Marijuana/Cannabis
Seven Legal Marijuana Patients
• NIDA supplies marijuana to seven patients
under FDA Compassionate Use Program.
• Russo E, et al. Chronic Cannabis Use in the
Compassionate Investigational New Drug
Program: An Examination of Benefits and
Adverse Effects of Legal Clinical
Cannabis. Journal of Cannabis Therapeutics
Vol. 2 (1) (2002): 3-57. (MAPS supportedin part by grandson of W. Erastus Upjohn)
Efficacy Conclusions
• Cannabis smoking, even of a crude, lowgrade product, provides effective
symptomatic relief of pain, muscle spasms,
and intraocular pressure elevations in
selected patients failing other modes of
treatment.
• Patients reduce use of other prescription
medicines and improve quality of life.
Safety Conclusions
• Side effect profile of NIDA cannabis in
chronic usage suggests mild pulmonary risk.
• No malignant deterioration observed, nor
consistent or attributable neuropsychological
or neurological deterioration.
• No endocrine, hematological or
immunological sequelae observed.
Medical Marijuana Research
• At present, there is no research outside of
the US in which smoked marijuana is being
administered to patients in a clinical
research study.
• Research is proceeding with marijuana
extracts such as sublingual lozenges and
THC capsules (Marinol).
Dr. Abrams Marijuana/AIDS
Research
• Recently completed, this is the first FDAapproved study of the use of marijuana in
any patient population in 15 years!
• Study took 7 years to obtain approval,
MAPS worked closely with Dr. Abrams and
funded two of his NIH grant applications.
• Funded by NIDA- $1 million.
Study Design
• 21-day in-patient study, HIV+ patients
taking protease inhibitors
• Twenty-one subjects were randomized for
smoked marijuana, 25 for oral dronabinol,
and 21 for the oral placebo.
• Viral loads (HIV RNA levels), immune
system, caloric intake, weight gain.
Dr. Abrams’ conclusions
• Patients with HIV infection taking protease
inhibitors do not experience short-term
adverse virologic or immunological effects
from using smoked marijuana or oral THC as
compared to placebo.
• Caloric intake and weight gain highest in
marijuana group >oral THC > placebo.
• Paper under review
Medical Marijuana Research
• There is only one study in the US in which
smoked marijuana is being administered to
patients, in this case to AIDS patients.
• Dr. Dennis Israelski, chief of infectious
diseases and AIDS medicine at San Mateo
County Hospital and Clinics.
• Funded by San Mateo County.
Center for Medical Cannabis
Research
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Funded by the State of California
Approvals required by
CMCR
CA Research Advisory Panel
IRB
FDA
DEA
NIDA/Public Health Service
Upcoming CMCR Studies
• The Effect of Marijuana on Neuropathic
Pain in HIV-related Peripheral Neuropathy,
Donald Abrams, M.D. (UCSF)
• Placebo-controlled, Double Blind Trial of
Medicinal Cannabis in Painful HIV
Neuropathy, Ron Ellis, M.D.,Ph.D.(UCSD)
• Short-Term Effects of Cannabis Therapy on
Spasticity in MS, JodyCorey-Bloom, M.D.,
Ph.D. (UCSD)
UPCOMING CMCR Studies
• Marijuana in Combination with Opioids for
Cancer Pain, Donald Abrams, M.D.
( UCSF)
• Cannabis for Spasticity/Tremor in MS:
Placebo controlled study, Mark Agius, M.D.
(UC Davis)
• Analgesic Efficacy of Smoked Cannabis,
UPCOMING CMCR Studies
• Effects of Medicinal Cannabis on CD4
Immunity in AIDS, Rachel Schrier, Ph.D.
(UCSD)
• Mechanisms of Cannabinoid Analgesia, Ian
Meng, Ph.D. (UCSF)
• Effects of Cannabis Therapy on
Endogenous Cannabinoids, Daniele
Piomelli. Ph.D. (UC Irvine)
San Mateo County Study
• Pilot study into AIDS-related nausea, pain.
• "I know after I take a few hits that within 10
minutes I'm going to be hungry and my
nausea is going to go away," said [subject]
Alden,who suffers from chronic persistent
wasting syndrome. Nicole Achs Freeling,
Half Moon Bay Review, October 13, 2001
Lone Patient Quits Study
• "The pot was stale and it was full of seeds.
