Insomnia and Osteoarthritis Study

Johns Hopkins University

Status

Completed

Conditions

Osteoarthritis

Insomnia

Treatments

Drug: Eszopiclone

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00374556

NA_00001703

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

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