A Study Using Functional Magnetic Resonance Imaging (fMRI) to Assess the Effects of Naltrexone SR/ Bupropion SR Therapy in Overweight or Obese Subjects - NCT00711477-11973 (Clinical Trial 230289)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy230289.aspx
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| City: |
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Upton |
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State:
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NY |
| Zip Code: |
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11973 |
| Conditions: |
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Obesity |
| Purpose: |
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The purpose of this study is to study the effect on brain function from the combination of
naltrexone SR and bupropion SR on food intake and food craving as examined using Functional
Magnetic Resonance Imaging in overweight or obese subjects.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Right-handed, female subjects, 18 to 45 years of age
- Have body mass index (BMI) ≥ 27 kg/m2 and ≤ 40 kg/m2
- Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to
screening
- On no medications with the exception of oral contraceptives, vitamins, and over the
counter pain, indigestion or allergy medication.
- Normotensive (systolic <140 mm Hg; diastolic <90 mm Hg).
- Negative serum pregnancy test in women of child-bearing potential
- Women of child-bearing potential must be non-lactating, and agree to use acceptable
contraception throughout the study period and for 30 days after discontinuation of
study drug
Exclusion Criteria:
- Obesity of known endocrine or genetic origin (e.g., untreated hypothyroidism,
Cushing's syndrome)
- Inability to participate in fMRI scanning sessions
- History of occupational exposure to metal flakes in their bodies or eyes
- Serious medical condition
- History of alcohol or drug abuse or dependence current or within 2 years prior to
randomization
- History of surgical intervention for obesity
- History of seizures of any etiology or of predisposition to seizures
- Unable to abstain from caffeinated product consumption for at least 48 hours
- Use of drugs, herbs, or dietary supplements believed to significantly affect body
weight or participation in a weight loss management program within one month prior to
randomization |
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| Study is available at: |
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Brookhaven National Laboratory Medical Department
Upton, NY 11973
United States
Primary Contact:
Millard Jayne, RN
Email: mjayne@bnl.gov
Phone: 888-352-7380
Secondary Contact:
Millard Jayne, RN
Email: mjayne@bnl.gov
Phone: 888-352-7380 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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November 16, 2009 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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