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

This study has been completed.
Sponsor:
Collaborator:
Valeant Canada Limited
Information provided by (Responsible Party):
Dr. Lena Galimova, Winnipeg Regional Health Authority
ClinicalTrials.gov Identifier:
NCT00272207
First received: January 3, 2006
Last updated: August 24, 2011
Last verified: August 2011
  Purpose

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 Intervention Phase
Fibromyalgia
Drug: Nabilone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Winnipeg Regional Health Authority:

Primary Outcome Measures:
  • Visual Analogue Scale Pain Scores [ Time Frame: Baseline, then at week 2, 4 and 8 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    Self-administered questionnaire that evaluates physical function, work status, depression anxiety, sleep, pain, stiffness, fatigue and well-being.


Enrollment: 40
Study Start Date: April 2006
Study Completion Date: March 2007
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00272207

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

No publications provided

Responsible Party: Dr. Lena Galimova, MD, FRCPC, Winnipeg Regional Health Authority
ClinicalTrials.gov Identifier: NCT00272207     History of Changes
Other Study ID Numbers: WPG2005#1974
Study First Received: January 3, 2006
Last Updated: August 24, 2011
Health Authority: Canada: Health Canada

Keywords provided by 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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 18, 2014