Clinical trial NCT00699634: Nabilone for the Treatment of Phantom Limb Pain
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Phantom Limb Pain
Neuropathic Pain
Keywords: Neuropathic
Pain
Phantom
Limb
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Valeant Canada Limited
First posted: 2008-06-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.
* History of drug dependency.
* A known sensitivity to marijuana or other cannabinoid agents

Primary outcomes:
measure: Visual Analogue Scale for Pain
timeFrame: Baseline, 2, 4 and 6 weeks
Secondary outcomes:
measure: Depression Anxiety and Stress Scale
timeFrame: Baseline, 2, 4 and 6 weeks
measure: Groningen Sleep Quality Scale
timeFrame: Baseline, 2, 4 and 6 weeks
measure: SF-36
timeFrame: Baseline, 2, 4 and 6 weeks
measure: Frequency of phantom limb pain
timeFrame: Baseline, 2, 4 and 6 weeks
measure: Daily prosthetic wearing time
timeFrame: Baseline, 2, 4 and 6 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Rehabilitation Hospital
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Ryan Q Skrabek, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: