Medicine (or suc-
21
cessor database).
22
(c) ANONYMOUS DATA.—The Secretary shall ensure
23
that data relating to any study or clinical trial conducted
24
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under this Act is anonymized and cannot be traced back
1
to an individual patient.
2
(d) EFFECT ON OTHER BENEFITS.—The eligibility
3
or entitlement of a covered veteran to any other benefit
4
under the laws administered by the Secretary or any other
5
provision of law shall not be affected by the participation
6
of the covered veteran in the study under section 3, a clin-
7
ical trial under section 4(a), or a study under section 4(b).
8
(e) EFFECT ON OTHER LAWS.—Nothing in this Act
9
shall affect or modify—
10
(1) the Federal Food, Drug, and Cosmetic Act
11
(21 U.S.C. 301 et seq.);
12
(2) section 351 of the Public Health Service
13
Act (42 U.S.C. 262); or
14
(3) the authority of th
[Text truncated for display. Full text available on Congress.gov.]