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 is currently recruiting participants.

Verified by Orexigen Therapeutics, Inc, September 2008

First Received: July 3, 2008 Last Updated: September 4, 2008 History of Changes

Sponsor:	Orexigen Therapeutics, Inc
Information provided by:	Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00711477

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	Phase II

Study Type:	Interventional
Study Design:	Basic Science, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment
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

Drug Information available for: Naltrexone Naltrexone hydrochloride Bupropion hydrochloride Bupropion

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 ]

Estimated Enrollment:	40
Study Start Date:	July 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Naltrexone SR 32 mg/day plus bupropion SR 360 mg/day	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.
2: Placebo Comparator matching placebo tablets	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.

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

Contacts

Contact: Millard Jayne, RN

888-352-7380

mjayne@bnl.gov

Locations

United States, New York
Brookhaven National Laboratory Medical Department	Recruiting
Upton, New York, United States, 11973
Contact: Millard Jayne, RN 888-352-7380 mjayne@bnl.gov

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 ( Eduardo Dunayevich, MD/ Cheif Medical Officer )
Study ID Numbers:	NB-431
Study First Received:	July 3, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00711477 History of Changes
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:

Dopamine Uptake Inhibitors
Obesity
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Physiological Effects of Drugs
Psychotropic Drugs
Overweight
Pharmacologic Actions
Body Weight
Signs and Symptoms

Sensory System Agents
Therapeutic Uses
Naltrexone
Bupropion
Nutrition Disorders
Dopamine Agents
Overnutrition
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on February 08, 2010