How do Sleeping Pills Affect Pain in the Brain?
Information source: University of California, San Diego
Information obtained from ClinicalTrials.gov on August 08, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Primary Insomnia
Intervention: Eszopiclone (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University of California, San Diego Official(s) and/or principal investigator(s):
Martin P Paulus, M.D., Principal Investigator, Affiliation: University of California, San Diego
Overall contact:
Lindsay Reinhardt, B.S., Phone: 858-534-7556, Email: insomniastudy@gmail.com
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.
Clinical Details
Official title: Subchronic Effects of Eszopiclone (Lunesta) on Pain Behavior and Circuitry in Primary Insomnia
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment
Primary outcome: Sleep and pain ratings following 1 week of treatment as compared to baseline
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.
Eligibility
Minimum age: 20 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 20-55
- Primary Insomnia
Exclusion Criteria:
- Certain medical conditions/medications
- MRI related
Locations and Contacts
Lindsay Reinhardt, B.S., Phone: 858-534-7556, Email: insomniastudy@gmail.com
UCSD Department of Psychiatry, Laboratory of Biological Dynamics and Theoretical Medicine, La Jolla, California 92037, United States; Recruiting
Martin P Paulus, M.D., Principal Investigator
Additional Information
Starting date: December 2006
Last updated: December 19, 2006
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