The first randomized clinical trial of nabilone for the treatment of fibromyalgia pain was recently conducted at the University of Manitoba in Canada. Nabilone (pronounced NAB ill own) is a synthetic cannabinoid that mimics the main ingredient of marijuana (THC). It is marketed in the U.S., Canada, the United Kingdom and Mexico under the brand name Cesamet. Nabilone is approved by the FDA for use as an antiemetic for chemotherapy-induced nausea and vomiting that cannot be controlled by other medications.
A randomized, double-blind, placebo-controlled trial was conducted to determine whether nabilone would improve pain management and quality of life for fibromyalgia patients. Forty FM patients were divided into two groups. Over a four-week period, one group received nabilone, titrated up from 0.5 mg at bedtime to 1 mg twice a day, and the other group received a corresponding placebo. Subjects in both groups were allowed to continue taking their regular medications.
Subjects were assessed after two weeks and again after four weeks using the visual analog scale (VAS) [0 = no pain; 10 = worst pain imaginable], the number of tender points, the average tender point pain threshold, and the Fibromyalgia Impact Questionnaire (FIQ) [evaluates the impact FM is having on the subject’s functionality and quality of life]. After four weeks, the group receiving nabilone showed significant decreases in the VAS score and in the FIQ anxiety levels, but there was no significant improvement in either number of tender points or tender point pain thresholds. The control group receiving the placebo showed no significant improvement in any area.
Subjects returned after eight weeks, following a four-week washout period. At that time the outcome measures for both groups showed no significant difference from their original baseline scores, indicating that Nabilone does not have any lasting benefit when treatment is discontinued. The reported side effects of Nabilone were generally mild, and it did not seem to have any adverse interactions with the medications subjects were already taking.
Researchers reported that nabilone appeared to be a beneficial, well-tolerated treatment option for fibromyalgia patients, offering significant benefits in pain relief and functional improvement. However, since this is the first study of nabilone for FM, the duration of the study was short, and there were a limited number of participants, researchers concluded that future studies are necessary to accurately assess whether nabilone is an effective treatment for fibromyalgia.
Published On: November 08, 2007