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

Primary Purpose

Pain, Insomnia

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Nabilone

About this trial

This is an interventional treatment trial for Pain focused on measuring Pain, Insomnia, Nabilone

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University Health NetworkRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00384410

First Posted

October 4, 2006

Last Updated

October 4, 2006

Sponsor

University Health Network, Toronto

Collaborators

Bausch Health Americas, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00384410

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

November 2005

Overall Recruitment Status

Unknown status

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

University Health Network, Toronto

Collaborators

Bausch Health Americas, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pain, Insomnia

Keywords

Pain, Insomnia, Nabilone

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

16 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Nabilone

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sharon A. Chung, PhD

Phone

416-603-5275

sachung@uhnres.utoronto.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Colin M. Shapiro, MBBCh, PhD

Organizational Affiliation

University Health Network, Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Health Network

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sharon A. Chung, PhD

Phone

416-603-5275

sachung@uhnres.utoronto.ca

First Name & Middle Initial & Last Name & Degree

Colin M. Shapiro, MBBCh, PhD

First Name & Middle Initial & Last Name & Degree

Sharon A. Chung, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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