ST. MIKE'S STUDY PROBES ROLE OF MEDICAL POT

First Canadian trial will focus on HIV/AIDS patients

(CP) - Will marijuana-induced munchies help people with HIV and AIDS combat
nausea and avoid the weight-loss that the disease brings on? Researchers in
Toronto are hoping to find out.

Canada's first government-sponsored trial of medicinal marijuana in
HIV/AIDS officially started on Wednesday, led by researchers from St.
Michael's Hospital and the Community Research Initiative of Toronto.

"I think the time is right to look at this," said principal investigator
Dr. Kevin Gough, medical director of HIV services at the hospital.

"Let's find out what role, if any, that smoked cannabis has in, not only
HIV and AIDS, but other medical illnesses as well."

Advocates of medicinal marijuana believe the drug can be useful for a wide
range of conditions. Anecdotal evidence suggests it helps in pain control,
curbs nausea brought on by chemotherapy or HIV/AIDS drugs, and stimulates
the appetite of people who have lost interest in eating as a result of
their conditions or medications.

But anecdotal evidence doesn't cut it when you are asking a government to
allow large numbers of ill people to buy and smoke what is still an illegal
substance.

So Health Canada has authorized research to gather clinical evidence that
may have implications for Canadian policy, and that will likely be
scrutinized by governments outside Canada as well.

The current study is a pilot to gather information that will be used to
design a larger, multi-centre clinical trial. The pilot phase, involving 32
participants with HIV/AIDS, is expected to last about a year.

All participants will have smoked marijuana before. Because there is little
consensus on any risks associated with marijuana use, researchers can't
ethically ask people to take the drug for the first time for a study.

But only people who haven't used the drug in the previous 30 days will be
eligible to take part. That's to ensure there are no lingering effects of
non-study marijuana in their systems.

Over a two-month period, each participant will be given three supplies of
varying strengths of marijuana plus a placebo. They will be asked to use
each for a period of one week and will not be informed which is which.

Throughout the study they will keep a diary detailing how much they smoked,
how they felt, and how much and what they ate.

After using one strength for a week, they will be asked to go a week
without smoking marijuana, to cleanse the drug from their systems.

Participants will be barred from using non-study marijuana during the trial
and will be tested to ensure they are honouring that rule. Street marijuana
contains compounds not found in study-grade marijuana, Gough explained.

Although Canada is in the process of developing its own supply of
study-grade marijuana, the crop - being grown in an underground facility in
Manitoba - isn't ready for use. The marijuana for this study comes from the
U.S. National Institute of Drug Abuse, currently the only producer of
research-grade marijuana in North America.

Police officials have been informed of the trial. Participants will be told
they can carry with them small quantities of the study marijuana, but they
must also carry a letter explaining their role in the trial.

Study organizers don't expect to have any trouble filling the 32 slots.
Many people in the HIV/AIDS community regularly use marijuana, said Derek
Thaczuk, spokesperson for the Community Research Initiative.

"Not everybody cares that there's a lack of scientific evidence," Thaczuk
said. "So a lot of people with HIV are using marijuana to reduce their
levels of nausea and to increase their food intake to fight weight loss,
which can be an extremely serious condition for people with HIV."

Thaczuk said he's delighted that the study, which has been several years in
the making, is finally underway.

"No matter what the issues connected with medical marijuana, it comes back
to the fact that we need valid, rigorous scientific data, and that's what
we're going to produce."

Health Canada's program to investigate marijuana's potential as a medicinal
substance was started under former health minister Allan Rock. Some have
speculated the current minister, Anne McLellan, is less enthusiastic about
the program than her predecessor, but she insists that is not the case.

"The minister remains committed to ensuring that we understand the benefits
and risks associated with marijuana use for medicinal purposes," her
spokesperson, Farah Mohamed, said Wednesday.