Status:
COMPLETED
Insomnia and Osteoarthritis Study
Lead Sponsor:
Johns Hopkins University
Conditions:
Osteoarthritis
Insomnia
Eligibility:
All Genders
18-64 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00374556
Start Date
January 1 2006
End Date
December 1 2013
Last Update
March 14 2019
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287