Status:
COMPLETED
Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia
Lead Sponsor:
McGill University Health Centre/Research Institute of the McGill University Health Centre
Conditions:
Fibromyalgia
Sleep Initiation and Maintenance Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00381199
Start Date
April 1 2006
End Date
March 1 2007
Last Update
May 21 2007
Active Locations (1)
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1
McGill University Health Centre, Pain Centre
Montreal, Quebec, Canada, H3G 1A4