Insomnia and Osteoarthritis Study
This study has been completed.
Information provided by (Responsible Party):
Michael T. Smith, Ph.D, Johns Hopkins University
First received: September 8, 2006
Last updated: March 10, 2014
Last verified: March 2014
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.
Drug: eszopiclone, 2 mg, qhs
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
||The Efficacy of Eszopiclone (Lunesta) for Chronic Insomnia Associated With Osteoarthritis.
Primary Outcome Measures:
- 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 Measures:
- 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.
| Estimated Enrollment:
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||December 2013 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||18 Years to 64 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374556
|Johns Hopkins Hospital
|Baltimore, Maryland, United States, 21287 |
Johns Hopkins University
||Michael T. Smith, Ph.D.
||Johns Hopkins University
No publications provided
||Michael T. Smith, Ph.D, Professor, Johns Hopkins University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 8, 2006
||March 10, 2014
||United States: Institutional Review Board
Keywords provided by Johns Hopkins University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 31, 2014
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents