NCT00699634

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 18, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

April 29, 2011

Status Verified

April 1, 2011

Enrollment Period

2.1 years

First QC Date

June 17, 2008

Last Update Submit

April 28, 2011

Conditions

Phantom Limb PainNeuropathic Pain

Keywords

NeuropathicPainPhantomLimb

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale for Pain

    Baseline, 2, 4 and 6 weeks

Secondary Outcomes (5)

  • Depression Anxiety and Stress Scale

    Baseline, 2, 4 and 6 weeks

  • Groningen Sleep Quality Scale

    Baseline, 2, 4 and 6 weeks

  • SF-36

    Baseline, 2, 4 and 6 weeks

  • Frequency of phantom limb pain

    Baseline, 2, 4 and 6 weeks

  • Daily prosthetic wearing time

    Baseline, 2, 4 and 6 weeks

Interventions

NabiloneDRUG

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.

Also known as: Cesemet

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient has been diagnosed with phantom limb pain by a Rehabilitation Medicine Specialist.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rehabilitation Hospital

Winnipeg, Manitoba, R3A 1M4, Canada

Location

MeSH Terms

Conditions

Phantom LimbNeuralgiaPain

Interventions

nabilone

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPain, PostoperativePostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsPeripheral Nervous System DiseasesNeuromuscular Diseases

Study Officials

  • Ryan Q Skrabek, MD, FRCPC

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 18, 2008

Study Start

January 1, 2009

Primary Completion

February 1, 2011

Study Completion

April 1, 2011

Last Updated

April 29, 2011

Record last verified: 2011-04

Locations

CA(1)