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

NCT00381199 | Completed

• 1 other identifier: GEN#05-017
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia; Sleep Initiation and Maintenance Disorders

Keywords

fibromyalgia; cannabinoid; chronic pain; sleep; insomnia; diffuse widespread pain; antidepressant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Interventions

Amitriptyline Hydrochloride DRUG

Nabilone DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Centre, Pain Centre

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Fibromyalgia; Sleep Initiation and Maintenance Disorders; Chronic Pain

Interventions

Amitriptyline; nabilone

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Mark A Ware

  McGill University Health Centre, Pain Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 25, 2006
• First Posted: September 27, 2006
• Study Start: April 1, 2006
• Study Completion: March 1, 2007
• Last Updated: May 21, 2007

Record last verified: 2007-05

Locations

CA (1)