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

• ClinicalTrials.gov Identifier: NCT00272207
• Recruitment Status: Completed
• First Posted: January 4, 2006
• Last Update Posted: August 25, 2011
• Sponsor: Winnipeg Regional Health Authority
• Collaborator: Valeant Canada Limited
• Information provided by (Responsible Party): Dr. Lena Galimova, Winnipeg Regional Health Authority

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia	Drug: Nabilone	Phase 2

Detailed Description:

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 Design

• 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

Arms and Interventions

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

1. 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
2. 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
3. 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
4. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Canada, Manitoba

Rehabilitation Hospital

Winnipeg, Manitoba, Canada, R3A 1M4

Sponsors and Collaborators

Winnipeg Regional Health Authority

Valeant Canada Limited

Investigators

• Principal Investigator: Lena Galimova, MD; The Royal College of Physicians and Surgeons of Canada
• Study Chair: Ryan Skrabek, MD; University of Manitoba

More Information

• Responsible Party: Dr. Lena Galimova, MD, FRCPC, Winnipeg Regional Health Authority
• ClinicalTrials.gov Identifier: NCT00272207
• Other Study ID Numbers: WPG2005#1974
• First Posted: January 4, 2006
• Last Update Posted: August 25, 2011
• Last Verified: August 2011

Keywords provided by Dr. Lena Galimova, Winnipeg Regional Health Authority:

Fibromyalgia; Cannabinoids; Nabilone; Cesamet; Pain

Additional relevant MeSH terms:

Fibromyalgia; Myofascial Pain Syndromes; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Nabilone; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Anti-Anxiety Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs