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

August 24, 2011 updated by: Dr. Lena Galimova, Winnipeg Regional Health Authority

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

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.

Study Overview

Status

Completed

Conditions

Fibromyalgia

Intervention / Treatment

Drug: Nabilone

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 Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R3A 1M4
    - Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline, then at week 2, 4 and 8
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	At baseline, then at the week 2, 4 and 8 visits
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	At baseline, then at the 2, 4 and 8 week visits
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.	At baseline, then again at weeks 2, 4 and 8.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Winnipeg Regional Health Authority

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

February 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

January 3, 2006

First Submitted That Met QC Criteria