When marijuana seeds burn, they smell and
taste really bad."
• “Apparently, the two joints a day that he
was required to smoke through the study
had aggravated a throat condition. The
doctor issued an edict - no more smoking
NIDA marijuana.”
NIDA’s Product
• “We know the level of THC is lower in this
federal-provided marijuana [ than what
patients purchase through buyer’s clubs] ,
but unfortunately we don't have any control
over that. We have to use whatever we're
given by the federal government for this
study." Jonathan Messinger, assistant to
program director Dr. Dennis Israelski.
Back to Illicit Supplies
• “Once his throat condition clears, Alden
says he will go back to treating himself at
the cannabis clubs.”
• "It works. I have no doubt about that," he
said.
NIDA’s Monopoly
• NIDA has a monoply on the supply of
marijuana that can be used in FDAapproved research. This is the only
Schedule 1 drug for which NIDA has a
monopoly, not MDMA, LSD, psilocybin.
• NIDA, whose mission is to research the
harms of marijuana, must approve all
research into marijuana’s potential benefits.
NIDA Marijuana Label
NIDA Marijuana Cigarettes
NIDA likes “Pall Mall”™
Rolling Papers
Unrolled NIDA Marijuana:
Mostly Leaf
Stems and Seeds in 3 NIDASupplied Marijuana Cigarettes
MAPS/UMass Amherst
Production Facility
• 11/7/00 MAPS offers
grant to UMass Amherst
to grow 25 lb High-THC
marijuana for FDAapproved INDs.
• June 2001 Applications
filed with DEA and MA
Dept. of Public Health
• August 1,2001 MA
Inspectors come to visit
MAPS/UMass Amherst
Production Facility
• December, 2001- MA Dept. of Public
Health says it has no objections in principle.
• December, 2001- DEA says it lost the
application.
• January, 2002 - Photocopied Application
and envelope and faxed them to DEA.
• February, 2002 - DEA informed us that it
refused to accept application since there
was no original signature, just a photocopy.
MAPS/UMass Amherst
Production Facility
• March 2002 - ACLU begins to work on
legal analysis of US International treaty
obligations, which DEA informally says do
not permit non-governmental production.
(GW Pharm. does exactly this in UK)
• March 2002 - Marijuana Policy Project
begins to gather signatures from
Congressional reps on a letter to DEA
supporting private production facility.
• Application to be submitted in April 2002.
MAPS Marijuana Label
Non-Smoking Delivery System
WWW.VAPORMED.DE
Volatizer Data- Particulates
Proof of Concept Study
• Combustion THC 8.9%, CBN .27%,CBD.07%
Benzene .3%, Touluene .07%,Naphthalene 0%
• 140 C THC 5.4%, CBN .16%, CBD 0
NO Benzene, Touluene, Naphthalene
• 180 C THC 6.9%, CBN .34%, CBD 0
NO Benzene, Touluene, Naphthalene
• 200 C THC 7.7%, CBN .35%, CBD 0
NO Benzene, Touluene, Naphthalene
Volatizer - Carbon Monoxide
Proof of Principle Study
• At 170 C, Carbon Monoxide reduced at
least 1/3 compared to combustion.
• “Drager System” used to gather carbon
monoxide from combustion was saturated.
• More carbon monoxide research- $25,000
Trade-offs: Marijuana v. Extracts in
Aerosols, Drops, Sprays (GW Pharm)
• Marijuana - High THC
with vaporizer
• Safety issues, still some
particulates
• Efficacy likely equal to
other delivery systems
• Still get high
• Cost is low
• Health Effect of Wealth
• Extracts or other nonsmoking systems
• Little or no particulates
• Efficacy likely equal,
better if higher levels of
CBD,CBN are required
• Probably get high
• Cost is high
Marijuana as Symbolic Politics
• Nixon Tapes, May 26, 1971:
• "You know, it's a funny thing, every one of the
bastards that are out for legalizing marijuana is
Jewish. What the Christ is the matter with the
Jews, Bob [Haldeman]? What is the matter with
them? I suppose it is because most of them are
psychiatrists.”
• Now on to the psychiatric use of psychedelics!