Nabilone for the Treatment of Phantom Limb Pain

April 28, 2011 updated by: University of Manitoba

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1M4
        • Rehabilitation Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Scale for Pain
Time Frame: Baseline, 2, 4 and 6 weeks
Baseline, 2, 4 and 6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression Anxiety and Stress Scale
Time Frame: Baseline, 2, 4 and 6 weeks
Baseline, 2, 4 and 6 weeks
Groningen Sleep Quality Scale
Time Frame: Baseline, 2, 4 and 6 weeks
Baseline, 2, 4 and 6 weeks
SF-36
Time Frame: Baseline, 2, 4 and 6 weeks
Baseline, 2, 4 and 6 weeks
Frequency of phantom limb pain
Time Frame: Baseline, 2, 4 and 6 weeks
Baseline, 2, 4 and 6 weeks
Daily prosthetic wearing time
Time Frame: Baseline, 2, 4 and 6 weeks
Baseline, 2, 4 and 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Valeant Canada Limited

Investigators

  • Principal Investigator: Ryan Q Skrabek, MD, FRCPC, University of Manitoba

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

June 17, 2008

First Submitted That Met QC Criteria

June 17, 2008

First Posted (Estimate)

June 18, 2008

Study Record Updates

Last Update Posted (Estimate)

April 29, 2011

Last Update Submitted That Met QC Criteria

April 28, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1975
  • REB: B2007:129
  • Impact: RI07:119
  • Health Canada: 116697

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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