A Trial Assessing the Effect of Nabilone on Pain and Quality of Life in Patients With Fibromyalgia

• Status: Completed
• Trial end date: 2007-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether or not the drug Nabilone significantly reduces pain and improves quality of life in patients with fibromyalgia.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Winnipeg Regional Health Authority
• Collaborator: Valeant Canada Limited
• Treatments: Dronabinol; Nabilone

Criteria

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