Status:
COMPLETED
Nabilone for the Treatment of Phantom Limb Pain
Lead Sponsor:
University of Manitoba
Collaborating Sponsors:
Valeant Canada Limited
Conditions:
Phantom Limb Pain
Neuropathic Pain
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00699634
Start Date
January 1 2009
End Date
April 1 2011
Last Update
April 29 2011
Active Locations (1)
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1
Rehabilitation Hospital
Winnipeg, Manitoba, Canada, R3A 1M4