How do Sleeping Pills Affect Pain in the Brain?
Information source: University of California, San Diego
Information obtained from ClinicalTrials.gov on October 19, 2009
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
|
