Clinical trial NCT00374556: Insomnia and Osteoarthritis Study
Official title: The Efficacy of Eszopiclone (Lunesta) for Chronic Insomnia Associated With Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Insomnia
Keywords: eszopiclone
insomnia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2006-09-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Wake After Sleep Onset (WASO)
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: Time in Bed
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: Sleep Latency (SL)
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: Number of Awakenings
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: Total Sleep Time (TST)
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: Sleep Efficiency (SE)
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: Sleep Quality (SQ)
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: WASO as Assessed by Actigraphy
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: TST as Assessed by Actigraphy
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: Sleep Efficiency as Assessed by Actigraphy
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: Sleep Latency as Assessed by Actigraphy
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: Insomnia Severity Index (ISI) Mean Total Scores
timeFrame: Mean of baseline, 6 week follow-up, and 12 week follow-up
measure: Diffuse Noxious Inhibitory Control (DNIC) Index Scores
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up
measure: Temporal Summation (TS)
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up at 46, 48, and 50 degrees C
measure: Mean Level of Pain Experienced Throughout the Day
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up
measure: Pain as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Pain Severity Subscale
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up
Secondary outcomes:
measure: Heat Pain Threshold
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up
measure: Heat Pain Tolerance (HPTOL)
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up
measure: Pressure Pain Threshold
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up
measure: Quality of Life as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Disability Subscale
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up
measure: Quality of Life as Assessed by the Short Form-36 (SF-36) Physical Health Component Summary
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up
measure: Quality of Life as Assessed by the Short Form-36 (SF-36) Mental Health Component Summary
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up
measure: Joint Stiffness as Assessed by the Western Ontario and McMaster Universities Index of Osteoarthritis (WOMAC) Joint Stiffness Subscale
timeFrame: Mean of baseline, 6 week follow-up and 12 week follow-up
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Michael T. Smith, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: