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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pain Insomnia | Drug: Nabilone | Phase 2 |
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 : | 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 |

- The primary analysis variable will be the change in the mean of the sleep efficiency as measured by overnight polysomnography.
- • 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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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
Contact: Sharon A. Chung, PhD | 416-603-5275 | sachung@uhnres.utoronto.ca |
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 |
Principal Investigator: | Colin M. Shapiro, MBBCh, PhD | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00384410 |
Other Study ID Numbers: |
NAB-20051 |
First Posted: | October 6, 2006 Key Record Dates |
Last Update Posted: | October 6, 2006 |
Last Verified: | November 2005 |
Pain Insomnia Nabilone |
Sleep Initiation and Maintenance Disorders Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Mental Disorders Nabilone Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |