OTTAWA PROBES MARIJUANA'S EFFECT ON PAIN

First Clinical Trial to Follow 32 Patients over Eight Weeks

The federal government is putting up $840,000 for Canada's first clinical
study into whether marijuana use can help ease pain.

The Community Research Initiative of Toronto and St. Michael's Hospital in
Toronto are to begin evaluating the therapeutic effects of smoked cannabis
in HIV/AIDS.

In the clinical trial, 32 patients will be closely examined over eight
weeks to test the safety of short-term exposure to different strengths of
cannabis, and how cannabis interacts with HIV medications. The analysis
will also include the effect of smoked marijuana on nausea, pain, mood and
neuro-cognitive function.

The results of the study will help determine the design of a larger,
multi-centre, clinical trial across the country. It is also important
because Anne McLellan, the federal Health Minister, has said she will not
proceed with medicinal legalization without clinical trials looking at the
plant's effectiveness.

"There is so little good concrete scientific data about the potential
benefits or effects of smoked cannabis in a number of illnesses, including
HIV and AIDS," said Kevin Gough, an infectious diseases specialist who will
act as the study's principal investigator.

"HIV itself, the disease, and the medications we use to treat it, produce a
number of side effects, including loss of appetite, nausea, and pain. Other
diseases like cancer and multiple sclerosis can also lead to similar
symptoms that might benefit from smoked cannabis, but the studies aren't there.

"This is the first trial in Canada to be looking at cannabis in any medical
context," added Dr. Gough, who is also medical director of HIV services at
St. Michael's Hospital in Toronto.

For those suffering from HIV or AIDS, loss of appetite and weight loss can
be life threatening, said Derek Thaczuk, former chairman of the board of
directors of the Community Research Initiative of Toronto, an organization
dedicated to research on HIV and AIDS.

"There is plenty of anecdotal evidence to suggest that smoking marijuana
increases people's appetite and therefore helps them gain weight," he said.
"What we're doing with this study is subjecting it to some scientific
rigour and trying to get quantitative answers to the question of 'Can
smoked cannabis help with this condition and if so, how much?' "

The marijuana has been imported from the U.S. government's National
Institutes of Drug Abuse. The organization grows its own marijuana on a
farm in Mississippi. The Canadian research team purchased 500 grams for the
research project.

Mr. Thaczuk, who chairs the Toronto research initiative's scientific
committee, said work on the study has been carried out for two years with
Health Canada, and the scientific and HIV/AIDS communities.

The study is based on a method known as a placebo-controlled crossover
design. This means all participants will receive marijuana containing four
different strengths of tetrahydrocannabinol (THC) at different times,
including a placebo. Each patient will smoke the various forms of the drug
for a week, monitoring their usage, pain level and weight. They will remain
marijuana-free for the next week, but still self-monitoring.

Although they will be smoking medicinal pot in their own homes whenever
they choose, they will undergo a battery of tests as an in-patient at a
clinic once a week.

THC is the component of cannabis known to cause the "high" people
experience. THC is also believed responsible for the drug's potential
medical benefits, such as appetite stimulation.

The study is expected to be completed within one year.

The federal government has funded another study, one in which researchers
at McGill University will research the therapeutic effects of marijuana on
neurological pain. The $235,000 project is to get underway this fall.

In August, Ms. McLellan prompted applause when she told doctors at a
meeting of the Canadian Medical Association in New Brunswick that she was
uncomfortable with people smoking pot to relieve pain and that the
government would not look at distributing medicinal marijuana before it
does clinical drug trials.

Ms. McLellan's comments appeared to contradict her predecessor Allan Rock,
who had suggested he was looking at easing up on legal access to the drug
as medicine. However, she insisted she was not backing away from the
government's plan to distribute marijuana for medicinal purposes.

Like any other drug, she said, the safety, efficacy and long-term effects
of marijuana must be studied before approval. Canadian doctors have led a
powerful lobby against prescribing pot as medicine, arguing it has not been
tested for safety or efficacy.