A Study Using Functional Magnetic Resonance Imaging (fMRI) to Assess the Effects of Naltrexone SR/ Bupropion SR Therapy in Overweight or Obese Subjects

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”

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.

Intervention(s) in this Clinical Trial

• Drug: naltrexone SR and bupropion SR
  • A screening period of up to 30 days followed by a 4 week blinded assigned treatment (tablets) period administered in a weekly titrated dose escalation.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day
• Placebo Comparator: 2
  • matching placebo tablets

Primary Measures

• To assess brain response to food related cues before and after satiation using functional magnetic resonance imaging.
  • Time Frame: Baseline compared to Week 4
    Safety Issue?: No

Secondary Measures

• To compare the effect of naltrexone SR plus bupropion SR versus placebo treatment on food craving.
  • Time Frame: baseline to week 4
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Orexigen Therapeutics, Inc Industry

Overall Clinical Trial Officials and Contacts

Gene-Jack Wang, MD Principal Investigator Brookhaven National Laboratory  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00711477

Study ID Number: NB-431

ClinicalTrials.gov Identifier: NCT00711477

Health Authority: United States: Food and Drug Administration