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Insomnia and Osteoarthritis Study

Information source: Johns Hopkins University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Osteoarthritis; Insomnia

Intervention: eszopiclone, 2 mg, qhs (Drug)

Phase: N/A

Status: Completed

Sponsored by: Johns Hopkins University

Official(s) and/or principal investigator(s):
Michael T. Smith, Ph.D., Principal Investigator, Affiliation: Johns Hopkins University

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

Two-week average sleep diary and actigraphy measures of Wake After Sleep Onset Time; measured at six weeks.

Laboratory Pain Sensitivity Measures; levels at six weeks.

Two-week average diary ratings of pain severity; score at six weeks.

Secondary outcome:

WOMAC Disability & Joint Stiffness Indices; measured at 12 weeks.

Quality of Life (SF-36); measured at 12 weeks.

Insomnia Severity Index; measured at 12 weeks.

Eligibility

Minimum age: 18 Years. Maximum age: 64 Years. Gender(s): Both.

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 OA

- Report at least typical arthritic pain>4 out of 10 (0=no pain, 10=the most extreme

pain imaginable)

- Meet DSM-IV and 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, THC, alcohol, and stimulants), c) abnormal liver enzyme panel

Locations and Contacts

Johns Hopkins Hospital, Baltimore, Maryland 21287, United States
Additional Information

Starting date: January 2006
Last updated: March 10, 2014

Page last updated: August 23, 2015

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