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
|
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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 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 |

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Drug: Nabilone
- Visual Analogue Scale for Pain [ Time Frame: Baseline, 2, 4 and 6 weeks ]
- Depression Anxiety and Stress Scale [ Time Frame: Baseline, 2, 4 and 6 weeks ]
- Groningen Sleep Quality Scale [ Time Frame: Baseline, 2, 4 and 6 weeks ]
- SF-36 [ Time Frame: Baseline, 2, 4 and 6 weeks ]
- Frequency of phantom limb pain [ Time Frame: Baseline, 2, 4 and 6 weeks ]
- Daily prosthetic wearing time [ Time Frame: Baseline, 2, 4 and 6 weeks ]

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Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
Canada, Manitoba | |
Rehabilitation Hospital | |
Winnipeg, Manitoba, Canada, R3A 1M4 |
Principal Investigator: | Ryan Q Skrabek, MD, FRCPC | University of Manitoba |
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 |