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

February 25, 2016 updated by: Kettering Health Network
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

We will enroll 4 normal, healthy, adult male volunteers who will undergo screening tests (labs, EKGs, medical history, physical exam, and MRI of the brain) for safety. If eligible, they will return for three separate positron emission tomography (PET) scans. Over the course of the three study visits, each subject will receive eszopiclone (Lunesta), zolpidem (ambien) and a placebo in random order.

After each medication or placebo dose, a PET scan will be done using a [11-C] flumazenil (Romazicon). The flumazenil will help us measure the binding of the study medications to chemical receptors called GABA receptors in certain parts of the brain.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Kettering, Ohio, United States, 45429
        • Kettering Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Claustrophobia.
  • Donation of 1 or more units of blood (approximately 450ml), or acute loss of an equivalent amount of blood within 90 days prior to study drug administration.
  • Have received an experimental drug or used an experimental medical device within 90 days of planned start of treatment with drugs for this study.
  • Use of any prescription or over the counter medication, or herbal medication (not including non-steroidal anti-inflammatory drugs) within 2 weeks of the first PET scan. Of particular concern would be GABA-ergic compounds and CYP3A4 inhibitors. Exclusion should also be considered if the subject has taken a drug with a long half-life (or of any metabolite) even if taken outside the two week time window. However, the subject can still be enrolled if, in the opinion of the investigator, such medication taken in that timeframe will not interfere with the results of the study.
  • Psychological or emotional problems that would render the informed consent invalid or limit the ability of the subject to comply with the study requirements.
  • Any condition that in the opinion of the investigator would complicate or compromise the study, or the well-being of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
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
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.
Other Names:
  • Lunesta
  • Ambien

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
We will measure GABA receptor binding by PET imageing after each dose of study medication or placebo.
Time Frame: 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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kettering Health Network

Collaborators

Sunovion
Abiant, Inc.

Investigators

  • Principal Investigator: Joseph C Mantil, MD, PhD, Kettering Health Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

October 27, 2008

First Submitted That Met QC Criteria

October 28, 2008

First Posted (Estimate)

October 29, 2008

Study Record Updates

Last Update Posted (Estimate)

February 26, 2016

Last Update Submitted That Met QC Criteria

February 25, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-104-SEPR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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