[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[S. 1467 Introduced in Senate (IS)]
<DOC>
117th CONGRESS
1st Session
S. 1467
To direct the Secretary of Veterans Affairs to carry out a series of
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
April 29, 2021
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 series of
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.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``VA Medicinal Cannabis Research Act
of 2021''.
SEC. 2. 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.--The Secretary of Veterans Affairs shall
carry out a series of clinical trials on the effects of
medical-grade cannabis on the health outcomes of covered
veterans diagnosed with chronic pain and covered veterans
diagnosed with post-traumatic stress disorder.
(2) Required elements.--The clinical trials required by
paragraph (1) shall 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) inflammation;
(vi) sleep quality;
(vii) agitation; and
(viii) quality of life;
(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) mood;
(v) anxiety;
(vi) social functioning;
(vii) agitation;
(viii) suicidal ideation; and
(ix) sleep quality, including frequency of
nightmares and night terrors.
(3) Optional elements.--The clinical trials required by
paragraph (1) may include an evaluation of the effects of the
use of cannabis to treat chronic pain and post-traumatic stress
disorder on--
(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;
(I) mania;
(J) psychosis;
(K) cognitive effects;
(L) cannabinoid hyperemesis syndrome;
(M) neuropathy; or
(N) 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.
(2) Plant cultivars.--Of the varying forms of cannabis
required under paragraph (1), the Secretary shall study not
fewer than seven unique plant cultivars with ratios of
tetrahydrocannabinol to cannabidiol in each of the following
categories:
(A) Less than 1:5.
(B) Between 1:2 and 1:5.
(C) Approximately 1:2.
(D) Approximately 1:1.
(E) Approximately 2:1.
(F) Between 2:1 and 5:1.
(G) More than 5:1.
(d) Use of Control and Experimental Groups.--The clinical trials
required by subsection (a) shall include both a control group and an
experimental group that shall--
(1) be of similar size and structure; and
(2) represent the demographics of the veteran population,
as determined by the most recent data from the American
Community Survey of the Bureau of the Census that is available
prior to the commencement of the clinical trials.
(e) Data Preservation.--The clinical trials required by subsection
(a) shall include a mechanism to ensure the preservation of all data,
including all data sets, collected or used for purposes of such trials
in a manner that will facilitate further research.
(f) Implementation.--Not later than 180 days 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.
(g) Effect on Other Benefits.--The eligibility or entitlement of a
covered veteran to any other benefit under the laws administered by the
Secretary or any other provision of law shall not be affected by the
participation of the covered veteran in a clinical trial under
subsection (a) or a study under subsection (b).
(h) Periodic Reports.--During the five-year period beginning on the
date of the enactment of this Act, 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.
(i) Covered Veteran Defined.--In this section, the term ``covered
veteran'' means a veteran who is enrolled in the patient enrollment
system of the Department of Veterans Affairs established and operated
under section 1705(a) of title 38, United States Code.
<all>