- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00711477
A Study Using Functional Magnetic Resonance Imaging (fMRI) to Assess the Effects of Naltrexone SR/ Bupropion SR Therapy in Overweight or Obese Subjects
January 5, 2015 updated by: Orexigen Therapeutics, Inc
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 was to assess the effect of naltrexone SR/bupropion SR (NB) on brain function in response to food cues using functional magnetic resonance imaging in overweight or obese subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
46
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
Upton, New York, United States, 11973
- Brookhaven National Laboratory Medical Department
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Right-handed, female subjects, 18 to 45 years of age
- Body mass index (BMI) ≥ 27 and ≤ 40 kg/m²
- Free from clinically significant illness or disease as determined by medical history and physical examination
- Able to provide proof of identity during the enrollment process
- In good general health, without clinically significant medical history, physical examination findings or laboratory results
- Laboratory values obtained within 30 days of study entry within normal range for healthy volunteers.
- Normal urinalysis on initial screening day defined as: negative glucose, negative or trace protein, and negative or trace hemoglobin
- Normotensive (systolic ≤140 mm Hg, diastolic ≤90 mm hg)
- On no concomitant medications with the exception of oral contraceptives, vitamins, and over the counter pain, indigestion or allergy medication
- All women of child bearing potential must be non-lactating, must have a negative STAT pregnancy test, and agree to use effective contraception methods throughout study period and for 30 days after discontinuation of study drug. The following are considered effective methods of contraception: Combination or progestin-only birth control pills (oral contraceptives), vaginal contraceptive rings, contraceptive patches, Depo Provera, intrauterine devices, barrier methods with spermicide (condom/foam, diaphragm/ spermicide), abstinence. (Subjects who have had a tubal ligation, hysterectomy or are post-menopausal for 2 years are considered NOT to be of child bearing potential)
- For women not using hormonal methods of contraception, should be in the follicular phase of the menstrual cycle at the baseline visit.
- Non-smoker and no use of tobacco or nicotine products for at least 6 months prior to baseline. On screening and study days, we will test the subjects' urine for presence of nicotinine/cotinine (STAT) test as confirmatory evidence of being a non-smoker in addition to their self-report. A Tobacco Questionnaire and Breath CO will also be administered for eligibility on the day of screening for confirmation purposes.
- No clinically significant abnormality on ECG, baseline QTc <470
- Able to comply with all required study procedures
- Available for follow up for the duration of the study
- Willing and able to give written informed consent
Exclusion Criteria:
- Obesity of known endocrine or genetic origin (e.g., untreated hypothyroidism, Cushing's syndrome, Prader Willi Syndrome, established Polycystic Ovary Syndrome)
- Inability to participate in fMRI scanning sessions
- History of occupational exposure to metal flakes in their bodies or eyes.
- History of known indwelling ferromagnetic metals or fragments.
- History of acute or chronic illness that requires medical therapy including active gastrointestinal conditions that might interfere with drug absorption
- History or presence of hepatic, renal, cardiovascular or gastrointestinal diseases
- Type I or Type II diabetes mellitus requiring pharmacotherapy
- Active malignancy or history of malignancy (other than non-melanoma skin cancer or surgically cured cervical cancer) within 5 years of enrollment
- Serious psychiatric illness, including lifetime history of psychiatric hospitalization, suicide attempt, bipolar disorder, schizophrenia or other psychosis, bulimia, or anorexia nervosa; current serious personality disorder, (e.g. borderline or antisocial), major depressive disorder within the previous two years, suicidal ideation or need for psychiatric treatment in the previous 6 months.
- In need of medications for the treatment of a psychiatric disorder within the previous 6 months prior to randomization.
- IDS-SR total score >25 or scores >1 in items 5 (sadness), 6 (irritability), 7 (anxiety/tension) or 18 (suicidality)
- History of alcohol or drug abuse, current or within 2 years
- Unable to abstain from caffeinated product consumption for at least 48 hours
- History of surgical intervention for obesity
- 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.
