Insomnia and Osteoarthritis Study

NCT ID: NCT00374556

Last Updated: 2019-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2013-12-31

Brief Summary

This research is being done to evaluate the effects of a sleeping pill (eszopiclone, Lunesta)in patients with arthritis of the knee who also suffer from chronic insomnia. This study will test whether Lunesta improves sleep, pain sensitivity, and daytime symptoms in patients with knee pain.

Conditions

Osteoarthritis; Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Eszopiclone

Eszopiclone 3mg capsules, once daily at bedtime for 12 weeks

Group Type: EXPERIMENTAL

Eszopiclone

Intervention Type: DRUG

3mg capsule, once daily at bedtime

Placebo

3mg placebo capsule, once daily at bedtime for 12 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

3mg placebo capsule, once daily at bedtime

Interventions

Placebo

3mg placebo capsule, once daily at bedtime

Intervention Type: DRUG

Eszopiclone

3mg capsule, once daily at bedtime

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 18-64
• Diagnosed with and under physicians care for osteoarthritis of the knee according to American College of Rheumatology Criteria with radiographic evidence demonstrating at least grade 1 osteoarthritis (OA)
• Report at least typical arthritic pain>4 out of 10 (0=no pain, 10=the most extreme pain imaginable)
• Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) and International Classification of Sleep Disorders, Revised definition (ICSD-R) criteria for either primary (psychophysiologic) insomnia or insomnia secondary to osteoarthritis
• Insomnia symptoms must include problems with middle of the night awakenings
• Insomnia symptom duration > 6 months
• Baseline, 2-week, sleep diary average wake after sleep onset time >30 minutes
• Baseline self-reported total sleep time < 6.5 hours per night
• Patients taking NSAID therapy for pain must be on a stable dose for a period of at least one month prior to initiating the study

Exclusion Criteria

• Intrinsic sleep disorders other than insomnia (sleep apnea, periodic limb movement disorder, etc)
• Significant rheumatologic or chronic pain disorders other than osteoarthritis of the knee, including fibromyalgia or the complaint of widespread pain impacting 4 quadrants, complex regional pain syndrome, post herpetic neuralgia, etc)
• Major medical disease (including, hepatic impairment, chronic obstructive pulmonary disease/compromised respiratory function, cancer, dementia, diabetes, congestive heart failure, cerebrovascular disease, raynaud's syndrome)
• Active major psychiatric disorders (including dementia or cognitive impairment) and history of schizophrenia or bipolar I disorder
• History of serious suicide attempt; 6) history of alcohol or substance (including prescription medications) abuse
• Pregnancy or plans to become pregnant within 6 months
• Intraarticular steroid injection within the past month
• Regular (>3 days/week) use of antidepressants, antipsychotics, and mood stabilizers, within the past two months
• Regular (> 3/week) use of myorelaxants, narcotics, sedative hypnotics, and anticonvulsants within the past one month
• Unwilling or unable to discontinue all use of the medications listed in #10 for two weeks prior to starting the study
• Unwilling or unable to discontinue all centrally acting agents and all analgesic usage within 24 hours of pain testing sessions
• Refusal to provide consent to contact patient's physician to establish diagnosis and obtain medical record information
• Regular tobacco or nicotine use
• Heavy caffeine use [(>2 cups of coffee/day (equivalent)
• History of previous allergic reaction or severe side effects to sedative hypnotics
• Use of potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, troleandomycin, ritonavir, nelfinavir)
• In addition, subjects will undergo in-laboratory blood tests prior to receiving drug and will be excluded from further participation if they exhibit: a) positive pregnancy test, b) positive toxicology (benzodiazepine, opioids, Tetrahydrocannabinol (THC), alcohol, and stimulants), c) abnormal liver enzyme panel

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael T. Smith, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00001703

Identifier Type: -

Identifier Source: org_study_id