How do Sleeping Pills Affect Pain in the Brain?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00414037
Recruitment Status : Terminated (Funding terminated by sponsor, insufficient data collection)
First Posted : December 21, 2006
Last Update Posted : October 26, 2015
Information provided by (Responsible Party):
Martin Paulus, 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.

Condition or disease Intervention/treatment Phase
Primary Insomnia Drug: Eszopiclone Drug: Placebo Phase 4

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  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Subchronic Effects of Eszopiclone (Lunesta) on Pain Behavior and Circuitry in Primary Insomnia
Study Start Date : December 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Eszopiclone
U.S. FDA Resources

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

Primary Outcome Measures :
  1. Sleep and pain ratings following 1 week of treatment as compared to baseline [ Time Frame: 1 week ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Age 20-55
  • Primary Insomnia

Exclusion Criteria:

  • Certain medical conditions/medications
  • MRI related

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00414037

United States, California
UCSD Department of Psychiatry, Laboratory of Biological Dynamics and Theoretical Medicine
La Jolla, California, United States, 92037
Sponsors and Collaborators
University of California, San Diego
Principal Investigator: Martin P Paulus, M.D. University of California, San Diego

Responsible Party: Martin Paulus, Professor of Psychiatry, University of California, San Diego Identifier: NCT00414037     History of Changes
Other Study ID Numbers: 060881
First Posted: December 21, 2006    Key Record Dates
Last Update Posted: October 26, 2015
Last Verified: October 2015

Keywords provided by Martin Paulus, University of California, San Diego:

Additional relevant MeSH terms:
Sleep Initiation and Maintenance Disorders
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs