How do Sleeping Pills Affect Pain in the Brain?

Sponsor

University of California, San Diego (Other)

Overall Status

Terminated

CT.gov ID

NCT00414037

Collaborator

Sunovion (Industry)

Enrollment

Location

Arms

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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 :

Dec 1, 2006

Actual Primary Completion Date :

Dec 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Arms and Interventions

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 Placebo-treatment

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

Placebo-treatment

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age 20-55
Primary Insomnia

Exclusion Criteria:

Certain medical conditions/medications
MRI related

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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
Sunovion

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Martin Paulus, Professor of Psychiatry, University of California, San Diego

ClinicalTrials.gov Identifier:

NCT00414037

Other Study ID Numbers:

060881

First Posted:

Dec 21, 2006

Last Update Posted:

Oct 26, 2015

Last Verified:

Oct 1, 2015

Keywords provided by Martin Paulus, Professor of Psychiatry, University of California, San Diego

Additional relevant MeSH terms:

Sleep Initiation and Maintenance Disorders

Eszopiclone

Study Results

No Results Posted as of Oct 26, 2015