The Bay Area Reporter - August 31, 2000
Bob Roehr

Cannabinoids, including THC, are the active chemical compounds in marijuana. Receptors or docking stations for cannabinoids are found on cells in the central nervous system and brain. More recently they have been identified on cells in the immune system. The short-term mating of cannabinoid and receptor produces the buzz or high of marijuana as well as the therapeutic effects ascribed to the natural product. It also has led some to say that marijuana is dangerous.

The foundation of Abrams's trial at the University of California at San Francisco was a safety study to see if there was any harmful interaction between marijuana and protease inhibitors when used together. The liver metabolizes both through the same pathway, the P-450 system. Another natural product, St. John's wort, which is metabolized the same way, has been found to clear some HIV and other drugs from the body faster than usual, so the potential for harmful interaction was there.

The 67 patients in the trial had stable HIV disease and were on a regimen that contained a protease inhibitor. The 25-day trial required that they be hospitalized the entire time, with no visitors, while the staff monitored every calorie that entered their body and took frequent blood samples for lab tests.

The length of the trial was not arbitrary. Abrams knew that the impact of an effective antiviral therapy is easily seen within three weeks. He reasoned that "if there was going to be an adverse or beneficial effect of the cannabinoids, that would be enough time for us to see it."

A third of the patients were asked to smoke a marijuana cigarette with 3.95 percent THC three times a day. A third were given dronabinol, sold as the prescription drug Marinol, which contains THC. The remainder were given a placebo or fake pill that looked like the Marinol capsule.

"The bottom line is that there was no statistically significant difference between the three arms of the study," said Abrams. "That means it is not likely that marijuana or dronabinol increase viral load."

But there was an ever so slight increase in viral load in the placebo arm and a slight decrease in viral load in the other two arms. Abrams theorized that "cannabinoids may be boosting the levels of protease inhibitors in the blood." An alternative explanation may be that they are modulating the immune system. Analyses of blood drug levels and immune function have not yet been completed, they may help answer the question.

AIDS wasting was a serious problem when the trial was designed several years ago. The smoking arm clearly demonstrated "the munchies" effect of marijuana as those patients increased both their caloric intake and weight. A similar but lesser effect was seen in the Marinol arm, something that had not been shown in earlier trials, though Abrams conceded that the trial was not designed with adequate size to prove these points conclusively.

Abrams wants to move on to studies that look at specific uses of marijuana. "There is some suggestion that marijuana may have an effect on pain, particularly neuropathic pain, which is not usually responsive to opioids." Neuropathy is a side effect associated with several AIDS drugs.

But nausea is his area of greatest interest. In screening participants for the trial, which required people to abstain from using marijuana for at least 30 days prior to enrolling, he found that many could not do it because they already were using marijuana to control nausea associated with their therapy.

"People asked if I was afraid that adherence would decrease if the patients are stoned," Abrams said. "But the truth might be that smoking marijuana might make people able to take their therapy better than if they don't smoke."

The "medical grade" marijuana provided for the trial by the National Institute on Drug Abuse has a THC content of less than half of what is commonly found on the street, according to an analysis of marijuana purchased at buyer's clubs nationwide.

Abrams believes that it may be better to use more potent pot because medical users will adjust their dose downward to what is required to relieve their nausea. And that will mean "less exposure to the potential [carcinogenic] effects of smoking."

Abrams is writing up a paper on the study for publication in a medical journal. He hopes that as "the first study of marijuana in people with HIV infection, it will be widely disseminated." Another handful of papers are likely on nutritional, metabolic and other aspects of the data-intense trial.

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