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.