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

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ClinicalTrials.gov Identifier: NCT00384410

Recruitment Status : Unknown

Verified November 2005 by University Health Network, Toronto.
Recruitment status was: Recruiting

First Posted : October 6, 2006

Last Update Posted : October 6, 2006

Sponsor:

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


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

Resource links provided by the National Library of Medicine

Drug Information available for: Nabilone

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00384410

Contacts


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

Locations


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


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

More Information


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

Keywords provided by University Health Network, Toronto:


Pain Insomnia Nabilone

Additional relevant MeSH terms:


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

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