Nabilone for the Treatment of Phantom Limb Pain

This study has been completed.
Sponsor:
Collaborator:
Valeant Canada Limited
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00699634
First received: June 17, 2008
Last updated: April 28, 2011
Last verified: April 2011

June 17, 2008
April 28, 2011
January 2009
February 2011   (final data collection date for primary outcome measure)
Visual Analogue Scale for Pain [ Time Frame: Baseline, 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00699634 on ClinicalTrials.gov Archive Site
  • Depression Anxiety and Stress Scale [ Time Frame: Baseline, 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
  • Groningen Sleep Quality Scale [ Time Frame: Baseline, 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
  • SF-36 [ Time Frame: Baseline, 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
  • Frequency of phantom limb pain [ Time Frame: Baseline, 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
  • Daily prosthetic wearing time [ Time Frame: Baseline, 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Nabilone for the Treatment of Phantom Limb Pain
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Phantom Limb Pain
  • Neuropathic Pain
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.
Other Name: Cesemet
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
April 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00699634
1975, REB: B2007:129, Impact: RI07:119, Health Canada: 116697
Yes
Dr. Ryan Quinlan Skrabek, University of Manitoba
University of Manitoba
Valeant Canada Limited
Principal Investigator: Ryan Q Skrabek, MD, FRCPC University of Manitoba
University of Manitoba
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP