Recruiting
Phase 2

Nabilone

Sponsor:

University Health Network, Toronto

Code:

NCT00384410

Conditions

Pain

Insomnia

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Nabilone

Study Details

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.

Conditions

Pain

Insomnia

Study ID

NCT00384410

Start date

Dec, 2005

Status verified date

Nov, 2005

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

16 participants

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Nabilone

Primary outcome measure

  • The primary analysis variable will be the change in the mean of the sleep efficiency as measured by overnight polysomnography. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Sharon A. Chung, PhD

416-603-5275sachung@uhnres.utoronto.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5T 2S8

Contacts

Sharon A. Chung, PhD

416-603-5275sachung@uhnres.utoronto.ca

Principal Investigator:

Colin M. Shapiro, MBBCh, PhD

More Information

Sponsor

University Health Network, Toronto

Last update posted

Oct 6, 2006

Last verified

Nov, 2005

Keywords

  • Pain
  • Insomnia
  • Nabilone

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2006-10-06.