Status:
UNKNOWN
Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Pain
Insomnia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 (preve...
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 eff...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00384410
Start Date
December 1 2005
Last Update
October 6 2006
Active Locations (1)
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1
University Health Network
Toronto, Ontario, Canada, M5T 2S8