How do Sleeping Pills Affect Pain in the Brain?

NCT00414037 | Terminated Phase 4

• 1 other identifier: 060881
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Insomnia

Keywords

insomnia; lunesta; eszopiclone; pain; fMRI

Outcome Measures

Primary Outcomes (1)

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

  1 week

Study Arms (2)

eszopiclone (Lunesta) 3mg

EXPERIMENTAL

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

Drug: Eszopiclone

Placebo

PLACEBO COMPARATOR

Placebo-treated group

Drug: Placebo

Interventions

Eszopiclone DRUG

eszopiclone (Lunesta) 3mg

Placebo DRUG

Placebo-treatment

Placebo

Eligibility Criteria

• Age: 20 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-55
• Primary Insomnia

You may not qualify if:

• Certain medical conditions/medications
• MRI related

Sponsors & Collaborators

• University of California, San Diego: lead
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

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

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Pain

Interventions

Eszopiclone

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Pyridines

Study Officials

• Martin P Paulus, M.D.

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: December 19, 2006
• First Posted: December 21, 2006
• Study Start: December 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: October 26, 2015

Record last verified: 2015-10

Locations

US (1)