How do Sleeping Pills Affect Pain in the Brain?

Phase 4

Terminated

• Conditions: Primary Insomnia
• Interventions: Drug: Placebo; Drug: Eszopiclone

• Registration Number: NCT00414037
• Lead Sponsor: University of California, San Diego

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.

Study Timeline

• Study Start: 2006-12
• Study First Submitted: 2006-12-19
• Study First Submitted QC: 2006-12-19
• Study First Posted: 2006-12-21
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-23
• Last Update Posted: 2015-10-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 20-55
• Primary Insomnia

Exclusion Criteria

• Certain medical conditions/medications
• MRI related

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo-treated group
eszopiclone (Lunesta) 3mg	Eszopiclone	Subchronic (1-week) administration of 3mg Lunesta (eszopiclone)

Primary Outcome Measures

Name	Time	Method
Sleep and pain ratings following 1 week of treatment as compared to baseline	1 week

Trial Locations

Locations (1)

UCSD Department of Psychiatry, Laboratory of Biological Dynamics and Theoretical Medicine; 🇺🇸 La Jolla, California, United States