| June 17, 2008 |
| January 28, 2009 |
| January 2009 |
| 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 |
| |
| 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. |
| |
| Phase II |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
- Phantom Limb Pain
- Neuropathic Pain
|
| Drug: Nabilone |
| |
| |
| |
| Recruiting |
| 50 |
| October 2009 |
| August 2009 (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 |
|
|
| Canada |
|
| |
| NCT00699634 |
| Dr. Ryan Quinlan Skrabek, University of Manitoba |
| REB: B2007:129, Impact: RI07:119, Health Canada: 116697 |
| University of Manitoba |
| Valeant Canada |
| Principal Investigator: |
Ryan Q Skrabek, MD, FRCPC |
University of Manitoba |
|
|
| University of Manitoba |
| November 2008 |
