How do Sleeping Pills Affect Pain in the Brain?
Primary Purpose
Primary Insomnia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Eszopiclone
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary Insomnia focused on measuring insomnia, lunesta, eszopiclone, pain, fMRI
Eligibility Criteria
Inclusion Criteria:
- Age 20-55
- Primary Insomnia
Exclusion Criteria:
- Certain medical conditions/medications
- MRI related
Sites / Locations
- UCSD Department of Psychiatry, Laboratory of Biological Dynamics and Theoretical Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
eszopiclone (Lunesta) 3mg
Placebo
Arm Description
Subchronic (1-week) administration of 3mg Lunesta (eszopiclone)
Placebo-treated group
Outcomes
Primary Outcome Measures
Sleep and pain ratings following 1 week of treatment as compared to baseline
Secondary Outcome Measures
Full Information
NCT ID
NCT00414037
First Posted
December 19, 2006
Last Updated
October 23, 2015
Sponsor
University of California, San Diego
Collaborators
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00414037
Brief Title
How do Sleeping Pills Affect Pain in the Brain?
Official Title
Subchronic Effects of Eszopiclone (Lunesta) on Pain Behavior and Circuitry in Primary Insomnia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2015
Overall Recruitment Status
Terminated
Why Stopped
Funding terminated by sponsor, insufficient data collection
Study Start Date
December 2006 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
If you are age 20-55 years old and have trouble falling or staying asleep, then please contact a UCSD research team to find out how a study drug affects these symptoms and how your brain works. This is a one-week experimental pain research study using a study drug compared to placebo. Your participation will include questionnaires, a physical exam and functional Magnetic Resonance Imaging (fMRI) brain imaging techniques. We will test pain perception by applying brief mild to moderate heat pain to the forearm, and also have you perform simple computer tasks while we image and record brain activity using fMRI.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Insomnia
Keywords
insomnia, lunesta, eszopiclone, pain, fMRI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
eszopiclone (Lunesta) 3mg
Arm Type
Experimental
Arm Description
Subchronic (1-week) administration of 3mg Lunesta (eszopiclone)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-treated group
Intervention Type
Drug
Intervention Name(s)
Eszopiclone
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo-treatment
Primary Outcome Measure Information:
Title
Sleep and pain ratings following 1 week of treatment as compared to baseline
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 20-55
Primary Insomnia
Exclusion Criteria:
Certain medical conditions/medications
MRI related
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin P Paulus, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD Department of Psychiatry, Laboratory of Biological Dynamics and Theoretical Medicine
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
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How do Sleeping Pills Affect Pain in the Brain?
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