Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients

• Sponsor: University Health Network, Toronto
• Collaborator: Valeant Pharmaceuticals International, Inc.
• Information provided by: University Health Network, Toronto

Study Description

Brief Summary:

Sleep disturbance is perhaps one of the most prevalent complaints of patients with long-standing painful conditions. Nabilone is a medication that is approved by Health Canada as an anti-emetic (prevent vomiting) for patients undergoing chemotherapy. Nabilone, due to its sleep promoting properties, is sometimes prescribed by physicians to pain patients to help improve their sleep. However, there is no direct research evidence to either support or refute this practice. This study will investigate if nabilone is effective in improving sleep in insomnia and pain patients.

Condition or disease	Intervention/treatment	Phase
Pain; Insomnia	Drug: Nabilone	Phase 2

Detailed Description:

Rationale:

The current evidence suggests a sleep promoting effect of THC. Although, there is some support from pre-clinical and small sample size human studies suggesting a direct sleep enhancing effect, it remains unclear from the larger clinical trials, whether improved sleep is an epiphenomena secondary to improvements in the primary outcome measures ( i.e., pain, nausea or spasticity). There are no studies evaluating the sleep promoting effects of THC or analogues in patients with primary insomnia or objectively evaluating sleep at baseline and following treatment with THC or analogues in patients suffering from chronic pain disorder and insomnia. Cannabinoids have the potential of simultaneously improving sleep and lessening chronic, non-malignant pain, thereby interrupting the vicious cycle of pain and sleep disturbance. An investigation of the efficacy of cannabinoids in treating insomnia in chronic, non-malignant pain patients is therefore warranted.

Research Question:

To evaluate if nabilone (Cesamet) is effective in improving sleep in patients with insomnia and chronic, non-malignant pain

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	16 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Double
Primary Purpose:	Treatment
Official Title:	Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients: A Placebo-Controlled, Randomized, Crossover Insomnia Pilot Study
Study Start Date :	December 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. The primary analysis variable will be the change in the mean of the sleep efficiency as measured by overnight polysomnography.

Secondary Outcome Measures :

1. • The key secondary efficacy variable will be the change in the total sleep time with nabilone treatment as compared to placebo

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria

• History of insomnia and chronic, non-malignant pain.
• Patient not currently being prescribed opiates for pain management
• Subject has no known clinically significant abnormal vital signs or other significant clinical findings at screening.

Exclusion criteria

• Patients with a history of sensitivity of cannabinoids.
• Patients currently taking hypnotics, psychotomimetic substances, CNS depressants or tricyclic antidepressants that may increase the CNS-depressant effects of nabilone.
• Patients with active cardiac disease or respiratory disorders.
• Patients with a history of psychotic reactions, schizophrenia, bipolar disorder or any serious untreated mental disorder.
• Presence of untreated sleep disorder (other than insomnia) as detected using the screening overnight PSG.
• Alcohol or substance abuse (according to DSM-IV) during the last 6 months prior to baseline.
• Patients with liver disease that may interfere with the clearance of nabilone.
• Patients who are nursing, pregnant or likely to become pregnant throughout the course of the study. During the study, female patients will be asked to use an effective method of birth control.

Contacts and Locations

Contacts

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Contact: Sharon A. Chung, PhD	416-603-5275	sachung@uhnres.utoronto.ca

Locations

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Canada, Ontario
University Health Network	Recruiting
Toronto, Ontario, Canada, M5T 2S8
Contact: Sharon A. Chung, PhD 416-603-5275 sachung@uhnres.utoronto.ca
Principal Investigator: Colin M. Shapiro, MBBCh, PhD
Sub-Investigator: Sharon A. Chung, PhD

Sponsors and Collaborators

University Health Network, Toronto

Valeant Pharmaceuticals International, Inc.

Investigators

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Principal Investigator:	Colin M. Shapiro, MBBCh, PhD	University Health Network, Toronto

More Information

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ClinicalTrials.gov Identifier:	NCT00384410 History of Changes
Other Study ID Numbers:	NAB-20051
First Posted:	October 6, 2006
Last Update Posted:	October 6, 2006
Last Verified:	November 2005

Keywords provided by University Health Network, Toronto:

Pain; Insomnia; Nabilone

Additional relevant MeSH terms:

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Sleep Initiation and Maintenance Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; 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; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists