Nabilone for the Treatment of Phantom Limb Pain

Sponsor

University of Manitoba (Other)

Overall Status

Completed

CT.gov ID

NCT00699634

Collaborator

Valeant Canada Limited (Industry)

Enrollment

Location

26.9

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Phantom Limb Pain Neuropathic Pain	Drug: Nabilone	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Feb 1, 2011

Actual Study Completion Date :

Apr 1, 2011

Outcome Measures

Primary Outcome Measures

Visual Analogue Scale for Pain [Baseline, 2, 4 and 6 weeks]

Secondary Outcome Measures

Depression Anxiety and Stress Scale [Baseline, 2, 4 and 6 weeks]
Groningen Sleep Quality Scale [Baseline, 2, 4 and 6 weeks]
SF-36 [Baseline, 2, 4 and 6 weeks]
Frequency of phantom limb pain [Baseline, 2, 4 and 6 weeks]
Daily prosthetic wearing time [Baseline, 2, 4 and 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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