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

University of Manitoba1 site in 1 country50 target enrollmentJanuary 2009

ConditionsPhantom Limb Pain Neuropathic Pain

DrugsNabilone

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Phantom Limb Pain
Sponsor: University of Manitoba
Enrollment: 50
Locations: 1
Primary Endpoint: Visual Analogue Scale for Pain
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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 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.

Registry

clinicaltrials.gov

Start Date

January 2009

End Date

April 2011

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Manitoba

Eligibility Criteria

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.