HIV-POSITIVE PARTICIPANTS SOUGHT FOR MEDICAL MARIJUANA STUDY

Not just free pot - subjects get $1,000!

Dr. Donald Abrams and colleagues at University of California at San
Francisco (UCSF), San Francisco General Hospital (SFGH), and the Community
Consortium are seeking participants for their study of the effects of
medicinal marijuana on the immune system, and its interaction with protease
inhibitor drugs. Many people with HIV/AIDS use medical cannabis to help
relieve drug-induced nausea and to stimulate their appetite and prevent
weight loss.

Participants taking part in the study will be hospitalized at SFGH's General
Clinical Research Center (GCRC) for 25 nights. They will be randomized
(selected by chance) to receive smoked marijuana, Marinol pills (an oral
drug that contains THC, one of the active ingredients in marijuana), or
placebo (inactive) pills for 21 days. Regular blood and urine tests will be
conducted. Participants are expected to have follow-up outpatient visits
five days and 37 days after the end of the hospital stay. Those who complete
the study will receive $1,000.

The study began in May and is slated to run for two years. However, because
the GCRC can only accommodate a few participants at a time, a continual
stream of enrollees is needed. Eleven patients have entered the study so
far, Abrams said, out of a total projected enrollment of 63.

In part because the federal government has imposed strict limitations on the
study of marijuana, there are several criteria that potential participants
must meet. They must have documented HIV infection and have been on a stable
antiretroviral treatment regimen that includes either indinavir (Crixivan)
or nelfinavir (Viracept) for at least eight weeks, with a stable viral load
for at least four weeks. Participants cannot have active opportunistic
infections or be taking other medications that affect weight gain or immune
function (for example, Megace, anabolic steroids, human growth hormone, or
interleukin-2). Women may not be pregnant.

Several study restrictions involve the use of other substances. Those who
wish to take part in the study must have used marijuana at least six times
before in their lives, but not within the 30 days prior to enrolling. In
addition, participants cannot have smoked tobacco for the previous 30 days,
be on methadone maintenance, or be dependent on alcohol or any street drugs.

The current study will focus on metabolic interactions between medicinal
marijuana or Marinol and protease inhibitors. It will also attempt to gauge
marijauna's effect on the immune system, as measured by changes in HIV viral
load and various immune markers. Abrams's team will also look at the
short-term effects of marijuana on appetite, food intake, energy
expenditure, body composition, and wasting. However, the study is not
intended to determine the effectiveness of medicinal cannabis, since it will
include too few people. "Although though the study is focused on safety,"
said Abrams, "we will still be getting a lot of information about efficacy."

The federal government demanded that a study first prove the safety of
medical marijuana before examining its effectiveness, according to Abrams.
Two earlier proposed effectiveness studies were disallowed; both the
National Institutes of Health (NIH) and the Drug Enforcement Agency refused
to allow access to government-grown cannabis, the only officially approved
source of marijuana for research purposes. The current study is the first
federally sponsored study of marijuana in people with HIV/AIDS, and is being
funded by a $1 million NIH grant.

Participation in the study is a way to help advance the body of knowledge
about medical marijuana at a time when the drug is receiving a great deal of
attention from the federal government as well as from local health
departments. People who participate, said Abrams, "are contributing to a
really pioneering project."

Those interested in the "Short-Term Effects of Cannabinoids in HIV Patients"
study can call (415) 502-5705 for further information and eligibility
requirements.

Checked-by: Rolf Ernst