Official Title: “Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia”

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

Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Amitriptyline Hydrochloride
• Drug: Nabilone

Primary Measures

• 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
    

Secondary Measures

• 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
    

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: McGill University Health Center

Overall Clinical Trial Officials and Contacts

Mark A Ware Principal Investigator McGill University Health Centre, Pain Centre  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00381199

Study ID Number: GEN#05-017

ClinicalTrials.gov Identifier: NCT00381199

Health Authority: Canada: Health Canada