Insomnia and Osteoarthritis Study



Status:Completed
Conditions:Arthritis, Insomnia Sleep Studies, Osteoarthritis (OA)
Therapuetic Areas:Psychiatry / Psychology, Rheumatology
Healthy:No
Age Range:18 - 64
Updated:3/16/2019
Start Date:January 2006
End Date:December 2013

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The Efficacy of Eszopiclone (Lunesta) for Chronic Insomnia Associated With Osteoarthritis.

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.


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
We found this trial at
1
site
1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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