Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00381199
• Other study ID #: GEN#05-017
• Status: Completed
• Phase: N/A
• First received: September 25, 2006
• Last updated: May 16, 2007
• Start date: April 2006
• Est. completion date: March 2007

Study information

• Verified date: May 2007
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Amitriptyline Hydrochloride

• Nabilone

Locations

Country	Name	City	State
Canada	McGill University Health Centre, Pain Centre	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain Intensity using the VAS (visual analogue scale)		Days 1, 15, 29 and 43
Secondary	Pain Quality using the McGill Pain Questionnaire		Days 1, 15, 29 and 43
Secondary	Mood using the Profile of Mood States (POMS) Questionnaire		Days 1, 15, 29 and 43
Secondary	Quality of Life using the Fibromyalgia Impact Questionnaire (FIQ)		Days 1, 15, 29 and 43