Fibromyalgia, Sleep Initiation and Maintenance Disorders
Conditions
Keywords
fibromyalgia, cannabinoid, chronic pain, sleep, insomnia, diffuse widespread pain, antidepressant
Brief summary
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.
Interventions
DRUGNabilone
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥18 years; * A diagnosis of fibromyalgia according to the American College of Rheumatology classification criteria (Wolfe F, Smythe HA, et al 1990); * Suffering from self-reported disturbed sleep; * Negative urine screen for cannabinoids; * Women of childbearing potential must agree to use adequate contraception during study and for 3 months after study; * Ability to attend research centre every second week for approximately seven to nine weeks and be able to be contacted by telephone during the study period; * Stable drug regimen for 1 month prior to randomization; * Normal liver (AST \<3x normal) and renal function (serum creatinine \<133µmol/L); * Haematocrit \>38%; * Negative serum bHCG; * Proficient in English or French; * Willing and able to give written informed consent; * Ability to follow study protocol (cognitive and situational).
Exclusion criteria
* Patients currently using cannabis or cannabinoid or tricyclic antidepressants (TCA) and who are unable to undergo a 2 week washout period before entering the study; * Pain due to cancer; * Unstable cardiac disease such as cardiac arrhythmias, cardiac failure, ischaemic heart disease and/or hypertension on clinical history and examination; * History of psychotic disorder or schizophrenia; * Known hypersensitivity to cannabinoids, amitriptyline, or related tricyclic antidepressants; * Currently taking or unable to stop taking monoamine oxidase inhibitors (a two-week washout period is necessary for subjects taking MAOIs); * History of seizures/epilepsy; * Diagnosis of glaucoma; * Urinary retention; * Pregnancy and/or breast-feeding; * Participation in other clinical trial in the 30 days prior to randomization; * A recent manic episode (within the past year); * Current suicidal ideation or history of suicide attempts
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of sleep assessed using the Leeds Sleep Evaluation Questionnaire and the Insomnia Severity Index | Day 1, 15, 29 and 43 and given to the patient to complete every second day while taking the study medication |
Secondary
| Measure | Time frame |
|---|---|
| Pain Intensity using the VAS (visual analogue scale) | Days 1, 15, 29 and 43 |
| Pain Quality using the McGill Pain Questionnaire | Days 1, 15, 29 and 43 |
| Mood using the Profile of Mood States (POMS) Questionnaire | Days 1, 15, 29 and 43 |
| Quality of Life using the Fibromyalgia Impact Questionnaire (FIQ) | Days 1, 15, 29 and 43 |
Countries
Canada
Outcome results
None listed