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Nabilone for the Treatment of Phantom Limb Pain

Primary Purpose

Phantom Limb Pain, Neuropathic Pain

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Nabilone
Sponsored by
University of Manitoba
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain focused on measuring Neuropathic, Pain, Phantom, Limb

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Rehabilitation Hospital

Outcomes

Primary Outcome Measures

Visual Analogue Scale for Pain

Secondary Outcome Measures

Depression Anxiety and Stress Scale
Groningen Sleep Quality Scale
SF-36
Frequency of phantom limb pain
Daily prosthetic wearing time

Full Information

First Posted
June 17, 2008
Last Updated
April 28, 2011
Sponsor
University of Manitoba
Collaborators
Valeant Canada Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00699634
Brief Title
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

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Manitoba
Collaborators
Valeant Canada Limited

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain, Neuropathic Pain
Keywords
Neuropathic, Pain, Phantom, Limb

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Nabilone
Other Intervention Name(s)
Cesemet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Visual Analogue Scale for Pain
Time Frame
Baseline, 2, 4 and 6 weeks
Secondary Outcome Measure Information:
Title
Depression Anxiety and Stress Scale
Time Frame
Baseline, 2, 4 and 6 weeks
Title
Groningen Sleep Quality Scale
Time Frame
Baseline, 2, 4 and 6 weeks
Title
SF-36
Time Frame
Baseline, 2, 4 and 6 weeks
Title
Frequency of phantom limb pain
Time Frame
Baseline, 2, 4 and 6 weeks
Title
Daily prosthetic wearing time
Time Frame
Baseline, 2, 4 and 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Q Skrabek, MD, FRCPC
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1M4
Country
Canada

12. IPD Sharing Statement

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Nabilone for the Treatment of Phantom Limb Pain

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