How do Sleeping Pills Affect Pain in the Brain?



Status:Terminated
Conditions:Insomnia Sleep Studies
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:20 - 55
Updated:4/21/2016
Start Date:December 2006
End Date:December 2008

Use our guide to learn which trials are right for you!

Subchronic Effects of Eszopiclone (Lunesta) on Pain Behavior and Circuitry in Primary Insomnia

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.

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.

Inclusion Criteria:

- Age 20-55

- Primary Insomnia

Exclusion Criteria:

- Certain medical conditions/medications

- MRI related
We found this trial at
1
site
?
mi
from
La Jolla, CA
Click here to add this to my saved trials