Nabilone for the Treatment of Phantom Limb Pain - Full Text View

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:

MedlinePlus related topics: Anxiety

Drug Information available for: Nabilone

U.S. FDA Resources

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:

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 (Adult, Senior)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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 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

ClinicalTrials.gov processed this record on September 27, 2016