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| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Quebec | |
| McGill University Health Centre, Pain Centre | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| Principal Investigator: | Mark A Ware | McGill University Health Centre, Pain Centre |
More Information
| 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 |
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fibromyalgia cannabinoid chronic pain sleep |
insomnia diffuse widespread pain antidepressant |
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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 |