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Nabilone for the Treatment of Phantom Limb Pain

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ClinicalTrials.gov Identifier: NCT00699634
Recruitment Status : Completed
First Posted : June 18, 2008
Last Update Posted : April 29, 2011
Sponsor:
Collaborator:
Valeant Canada Limited
Information provided by:
University of Manitoba

Study Description
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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.


Condition or disease Intervention/treatment Phase
Phantom Limb Pain Neuropathic Pain Drug: Nabilone Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : January 2009
Actual Primary Completion Date : February 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Nabilone
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    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

Outcome Measures
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Primary Outcome Measures :
  1. Visual Analogue Scale for Pain [ Time Frame: Baseline, 2, 4 and 6 weeks ]

Secondary Outcome Measures :
  1. Depression Anxiety and Stress Scale [ Time Frame: Baseline, 2, 4 and 6 weeks ]
  2. Groningen Sleep Quality Scale [ Time Frame: Baseline, 2, 4 and 6 weeks ]
  3. SF-36 [ Time Frame: Baseline, 2, 4 and 6 weeks ]
  4. Frequency of phantom limb pain [ Time Frame: Baseline, 2, 4 and 6 weeks ]
  5. Daily prosthetic wearing time [ Time Frame: Baseline, 2, 4 and 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699634


Locations
Canada, Manitoba
Rehabilitation Hospital
Winnipeg, Manitoba, Canada, R3A 1M4
Sponsors and Collaborators
University of Manitoba
Valeant Canada Limited
Investigators
Principal Investigator: Ryan Q Skrabek, MD, FRCPC University of Manitoba
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr. Ryan Quinlan Skrabek, University of Manitoba
ClinicalTrials.gov Identifier: NCT00699634     History of Changes
Other Study ID Numbers: 1975
REB: B2007:129
Impact: RI07:119
Health Canada: 116697
First Posted: June 18, 2008    Key Record Dates
Last Update Posted: April 29, 2011
Last Verified: April 2011

Keywords provided by University of Manitoba:
Neuropathic
Pain
Phantom
Limb

Additional relevant MeSH terms:
Neuralgia
Phantom Limb
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Perceptual Disorders
Neurobehavioral Manifestations
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Nabilone
Dronabinol
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Hallucinogens
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators