- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00414037
How do Sleeping Pills Affect Pain in the Brain?
Subchronic Effects of Eszopiclone (Lunesta) on Pain Behavior and Circuitry in Primary Insomnia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
It is well known that chronic pain syndromes are associated with alterations in sleep continuity and sleep architecture. Similarly, recent evidence indicates that sleep deprivation interferes with normal pain perception producing hyperalgesic changes, and with the regular analgesic effects of certain pain drugs (reviewed in Kundermann B et al., 2004). However, the role of the nonbenzodiazepine hypnotic agents in pain perception is not well understood. Lunesta (eszopiclone), unlike other nonbenzodiazepine sleep medications, is approved for long-term use (no significant addictive effects of the drug are observed following the treatment of up to 6mo). Its antinociceptive properties have not been examined and, if found, could potentiate the use of this drug for pain control, especially in patients with comorbid chronic pain and insomnia.
The objective of this proposal is to use Functional Magnetic Resonance Imaging (fMRI) with an experimental pain paradigm in a group of chronic insomnia patients. The study will consist of three sessions, the first of which will include questionnaires, and a mental and physical health evaluation including an EKG and blood draw. Following the initial screening session subjects will be randomly assigned to either the study drug or placebo groups, and complete 2 additional identical study sessions using fMRI. The first fMRI session will be before taking the drug/placebo, and the second session will be after taking the study drug/placebo nightly for 1 week. During these fMRI sessions, subjects will undergo psychophysical testing of their sensitivity to warmth and heat and will rate various temperatures for pain intensity and pain unpleasantness. Subjects will also complete additional tasks including motor inhibition and face matching during scanning.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
California
-
La Jolla, California, United States, 92037
- UCSD Department of Psychiatry, Laboratory of Biological Dynamics and Theoretical Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age 20-55
- Primary Insomnia
Exclusion Criteria:
- Certain medical conditions/medications
- MRI related
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: eszopiclone (Lunesta) 3mg
Subchronic (1-week) administration of 3mg Lunesta (eszopiclone)
|
|
Placebo Comparator: Placebo
Placebo-treated group
|
Placebo-treatment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Sleep and pain ratings following 1 week of treatment as compared to baseline
Time Frame: 1 week
|
1 week
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Martin P Paulus, M.D., University of California, San Diego
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 060881
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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