Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem

NCT00781482 | Withdrawn Phase 4

• 1 other identifier: 07-104-SEPR
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the interactions of a placebo and two FDA-approved sleeping medications, Eszopiclone (Lunesta) and Zolpidem (Ambien), with certain chemical receptors in the brain. We want to show that we can use positron emission tomography images to measure the binding of these medications to the receptors.

Conditions

Healthy

Keywords

Positron Emission Tomography; GABA receptor binding; Hypnotic Drugs; Eszopiclone; Zolpidem; [11-C] Flumazenil; Molecular imaging of the brain

Outcome Measures

Primary Outcomes (1)

• We will measure GABA receptor binding by PET imageing after each dose of study medication or placebo.

  PET scans will occur within 1-2 hours after study drug or placebo administration. Visits will occur approximately 1 week apart. . Subjects will have visits scheduled over approximately 6 weeks, including screening, scanning visits, and follow-up.

Study Arms (1)

1

EXPERIMENTAL

This is a crossover study. Each study drug will be administered (one at a time and in random order) to each subject on separate occasions over the course of the study.

Drug: eszopiclone, zolpidem, placebo

Interventions

eszopiclone, zolpidem, placebo DRUG

In random order, each subject will receive one study drug per visit over three visits. Visits will occur about 1 week apart. Each subject will eventually receive eszopiclone 3 mg., zolpidem 10 mg., and a placebo. PET scans will be done 1-2 hours after each dose.

Also known as: Lunesta, Ambien

1

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy Males age 18 to 35 inclusive
• Body Mass Index 18 to 30
• Willing to adhere to prohibitions and restrictions specified in protocol
• Must give informed consent.

You may not qualify if:

• Clinically significant abnormal lab values for chemistry, hematology or urinalysis at screening.
• Clinically significant abnormal physical exam, vital signs, or 12-lead EKG at screening
• Significant history of or current significant medical illness.
• Significant history of or current psychiatric or neurological illness or sleep apnea.
• Participation in another research study involving exposure to ionizing radiation within the last 12 months.
• Any clinically significant MR abnormality which may be relevant to the study.
• Metal implants which are relevant for MR or PET procedures or data.
• History of epilepsy or fits or unexplained blackouts.
• Serology positive for Hepatitis B surface antigen, Hepatitis C antibodies, or HIV antibodies.
• Positive urine screen for drugs of abuse.
• Positive alcohol screen.
• Known or suspected alcoholism or drug addiction even if currently abstaining
• Drinks on average more than 8 cups of coffee, tea, cocoa, or cola per day.
• Smoking cigarettes within 3 months prior to study drug administration.
• Clinically significant acute illnes within 7 days of study drug administration.

Sponsors & Collaborators

• Kettering Health Network: lead
• Abiant, Inc.: collaborator
• Sumitomo Pharma America, Inc.: collaborator

Study Sites (1)

Kettering Medical Center

Kettering, Ohio, 45429, United States

Location

MeSH Terms

Interventions

Eszopiclone; Zolpidem

Intervention Hierarchy (Ancestors)

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

Study Officials

• Joseph C Mantil, MD, PhD

  Kettering Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 29, 2008
• Last Updated: February 26, 2016

Record last verified: 2016-02

Locations

US (1)