A Study Using Functional Magnetic Resonance Imaging (fMRI) to Assess the Effects of Naltrexone SR/ Bupropion SR Therapy in Overweight or Obese Subjects
Information source: Orexigen Therapeutics, Inc
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: naltrexone SR and bupropion SR (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Orexigen Therapeutics, Inc Official(s) and/or principal investigator(s):
Gene-Jack Wang, MD, Principal Investigator, Affiliation: Brookhaven National Laboratory
Overall contact:
Millard Jayne, RN, Phone: 888-352-7380, Email: mjayne@bnl.gov
Summary
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.
Clinical Details
Official title: Naltrexone Sustained-Release (SR) 32 mg and Bupropion Sustained-Release (SR) 360 mg Combination Therapy in Functional Magnetic Resonance Imaging (fMRI ): Changes in Overweight or Obese Subjects
Study design: Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
Primary outcome: To assess brain response to food related cues before and after satiation using functional magnetic resonance imaging.
Secondary outcome: To compare the effect of naltrexone SR plus bupropion SR versus placebo treatment on food craving.
Eligibility
Minimum age: 18 Years.
Maximum age: 45 Years.
Gender(s): Female.
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
Locations and Contacts
Millard Jayne, RN, Phone: 888-352-7380, Email: mjayne@bnl.gov
Brookhaven National Laboratory Medical Department, Upton, New York 11973, United States; Recruiting
Millard Jayne, RN, Phone: 888-352-7380, Email: mjayne@bnl.gov
Additional Information
Starting date: July 2008
Ending date: July 2010
Last updated: September 4, 2008
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