A Trial Assessing the Effect of 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Visual Analogue Scale Pain Scores [ Time Frame: Baseline, then at week 2, 4 and 8 ] [ Designated as safety issue: No ]Patient is asked to mark their pain from 0 to 10, with 0 = no pain, and 10 = worst pain imaginable
- Number of Tender Points [ Time Frame: At baseline, then at the week 2, 4 and 8 visits ] [ Designated as safety issue: No ]Physician examines by digital palpation for pain at each of the 18 characteristic tender points for fibromyalgia. The number of tender points where pain is reported is recorded
- Average Pain Threshold [ Time Frame: At baseline, then at the 2, 4 and 8 week visits ] [ Designated as safety issue: No ]Patients are examined for pain at the 18 characteristic tender points. The results of all the sites are added and divided by 18 to give an average pain threshold
- Fibromyalgia Impact Questionaire [ Time Frame: At baseline, then again at weeks 2, 4 and 8. ] [ Designated as safety issue: No ]Self-administered questionnaire that evaluates physical function, work status, depression anxiety, sleep, pain, stiffness, fatigue and well-being.
|Study Start Date:||April 2006|
|Study Completion Date:||March 2007|
|Primary Completion Date:||February 2007 (Final data collection date for primary outcome measure)|
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.
|Winnipeg, Manitoba, Canada, R3A 1M4|
|Principal Investigator:||Lena Galimova, MD||The Royal College of Physicians and Surgeons of Canada|
|Study Chair:||Ryan Skrabek, MD||University of Manitoba|