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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto
• Collaborators: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Dronabinol; Nabilone

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.