Nabilone for the Treatment of Phantom Limb Pain
This study has been completed.
Sponsor:
University of Manitoba
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
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Phantom Limb Pain Neuropathic Pain |
Drug: Nabilone |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 |
Resource links provided by NLM:
Further study details as provided by University of Manitoba:
Primary Outcome Measures:
- Visual Analogue Scale for Pain [ Time Frame: Baseline, 2, 4 and 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | January 2009 |
| Study Completion Date: | April 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
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
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| 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 |
| Study First Received: | June 17, 2008 |
| Last Updated: | April 28, 2011 |
| Health Authority: | Health Canada: Clinical Trials and Special Access Program Canada: Ethics Review Committee |
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 Nabilone Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 17, 2013