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Completed

NCT Number: NCT00699634

Nabilone for the Treatment of 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.

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Key information

Conditions

Phantom Limb Pain Nervous System Diseases Neuralgia Neurobehavioral Manifestations Neurologic Manifestations Neuromuscular Diseases Neuropathic Pain Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Peripheral Nervous System Diseases Phantom Limb Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Rehabilitation Hospital

Winnipeg, Manitoba, R3A 1M4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nabilone

Drug

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 names: Cesemet

Primary outcomes

  1. Visual Analogue Scale for Pain

    Time frame: Baseline, 2, 4 and 6 weeks

Secondary outcomes

  1. Depression Anxiety and Stress Scale

    Time frame: Baseline, 2, 4 and 6 weeks

  2. Groningen Sleep Quality Scale

    Time frame: Baseline, 2, 4 and 6 weeks

  3. SF-36

    Time frame: Baseline, 2, 4 and 6 weeks

  4. Frequency of phantom limb pain

    Time frame: Baseline, 2, 4 and 6 weeks

  5. Daily prosthetic wearing time

    Time frame: Baseline, 2, 4 and 6 weeks

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Valeant Canada Limited

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jun 18, 2008
Registry last updated
Apr 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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