- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00384410
Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients
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 Overview
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 Type
Enrollment
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Sharon A. Chung, PhD
- Phone Number: 416-603-5275
- Email: sachung@uhnres.utoronto.ca
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5T 2S8
- Recruiting
- University Health Network
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Contact:
- Sharon A. Chung, PhD
- Phone Number: 416-603-5275
- Email: sachung@uhnres.utoronto.ca
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Principal Investigator:
- Colin M. Shapiro, MBBCh, PhD
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Sub-Investigator:
- Sharon A. Chung, PhD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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The primary analysis variable will be the change in the mean of the sleep efficiency as measured by overnight polysomnography.
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Secondary Outcome Measures
Outcome Measure |
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• The key secondary efficacy variable will be the change in the total sleep time with nabilone treatment as compared to placebo
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Sleep Disorders, Intrinsic
- Dyssomnias
- Sleep Wake Disorders
- Sleep Initiation and Maintenance Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Anti-Anxiety Agents
- Nabilone
Other Study ID Numbers
- NAB-20051
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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