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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)



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City:  Upton
State:  
NY
Zip Code: 11973
Conditions: Obesity
Purpose: 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.
Study summary:
Criteria: 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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Data Source: ClinicalTrials.gov
Date Processed: October 7, 2010
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