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

NCT00384410 | Unknown Phase 2

• 1 other identifier: NAB-20051
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Insomnia

Keywords

Pain; Insomnia; Nabilone

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

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

Interventions

Nabilone DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Bausch Health Americas, Inc.: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Pain; Sleep Initiation and Maintenance Disorders

Interventions

nabilone

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Colin M. Shapiro, MBBCh, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon A. Chung, PhD

CONTACT

416-603-5275; sachung@uhnres.utoronto.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 4, 2006
• First Posted: October 6, 2006
• Study Start: December 1, 2005
• Last Updated: October 6, 2006

Record last verified: 2005-11

Locations

CA (1)