Nabilone for the Treatment of Phantom Limb Pain

NCT ID: NCT00699634

Last Updated: 2011-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-04-30

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.

Conditions

Phantom Limb Pain; Neuropathic Pain

Keywords

Neuropathic; Pain; Phantom; Limb

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Interventions

Nabilone

Nabilone 0.5 mg at hs for 1 week, then 0.5 mg BID for 1 week. After a reassessment of the outcome measures, the dose is increased to 0.5 mg in the morning and 1 mg at hs for 1 week, followed by an increase to 1 mg BID in the last week of the study.

Intervention Type: DRUG

Other Intervention Names

Cesemet

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Valeant Canada Limited

INDUSTRY

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

University of Manitoba

Principal Investigators

Ryan Q Skrabek, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

Rehabilitation Hospital

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

REB: B2007:129

Identifier Type: -

Identifier Source: secondary_id

Impact: RI07:119

Identifier Type: -

Identifier Source: secondary_id

Health Canada: 116697

Identifier Type: -

Identifier Source: secondary_id

1975

Identifier Type: -

Identifier Source: org_study_id