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
|Condition or disease||Intervention/treatment||Phase|
|Pain Insomnia||Drug: Nabilone||Phase 2|
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.
To evaluate if nabilone (Cesamet) is effective in improving sleep in patients with insomnia and chronic, non-malignant pain
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Crossover Assignment|
|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
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, PhDfirstname.lastname@example.org|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5T 2S8|
|Contact: Sharon A. Chung, PhD 416-603-5275 email@example.com|
|Principal Investigator: Colin M. Shapiro, MBBCh, PhD|
|Sub-Investigator: Sharon A. Chung, PhD|
|Principal Investigator:||Colin M. Shapiro, MBBCh, PhD||University Health Network, Toronto|