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

NCT ID: NCT00384410

Last Updated: 2006-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-12-31

Brief Summary

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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

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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

Conditions

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Pain Insomnia

Keywords

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Pain Insomnia Nabilone

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Nabilone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role collaborator

University Health Network, Toronto

OTHER

Sponsor Role lead

Principal Investigators

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Colin M. Shapiro, MBBCh, PhD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Sharon A. Chung, PhD

Role: CONTACT

Phone: 416-603-5275

Email: [email protected]

Facility Contacts

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Sharon A. Chung, PhD

Role: primary

Other Identifiers

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NAB-20051

Identifier Type: -

Identifier Source: org_study_id