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Clinical Trials/NCT00414037
NCT00414037TerminatedPhase 4

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

University of California, San Diego1 site in 1 country40 target enrollmentStarted: December 2006Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Terminated
Enrollment
40
Locations
1
Primary Endpoint
Sleep and pain ratings following 1 week of treatment as compared to baseline

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age 20-55
  • Primary Insomnia

Exclusion Criteria

  • Certain medical conditions/medications
  • MRI related

Arms & Interventions

Placebo

Placebo Comparator

Placebo-treated group

Intervention: Placebo (Drug)

eszopiclone (Lunesta) 3mg

Experimental

Subchronic (1-week) administration of 3mg Lunesta (eszopiclone)

Intervention: Eszopiclone (Drug)

Outcomes

Primary Outcomes

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

Time Frame: 1 week

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Martin Paulus

Professor of Psychiatry

University of California, San Diego

Study Sites (1)

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