Nabilone for the Treatment of Phantom Limb Pain

This study has been completed.

Sponsor:

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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 17, 2008

Last Updated Date

April 28, 2011

Start Date ^ICMJE

January 2009

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Visual Analogue Scale for Pain [ Time Frame: Baseline, 2, 4 and 6 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00699634 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Nabilone for the Treatment of Phantom Limb Pain

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Phantom Limb Pain
Neuropathic Pain

Intervention ^ICMJE

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

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

April 2011

Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Administrative Information

NCT Number ^ICMJE

NCT00699634

Other Study ID Numbers ^ICMJE

1975, REB: B2007:129, Impact: RI07:119, Health Canada: 116697

Has Data Monitoring Committee

Yes

Responsible Party

Dr. Ryan Quinlan Skrabek, University of Manitoba

Study Sponsor ^ICMJE

University of Manitoba

Collaborators ^ICMJE

Valeant Canada Limited

Investigators ^ICMJE

Principal Investigator:

Ryan Q Skrabek, MD, FRCPC

University of Manitoba

Information Provided By

University of Manitoba

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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