Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00384410
Status:
UNKNOWN
Last Update Posted:
2006-10-06
First Post:
2006-10-04
Brief Title:
Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic Non-Malignant Pain Patients
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 ie 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
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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None