Journal of the California Cannabis Research Medical
Center for Medicinal Cannabis
Has 18 State-Funded Studies in the Pipeline
By Dale Gieringer
While U.S. government drug bureaucrats are loudly demanding rigorous scientific
evidence for the medical efficacy of marijuana, the California Center for Medicinal
Cannabis Research is quietly sponsoring an ambitious program of controlled
clinical studies to help shed light on the issue.
The CMCR, headquartered at the University of California San Diego, now has
14 clinical studies of medical cannabis under way, plus four more undergoing
review by regulatory authorities. Included are the first human efficacy studies
of smoked natural cannabis for medical purposes since such research was shut
down by the Reagan administration in the early 1980s.
The CMCR was established by the state legislature under the Marijuana Research
Act of 1999. The act was sponsored by Sen. John Vasconcellos with support from
former Attorney General Dan Lungren, a leading opponent of Prop. 215, on the
grounds that more research was needed on the medical value of marijuana. Under
the act, the CMCR was directed to "develop and conduct studies to ascertain
the general medical safety and efficacy of marijuana and, if found valuable
...[to] develop medical guidelines for the appropriate administration and use
CMCR researchers are currently conducting placebo-controlled efficacy studies
of smoked cannabis for treatment of HIV-related peripheral neuropathy, spasticity
and tremors due to multiple sclerosis, and cancer pain and nausea. The cannabis
used in the study is grown in Mississippi under license from the Drug Enforcement
Administration and provided to the researchers by the National Institute on
In one study, Dr. Donald Abrams of UCSF is examining the combination of cannabis
with opiates for treatment of cancer pain. In another, Suzanne Dibble of UCSF
is comparing smoked cannabis, oral Marinol, and smoked and oral placebos in
the treatment of nausea from cancer chemotherapy. Other CMCR investigators
are examining the effects of cannabis on driving ability, sleeping patterns,
and artificially induced pain and neuropathy.
The CMCR has also approved groundbreaking studies on two new modes of cannabis
administration: vaporization and an oral cannabis spray. The FDA has given
approval for what would be the first-ever human trial using a cannabis vaporizer,
the Volcano(r) (http://www.vapormed.de), in a dosage study of healthy subjects
The FDA has also approved the first U.S. study of an oral cannabis extract
manufactured by GW Pharmaceuticals (http://www.gwpharm.com), a British company
whose product may be approved this spring by U.K. authorities. The study, by
Dr. Ronald Ellis of UCSD, will examine patients with HIV neuropathic pain.
Both studies are still awaiting final DEA approval.
Several CMCR studies are aimed at uncovering the basic mechanisms through which
cannabinoids achieve their effects within the body. Daniele Piomelli of UCSD
is trying to
determine the impact of external cannabinoids -smoked
or otherwise ingested- on the body's own endogenous cannabinoid system.
Piomelli's hypothesis is that "long-term cannabis and THC administration
interfere with activity of the en-docannabinoid system."
Piomelli's group will use a technique called high performance liquid chromatography/mass
spectrometry to test blood plasma samples obtained from patients in a CMCR
clinical study. They expect the introduction of smoked cannabinois to decrease
the rate at which natural, fat-derived endocannabinoid compounds are produced,
circulate, and/or interact with receptors.
" Brain neurotransmitter systems are highly plastic and regulate their activity
when they are challenged with exogenous drugs," writes Piomelli. "We
hypothesize that treatment with cannabis or D 9-THC may produce compensatory
changes in the activity of the endocannabinoid system. Such changes might in
turn influence in important ways the therapeutic outcome of cannabinoid therapy
and participate in withdrawal phenomena after drug cessation."
Abrams's First Study Published
So far, only one CMCR study has released published results.
In a pilot study of patients with HIV-related peripheral neuropathy,
Dr. Donald Abrams found that 10 out of 16 subjects reported a greater
than 30% reduction in pain after seven days of treatment. Based on
these promising results, Dr. Abrams is proceeding with a randomized
placebo-controlled trial with 50 subjects.
Researchers say it will be a year or two before more study results become available.
Progress has been slow on account of the rigors and regulatory delays of modern
controlled clinical research. Every study must be reviewed and approved by
a gamut of regulatory agencies: the FDA, DEA, NIDA, the California Research
Advisory Panel and an institutional review board.
Unlike other, independent research entities that have been denied approval
for medical cannabis research, the CMCR has enjoyed good relations with federal
regulators at the DEA and NIDA. The DEA went so far as to issue a press release
crowing about its approval of the first two research applications by CMCR researchers.
