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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00381199
Recruitment Status : Completed
First Posted : September 27, 2006
Last Update Posted : May 21, 2007
Information provided by:
McGill University Health Center

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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Sleep Initiation and Maintenance Disorders Drug: Amitriptyline Hydrochloride Drug: Nabilone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Nabilone Versus Amitriptyline in Improving Quality of Sleep in Patients With Fibromyalgia
Study Start Date : April 2006
Actual Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Primary Outcome Measures :
  1. 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 :
  1. Pain Intensity using the VAS (visual analogue scale) [ Time Frame: Days 1, 15, 29 and 43 ]
  2. Pain Quality using the McGill Pain Questionnaire [ Time Frame: Days 1, 15, 29 and 43 ]
  3. Mood using the Profile of Mood States (POMS) Questionnaire [ Time Frame: Days 1, 15, 29 and 43 ]
  4. Quality of Life using the Fibromyalgia Impact Questionnaire (FIQ) [ Time Frame: Days 1, 15, 29 and 43 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00381199

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

Layout table for additonal information Identifier: NCT00381199     History of Changes
Other Study ID Numbers: GEN#05-017
First Posted: September 27, 2006    Key Record Dates
Last Update Posted: May 21, 2007
Last Verified: May 2007

Keywords provided by McGill University Health Center:
chronic pain
diffuse widespread pain

Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Sleep Initiation and Maintenance Disorders
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Mental Disorders
Amitriptyline, perphenazine drug combination
Antidepressive Agents, Tricyclic
Antidepressive Agents
Psychotropic Drugs
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents