Most chronic pain patients with insomnia are currently not well-managed using existing medications. If found to safely improve sleep with chronic pain patients, nabilone could be added to the treatment options available in the management of fibromyalgia and associated symptoms. The principle hypothesis of this study is that nabilone at a dose of 0.5-1mg is as efficacious as amitriptyline at a dose of 10-20mg, in improving sleep quality in patients with fibromyalgia.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
32
McGill University Health Centre, Pain Centre
Montreal, Quebec, Canada
Quality of sleep assessed using the Leeds Sleep Evaluation Questionnaire and the Insomnia Severity Index
Time frame: Day 1, 15, 29 and 43 and given to the patient to complete every second day while taking the study medication
Pain Intensity using the VAS (visual analogue scale)
Time frame: Days 1, 15, 29 and 43
Pain Quality using the McGill Pain Questionnaire
Time frame: Days 1, 15, 29 and 43
Mood using the Profile of Mood States (POMS) Questionnaire
Time frame: Days 1, 15, 29 and 43
Quality of Life using the Fibromyalgia Impact Questionnaire (FIQ)
Time frame: Days 1, 15, 29 and 43
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