A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia
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| ClinicalTrials.gov Identifier: NCT00272207 |
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Recruitment Status :
Completed
First Posted : January 4, 2006
Last Update Posted : August 25, 2011
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Fibromyalgia | Drug: Nabilone | Phase 2 |
Fibromyalgia is a disease of unknown cause. People with fibromyalgia experience diffuse body pain, fatigue, sleep disturbance, and a generalized stiffness and swollen feeling. Fibromyalgia affects 2-6% of the general population, affecting females more commonly than males. Symptoms usually start between 20 and 55 years of age.
No medical treatment has been specifically approved for the management of fibromyalgia, however, there is strong evidence that some antidepressants, exercise, and patient education are effective in reducing the pain experienced by fibromyalgia patients. A recent study of four patients has suggested the possible benefit of Nabilone, a synthetic cannabinoid, in the treatment of fibromyalgia, however more studies are needed.
Marijuana is the common name for cannabis. Nabilone (brand name, CESAMET®), is a synthetic cannabinoid (form of cannabis). Cannabinoid receptors exist naturally in the human body and respond to naturally occurring cannabinoids produced by the body, as well as marijuana and synthetic cannabinoids like Nabilone.
In Canada, Nabilone is approved for the treatment and management of severe nausea and vomiting associated with cancer chemotherapy and may be prescribed by physicians.
Research has shown that activating the cannabinoid receptors also has an effect on reducing acute and chronic pain.
Our hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the pain experienced by patients with fibromyalgia and improve quality of life, compared to the placebo controlled group. This will be evident by finding significant differences in Visual Analogue Scale pain scores, number of tender points, average pain threshold, and scores on the Fibromyalgia Impact Questionaire.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Randomized Double-blinded Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Fibromyalgia |
| Study Start Date : | April 2006 |
| Actual Primary Completion Date : | February 2007 |
| Actual Study Completion Date : | March 2007 |
- Drug: Nabilone
Oral nabilone, 0.5 mg x7 days, increased to 0.5 mg t.i.d x 2 weeks if patient tolerates, then increase if patient tolerating to 0.5 in am and 1.0 mg at hs x 1 week, then if patient tolerating, increase to 1.0 mg b.i.d x 1 week.Other Name: Cesamet
- Visual Analogue Scale Pain Scores [ Time Frame: Baseline, then at week 2, 4 and 8 ]Patient is asked to mark their pain from 0 to 10, with 0 = no pain, and 10 = worst pain imaginable
- Number of Tender Points [ Time Frame: At baseline, then at the week 2, 4 and 8 visits ]Physician examines by digital palpation for pain at each of the 18 characteristic tender points for fibromyalgia. The number of tender points where pain is reported is recorded
- Average Pain Threshold [ Time Frame: At baseline, then at the 2, 4 and 8 week visits ]Patients are examined for pain at the 18 characteristic tender points. The results of all the sites are added and divided by 18 to give an average pain threshold
- Fibromyalgia Impact Questionaire [ Time Frame: At baseline, then again at weeks 2, 4 and 8. ]Self-administered questionnaire that evaluates physical function, work status, depression anxiety, sleep, pain, stiffness, fatigue and well-being.
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The patient meets The American College of Rheumatology (1990) criteria for the classification of fibromyalgia. [5]
- 18-70 years old.
- Any gender.
- The patient has not received benefit from a tricyclic antidepressant, muscle relaxant, acetaminophen or non-steroidal anti-inflammatories for management of their pain.
- No previous use of oral cannabinoids for pain management.
Exclusion Criteria:
- The patient's pain is better explained by a diagnosis other then fibromyalgia.
- Abnormalities on routine baseline blood work including electrolytes, urea and creatinine, a complete blood count, and liver function tests (AST ALT GGT, Alk Phos, and LDH). Normal tests taken within 3 months prior to the study will be accepted if there is no history of acute illness since the time the blood was drawn.
- Heart disease. (Cannabinoids can reduce heart rate and blood pressure) Patients with heart disease will be excluded based on a history of angina, MI or CHF as well as a clinical exam.
- Schizophrenia or other Psychotic disorder
- Severe liver dysfunction. (Patients will be excluded if there is an elevation of any of the baseline liver enzymes)
- History of untreated non-psychotic emotional disorders.
- Cognitive impairment.
- Major illness in another body area.
- Pregnancy.
- Nursing mothers.
- Patients less than 18 years old.
- History of drug dependency.
- A known sensitivity to marijuana or other cannabinoid agents
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 ClinicalTrials.gov identifier (NCT number): NCT00272207
| Canada, Manitoba | |
| Rehabilitation Hospital | |
| Winnipeg, Manitoba, Canada, R3A 1M4 | |
| Principal Investigator: | Lena Galimova, MD | The Royal College of Physicians and Surgeons of Canada | |
| Study Chair: | Ryan Skrabek, MD | University of Manitoba |
| Responsible Party: | Dr. Lena Galimova, MD, FRCPC, Winnipeg Regional Health Authority |
| ClinicalTrials.gov Identifier: | NCT00272207 History of Changes |
| Other Study ID Numbers: |
WPG2005#1974 |
| First Posted: | January 4, 2006 Key Record Dates |
| Last Update Posted: | August 25, 2011 |
| Last Verified: | August 2011 |
Keywords provided by Dr. Lena Galimova, Winnipeg Regional Health Authority:
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Fibromyalgia Cannabinoids Nabilone Cesamet Pain |
Additional relevant MeSH terms:
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Fibromyalgia Myofascial Pain Syndromes Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Nabilone Dronabinol Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents |
Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Hallucinogens Analgesics, Non-Narcotic Analgesics Sensory System Agents Cannabinoid Receptor Agonists Cannabinoid Receptor Modulators Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |