Nabilone for the Treatment of Phantom Limb Pain

Neuropathic Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00699634
• Other study ID #: 1975
• Secondary ID: REB: B2007:129Im
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2008
• Last updated: April 28, 2011
• Start date: January 2009
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: University of Manitoba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Health Canada: Clinical Trials and Special Access ProgramCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuropathic Pain
• Phantom Limb
• Phantom Limb Pain

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Canada	Rehabilitation Hospital	Winnipeg	Manitoba

Sponsors (2)

Lead Sponsor	Collaborator
University of Manitoba	Valeant Canada Limited

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale for Pain		Baseline, 2, 4 and 6 weeks	No
Secondary	Depression Anxiety and Stress Scale		Baseline, 2, 4 and 6 weeks	No
Secondary	Groningen Sleep Quality Scale		Baseline, 2, 4 and 6 weeks	No
Secondary	SF-36		Baseline, 2, 4 and 6 weeks	No
Secondary	Frequency of phantom limb pain		Baseline, 2, 4 and 6 weeks	No
Secondary	Daily prosthetic wearing time		Baseline, 2, 4 and 6 weeks	No