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

Sponsors and Collaborators:	University of Manitoba Valeant Canada
Information provided by:	University of Manitoba
ClinicalTrials.gov Identifier:	NCT00699634

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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 Depression

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
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	May 2010 (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.

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

Contacts

Contact: Ryan Q Skrabek, MD, FRCPC	204-787-2270	rskrabek@hotmail.com
Contact: Tracey Olafson, RN	204-787-2725	tolafson@exchange.hsc.mb.ca

Locations

Canada, Manitoba
Rehabilitation Hospital	Recruiting
Winnipeg, Manitoba, Canada, R3A 1M4
Contact: Ryan Q Skrabek, MD, FRCPC 204-787-2270 rskrabek@hotmail.com
Contact: Tracey Olafson, RN 204-787-2725 tolafson@exchange.hsc.mb.ca
Principal Investigator: Ryan Q Skrabek, MD, FRCPC
Sub-Investigator: Amarjit Arneja, MD, FRCPC

Sponsors and Collaborators

University of Manitoba

Valeant Canada

Investigators

Principal Investigator:

Ryan Q Skrabek, MD, FRCPC

University of Manitoba

More Information

No publications provided

Responsible Party:	University of Manitoba ( Dr. Ryan Quinlan Skrabek )
Study ID Numbers:	1975, REB: B2007:129, Impact: RI07:119, Health Canada: 116697
Study First Received:	June 17, 2008
Last Updated:	August 19, 2009
ClinicalTrials.gov Identifier:	NCT00699634 History of Changes
Health Authority:	Health Canada: Clinical Trials and Special Access Program; Canada: Ethics Review Committee

Keywords provided by University of Manitoba:

Neuropathic
Pain
Phantom
Limb

Study placed in the following topic categories:

Tranquilizing Agents
Psychotropic Drugs
Quality of Life
Antiemetics
Central Nervous System Depressants
Pain
Phantom Limb

Nabilone
Signs and Symptoms
Neurologic Manifestations
Anti-Anxiety Agents
Peripheral Nervous System Agents
Neurobehavioral Manifestations
Perceptual Disorders

Additional relevant MeSH terms:

Tranquilizing Agents
Nervous System Diseases
Physiological Effects of Drugs
Psychotropic Drugs
Gastrointestinal Agents
Central Nervous System Depressants
Antiemetics
Phantom Limb
Nabilone
Pharmacologic Actions

Signs and Symptoms
Autonomic Agents
Therapeutic Uses
Neurologic Manifestations
Anti-Anxiety Agents
Peripheral Nervous System Agents
Neurobehavioral Manifestations
Central Nervous System Agents
Perceptual Disorders

ClinicalTrials.gov processed this record on August 28, 2009