How do Sleeping Pills Affect Pain in the Brain?

NCT ID: NCT00414037

Last Updated: 2015-10-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-12-31

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.

Conditions

Primary Insomnia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

eszopiclone (Lunesta) 3mg

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

Group Type: EXPERIMENTAL

Eszopiclone

Intervention Type: DRUG

Placebo

Placebo-treated group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo-treatment

Interventions

Eszopiclone

Intervention Type: DRUG

Placebo

Placebo-treatment

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age 20-55
• Primary Insomnia

Exclusion Criteria

• Certain medical conditions/medications
• MRI related

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sumitomo Pharma America, Inc.

INDUSTRY

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Martin Paulus

Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin P Paulus, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

UCSD Department of Psychiatry, Laboratory of Biological Dynamics and Theoretical Medicine

La Jolla, California, United States

Countries

United States

Other Identifiers

060881

Identifier Type: -

Identifier Source: org_study_id