Despite this, it still took nearly a year for NIDA's cannabis to reach the
hands of CMCR researchers.
Researchers must entice AIDS and cancer patients to volunteer
for studies in which they receive low-grade NIDA cannabis or placebo
in a cloistered clinical setting.
Another problem delaying CMCR researchers has been the
difficulty of recruiting human subjects. Given that high-grade cannabis
is already widely available to patients in California under Prop. 215,
researchers have been hard pressed to entice AIDS and cancer patients
to volunteer for controlled studies in which they receive low-grade
NIDA cannabis or placebo in a cloistered clinical setting. Recruitment
has proceeded at a snail's pace.
The CMCR was originally conceived as a three-year program. This year, the legislature
voted to extend its mandate indefinitely. Its existing research program has
been funded by legislative appropriations totaling $8.75 million over the past
three years. No further funding is expected until more study results are announced.
Should the CMCR studies confirm that cannabis does have medical efficacy -as
widely expected by knowledgeable observers- government regulators may finally
be forced to revise federal policy. DEA, NIDA and ONDCP officials have repeatedly
claimed that controlled scientific studies are essential to changing the Schedule
One status of marijuana.
In the words of former DEA Commissioner Asa Hutchinson, "The question
of whether marijuana has any legitimate medical purpose should be determined
by sound science and medicine."
Speaking at the Commonwealth Club in San Francisco, Hutchinson boasted that
his agency had authorized CMCR researchers to conduct safety and efficacy studies
of medical marijuana. "The DEA realizes how important it is to keep listening
to science," Hutchinson assured his audience. The proof will be in the
||Title of Approved Study
|Donald Abrams, MD
||Cannabis for Treatment of HIV-Related Peripheral Neuropathy
|Donald Abrams, MD
||Cannabis in Combination With Opioids for Cancer Pain
|Mark Agius, MD
||Cannabis for Spasticity/Tremor in MS: Placebo-controlled study
|Jody Corey-Bloom, MD
||Short-Term Effects of Cannabis Therapy on Spasticity in MS
|Suzanne L. Dibble, DNSc, RN
||Treating Chemotherapy-Induced Delay Nausea with Cannabinoids
|Sean Drummond, PhD
||Sleep and Medicinal Cannabis
|Ronald Ellis, MD, PhD
||Placebo-Controlled Double-Blind Trial of Medicinal Cannabis in
Painful HIV Neuropathy
|Dennis Israelski, MD
||San Mateo County
||MMJ for HIV-associated DSPN: Adherence & Compliance Sub-study
|Thomas Marcotte, PhD
||Impact of Repeated Cannabis Treatments on Driving Abilities
|Ian Meng, PhD
||Mechanisms of Cannabinoid Analgesia
|Daniele Piomelli, PhD
||Effects of Cannabis Therapy on Endogenous Cannabinoids
||Effects of Medicinal Cannabis on CD4 Immunity in AIDS
|Mike Wallace, MD
||Analgesic Efficacy of Smoked Cannabis
|Barth Wilsey, MD
||Double-Blind, Palcebo Controlled Trial of Smoked Marijuana on
|| Studies Undergoing State and Federal Review
|Donald Abrams, MD
||Vaporization as a Smokeless Cannabis Delivery System
|Mark Barad, MD, PhD
||Cannabinoids in Fear Extinction
|Ronald J. Ellis, MD, PhD
||UCSD Placebo-Controlled, Double-Blind Trial of Cannabis-Based
Medicine Extract (CBME) in Painful HIV Neuropathy
|Mark Wallace, MD
||Analgesic Efficacy of Smoked Cannabis in Refractory Cancer Pain
is the journal of the CCRMG/SCC. Our primary goals are the same
as the stated goals of any
reputable scientific publication: to bring out findings that are
accurate, duplicable, and useful to the community at large. But in
order to do this, we have to pursue parallel goals such as removing
the impediments to clinical research created by Prohibition, and
educating our colleagues, co-workers and patients as we educate ourselves
about the medical uses of cannabis.
| The Society
of Cannabis Clinicians (SCC) was formed in the Autumn of 2004 by
the member physicians of CCRMG
to aid in the promulgation of voluntary standards for clinicians
engaged in the recommendation and approval of cannabis under California
law (HSC §11362.5).
As the collaborative effort continues to move closer to issueing
guidelines, this site serves as a public venue for airing and
discussing these guidelines.
Visit the SCC Site for more information.