Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00414037
Status:
TERMINATED
Last Update Posted:
2015-10-26
First Post:
2006-12-19
Brief Title:
How do Sleeping Pills Affect Pain in the Brain
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Subchronic Effects of Eszopiclone Lunesta on Pain Behavior and Circuitry in Primary Insomnia
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding terminated by sponsor insufficient data collection
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 drugplacebo and the second session will be after taking the study drugplacebo 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
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 drugplacebo and the second session will be after taking the study drugplacebo 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None