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Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia
This study has been completed.
First Received: September 25, 2006   Last Updated: May 16, 2007   History of Changes
Sponsor: McGill University Health Center
Information provided by: McGill University Health Center
ClinicalTrials.gov Identifier: NCT00381199
  Purpose

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.


Condition Intervention
Fibromyalgia
Sleep Initiation and Maintenance Disorders
Drug: Amitriptyline Hydrochloride
Drug: Nabilone

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Efficacy Study
Official Title: Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome 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 Outcome 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 ]

Enrollment: 32
Study Start Date: April 2006
Study Completion Date: March 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00381199

Locations
Canada, Quebec
McGill University Health Centre, Pain Centre
Montreal, Quebec, Canada, H3G 1A4
Sponsors and Collaborators
McGill University Health Center
Investigators
Principal Investigator: Mark A Ware McGill University Health Centre, Pain Centre
  More Information

No publications provided

Study ID Numbers: GEN#05-017
Study First Received: September 25, 2006
Last Updated: May 16, 2007
ClinicalTrials.gov Identifier: NCT00381199     History of Changes
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
fibromyalgia
cannabinoid
chronic pain
sleep
insomnia
diffuse widespread pain
antidepressant

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Sleep Disorders
Nabilone
Sleep Disorders, Intrinsic
Neuromuscular Diseases
Musculoskeletal Diseases
Mental Disorders
Sensory System Agents
Therapeutic Uses
Analgesics
Antidepressive Agents
Tranquilizing Agents
Myofascial Pain Syndromes
Fibromyalgia
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Depressants
Dyssomnias
Rheumatic Diseases
Pharmacologic Actions
Antidepressive Agents, Tricyclic
Muscular Diseases

ClinicalTrials.gov processed this record on February 09, 2010