HealthyPhase 4NCT00781482
Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem
A Phase 4 study of Healthy, run by Kettering Health Network at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Healthy
- Being tested
- eszopiclone, zolpidem, placebo
- Keywords
- Positron Emission Tomography, GABA receptor binding, Hypnotic Drugs, Eszopiclone, Zolpidem, [11-C] Flumazenil, Molecular imaging of the brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eszopiclone, zolpidem, placeboDrug
Also called Lunesta, Ambien
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: eszopiclone, zolpidem, placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
We will measure GABA receptor binding by PET imageing after each dose of study medication or placebo.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
Why it stopped: Sponsor elected not to conduct study at this time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- Abiant, Inc., Sumitomo Pharma America, Inc.
- Investigators
- Joseph C Mantil, MD, PhD, Principal investigator, Kettering Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781482
- Sponsor's protocol ID
- 07-104-SEPR
- Status last verified
- Feb 2016
- First submitted
- 27 Oct 2008
- Last updated
- 26 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positron Emission Tomography Assessment of the Central Nervous System Effects of Eszopiclone and Zolpidem
- ClinicalTrials.gov ID
- NCT00781482
- Acronym / sponsor ID
- 07-104-SEPR
- Conditions
- Healthy
- Keywords
- Positron Emission Tomography, GABA receptor binding, Hypnotic Drugs, Eszopiclone, Zolpidem, [11-C] Flumazenil, Molecular imaging of the brain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor elected not to conduct study at this time.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Collaborators
- Abiant, Inc., Sumitomo Pharma America, Inc.
- First posted
- 29 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: eszopiclone, zolpidem, placeboThis 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eszopiclone, zolpidem, placeboAlso: Lunesta, AmbienIn 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. | Drug | 1 |
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph C Mantil, MD, PhD principal investigator
Kettering Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study of Healthy, run by Kettering Health Network at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2016.