- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00699634
Nabilone for the Treatment of Phantom Limb Pain
A Randomized Double-blind Placebo Controlled Trial Assessing the Effect of the Oral Cannabinoid Nabilone on Pain and Quality of Life in Patients With Phantom Limb Pain
The purpose of this proposed study is to conduct a randomized double-blind placebo controlled trial assessing the benefit of nabilone in pain management and improvement of quality of life in patients with phantom limb pain.
Our Hypothesis is that the synthetic cannabinoid Nabilone will significantly reduce the phantom limb pain 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, frequency of phantom pain episodes, the Depression, Anxiety and Stress Scale, and the Groningen Sleep Quality Scale and daily prosthetic wearing time.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3A 1M4
- Rehabilitation Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- The patient has been diagnosed with phantom limb pain by a Rehabilitation Medicine Specialist.
- 18-70 years old.
- Any gender.
- The patient has not had resolution of their phantom limb pain with other treatments, such as a tricyclic antidepressant, or anticonvulsant medication.
- No previous use of oral cannabinoids for pain management.
Exclusion Criteria:
- The patient's pain is better explained by a treatable cause of stump pain, such as neuroma or bony overgrowth.
- Gross 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) that are twice the limit of normal. 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 symptomatic angina, MI or CHF as well as a clinical exam.
- Schizophrenia or other Psychotic disorder
- Severe liver dysfunction.
- History of untreated non-psychotic emotional disorders.
- Cognitive impairment.
- Major illness in another body area.
- Pregnancy.
- Nursing mothers.
- History of drug dependency.
- A known sensitivity to marijuana or other cannabinoid agents
Study Plan
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 |
Time Frame |
---|---|
Visual Analogue Scale for Pain
Time Frame: Baseline, 2, 4 and 6 weeks
|
Baseline, 2, 4 and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Depression Anxiety and Stress Scale
Time Frame: Baseline, 2, 4 and 6 weeks
|
Baseline, 2, 4 and 6 weeks
|
Groningen Sleep Quality Scale
Time Frame: Baseline, 2, 4 and 6 weeks
|
Baseline, 2, 4 and 6 weeks
|
SF-36
Time Frame: Baseline, 2, 4 and 6 weeks
|
Baseline, 2, 4 and 6 weeks
|
Frequency of phantom limb pain
Time Frame: Baseline, 2, 4 and 6 weeks
|
Baseline, 2, 4 and 6 weeks
|
Daily prosthetic wearing time
Time Frame: Baseline, 2, 4 and 6 weeks
|
Baseline, 2, 4 and 6 weeks
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ryan Q Skrabek, MD, FRCPC, University of Manitoba
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neuromuscular Diseases
- Peripheral Nervous System Diseases
- Perceptual Disorders
- Pain, Postoperative
- Neuralgia
- Phantom Limb
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Nabilone
Other Study ID Numbers
- 1975
- REB: B2007:129
- Impact: RI07:119
- Health Canada: 116697
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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