Fibromyalgia Clinical Trial
Official title:
A Randomized Double-blinded Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Fibromyalgia
The purpose of the study is to determine whether or not the drug Nabilone significantly reduces pain and improves quality of life in patients with fibromyalgia.
Fibromyalgia is a disease of unknown cause. People with fibromyalgia experience diffuse body
pain, fatigue, sleep disturbance, and a generalized stiffness and swollen feeling.
Fibromyalgia affects 2-6% of the general population, affecting females more commonly than
males. Symptoms usually start between 20 and 55 years of age.
No medical treatment has been specifically approved for the management of fibromyalgia,
however, there is strong evidence that some antidepressants, exercise, and patient education
are effective in reducing the pain experienced by fibromyalgia patients. A recent study of
four patients has suggested the possible benefit of Nabilone, a synthetic cannabinoid, in
the treatment of fibromyalgia, however more studies are needed.
Marijuana is the common name for cannabis. Nabilone (brand name, CESAMET®), is a synthetic
cannabinoid (form of cannabis). Cannabinoid receptors exist naturally in the human body and
respond to naturally occurring cannabinoids produced by the body, as well as marijuana and
synthetic cannabinoids like Nabilone.
In Canada, Nabilone is approved for the treatment and management of severe nausea and
vomiting associated with cancer chemotherapy and may be prescribed by physicians.
Research has shown that activating the cannabinoid receptors also has an effect on reducing
acute and chronic pain.
Our hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the pain
experienced by patients with fibromyalgia and improve quality of life, compared to the
placebo controlled group. This will be evident by finding significant differences in Visual
Analogue Scale pain scores, number of tender points, average pain threshold, and scores on
the Fibromyalgia Impact Questionaire.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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