How do Sleeping Pills Affect Pain in the Brain?

October 23, 2015 updated by: Martin Paulus, University of California, San Diego

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • La Jolla, California, United States, 92037
        • UCSD Department of Psychiatry, Laboratory of Biological Dynamics and Theoretical Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-55
  • Primary Insomnia

Exclusion Criteria:

  • Certain medical conditions/medications
  • MRI related

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eszopiclone (Lunesta) 3mg
Subchronic (1-week) administration of 3mg Lunesta (eszopiclone)
Placebo Comparator: Placebo
Placebo-treated group
Placebo-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sleep and pain ratings following 1 week of treatment as compared to baseline
Time Frame: 1 week
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Martin P Paulus, M.D., University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

December 19, 2006

First Submitted That Met QC Criteria

December 19, 2006

First Posted (Estimate)

December 21, 2006

Study Record Updates

Last Update Posted (Estimate)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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