Use of the Cannabinoid Nabilone for the Promotion of Sleep in Chronic, Non-Malignant Pain Patients

Phase 2

• Conditions: Pain; Insomnia

• Registration Number: NCT00384410
• Lead Sponsor: University Health Network, Toronto

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 ( 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 Timeline

• Status Verified: 2005-11
• Study Start: 2005-12
• Study First Submitted: 2006-10-04
• Study First Submitted QC: 2006-10-04
• Last Update Submitted: 2006-10-04
• Study First Posted: 2006-10-06
• Last Update Posted: 2006-10-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
The primary analysis variable will be the change in the mean of the sleep efficiency as measured by overnight polysomnography.

Secondary Outcome Measures

Name	Time	Method
• The key secondary efficacy variable will be the change in the total sleep time with nabilone treatment as compared to placebo

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada