A Trial Assessing the Effect of Nabilone on Pain & Quality of Life in

Status Completed

Clinical Trial 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00272207
Study type	Interventional
Source	Winnipeg Regional Health Authority
Contact
Status	Completed
Phase	Phase 2
Start date	April 2006
Completion date	March 2007

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05659862` - Digitally Assisted Behavioral Physical Activity Intervention in Fibromyalgia	N/A
Recruiting	`NCT03207828` - Testing Interventions for Patients With Fibromyalgia and Depression	N/A
Completed	`NCT03042728` - Impact of Inclusion of a Therapy Dog Visit as Part of the Fibromyalgia Treatment Program	N/A
Recruiting	`NCT06097091` - Effects and Mechanisms of Pain Neuroscience Education in Patients With Fibromyalgia	N/A
Recruiting	`NCT04554784` - Effectiveness of Bowen Therapy for Pain Management in Patients With Fibromyalgia	N/A
Completed	`NCT03300635` - Metabolism, Muscle Function and Psychological Factors in Fibromyalgia	N/A
Recruiting	`NCT06166563` - Exercise, Irritable Bowel Syndrome and Fibromyalgia	N/A
Completed	`NCT03227952` - Sensory Stimulation in Fibromyalgia	N/A
Completed	`NCT03166995` - Postural Exercises in Women With Fibromyalgia	N/A
Recruiting	`NCT06237595` - Vagus Nerve Stimulation in Fibromyalgia	N/A
Completed	`NCT01888640` - Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)	N/A
Completed	`NCT03641495` - Pain Education and Therapeutic Exercise for Fibromyalgia	N/A
Recruiting	`NCT05581628` - FREQUENCY OF FIBROMYALGIA IN PATIENTS WITH CELIAC DISEASE
Active, not recruiting	`NCT05128162` - Open-label Study to Assess the Safety and Efficacy of Psilocybin With Psychotherapy in Adult Participants With Fibromyalgia	Phase 2
Completed	`NCT04674878` - Comparison of Muscle Energy Techniques and Breathing Exercises for Functional Improvement in Fibromyalgia	N/A
Active, not recruiting	`NCT04084795` - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia	N/A
Completed	`NCT03129906` - Impact of the Restriction of Sources of Gluten in Fibromyalgia Patients	N/A
Completed	`NCT05058911` - Exposure-based Cognitive Behavior Therapy vs Traditional Cognitive Behavior Therapy for Fibromyalgia	N/A
Recruiting	`NCT04571528` - Effectiveness of VIRTUAL FIBROWALK STUDY	N/A
Recruiting	`NCT04571853` - New Educational Tool for FM	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms