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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00711477
First received: July 3, 2008
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  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.


Condition Intervention Phase
Obesity
 Drug: naltrexone SR and bupropion SR
Drug: Placebo
Other: fMRI scan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans Obesity
U.S. FDA Resources

Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the effect of naltrexone SR plus bupropion SR versus placebo treatment on food craving. [ Time Frame: baseline to week 4 ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: July 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NB32
Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day (drugs are combined in same tablet)
 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.
Other: fMRI scan
fMRI to assess the effects of the drug/placebo on areas of the brain
Other Name: functional magnetic resonance imaging to assess the effects of the drug/placebo on areas of the brain
Placebo Comparator: Placebo
matching placebo tablets
 Drug: Placebo
placebo tablets (matched to look like active)
Other: fMRI scan
fMRI to assess the effects of the drug/placebo on areas of the brain
Other Name: functional magnetic resonance imaging to assess the effects of the drug/placebo on areas of the brain

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00711477

Locations
United States, New York
Brookhaven National Laboratory Medical Department
Upton, New York, United States, 11973
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
Principal Investigator: Gene-Jack Wang, MD Brookhaven National Laboratory
  More Information

No publications provided

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00711477     History of Changes
Other Study ID Numbers: NB-431
Study First Received: July 3, 2008
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
obesity
overweight
magnetic resonance imaging
naltrexone
bupropion

Additional relevant MeSH terms:
Obesity
Overweight
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms
Naltrexone
Bupropion
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
 Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013