- History of hypersensitivity to bupropion or naltrexone
- History of seizure disorder or predisposition to seizures (e.g., history of cerebrovascular accident, brain surgery, head trauma with ≥5 minutes loss of consciousness, concussion symptoms lasting ≥ 15 minutes, skull fracture, subdural hematoma, or febrile seizures) or need for therapy with anticonvulsant medication.
- History of treatment with bupropion or naltrexone within 12 months
- Positive urine drug screen - STAT test performed on each day of study.
- Pregnant or breast-feeding
- Planned surgical procedure or trip that can impact the conduct of the study
- Use of investigational drug, device or procedure within 30 days
- Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
- Participation in any previous clinical trial sponsored by Orexigen Therapeutics.
- Study personnel, sponsor representatives and their immediate families.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Placebo tablets
|
fMRI to assess the effects of the drug/placebo on areas of the brain
Other Names:
|
Experimental: NB32
Naltrexone SR 32 mg/bupropion SR 360 mg/day
|
fMRI to assess the effects of the drug/placebo on areas of the brain
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Frontal
Time Frame: Baseline, 4 weeks
|
Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.
|
Baseline, 4 weeks
|
Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Anterior Cingulate
Time Frame: Baseline, 4 weeks
|
Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.
|
Baseline, 4 weeks
|
Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 1
Time Frame: Baseline, 4 weeks
|
Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.
|
Baseline, 4 weeks
|
Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 2
Time Frame: Baseline, 4 weeks
|
Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.
|
Baseline, 4 weeks
|
Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Parietal
Time Frame: Baseline, 4 weeks
|
Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.
|
Baseline, 4 weeks
|
Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Posterior Insula
Time Frame: Baseline, 4 weeks
|
Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.
|
Baseline, 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent Change in Body Weight
Time Frame: Baseline, 4 weeks
|
Baseline, 4 weeks
|
|
Dutch Eating Behavior Questionnaire - Change in Restrained Eating Subscale Score
Time Frame: Baseline, 4 weeks
|
The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating).
Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often.
The Restrained Eating subscale consisted of 10 items and the scores ranged from 10 (worse outcome) to 50 (better outcome).
|
Baseline, 4 weeks
|
Dutch Eating Behavior Questionnaire - Change in Emotional Eating A Subscale Score
Time Frame: Baseline, 4 weeks
|
The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating).
Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often.
The Emotional Eating A subscale (clearly labeled emotions) consisted of 9 items and the scores ranged from 9 (better outcome) to 45 (worse outcome).
|
Baseline, 4 weeks
|
Dutch Eating Behavior Questionnaire - Change in Emotional Eating B Subscale Score
Time Frame: Baseline, 4 weeks
|
The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating).
Subjects rated the frequency of their eating behaviors using a 5-point scale, where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often.
The Emotional Eating B subscale (diffuse emotions) consisted of 4 items and the scores ranged from 4 (better outcome) to 20 (worse outcome).
|
Baseline, 4 weeks
|
Dutch Eating Behavior Questionnaire - Change in External Eating Subscale Score
Time Frame: Baseline, 4 weeks
|
The Dutch Eating Behavior Questionnaire is a 33-item self-report measure designed to assess the type of eating behavior and is organized into 3 subscales (emotional eating, externally-induced eating, and restrained eating).
Subjects rated the frequency of their eating behaviors using a 5-point scale where 1=never, 2=seldom, 3=sometimes, 4=often, and 5=very often.
The External Eating subscale consisted of 10 items and the scores ranged from 10 (better outcome) to 50 (worse outcome).
|
Baseline, 4 weeks
|
Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire
Time Frame: Baseline, 4 weeks
|
Question 19: Generally, how difficult has it been to control your eating?
Scoring: 0=not at all difficult; 100=extremely difficult
|
Baseline, 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gene-Jack Wang, MD, Brookhaven National Laboratory
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
June 1, 2010
Study Completion (Actual)
June 1, 2010
Study Registration Dates
First Submitted
July 3, 2008
First Submitted That Met QC Criteria
July 3, 2008
First Posted (Estimate)
July 9, 2008
Study Record Updates
Last Update Posted (Estimate)
January 6, 2015
Last Update Submitted That Met QC Criteria
January 5, 2015
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Body Weight
- Overweight
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Psychotropic Drugs
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Antidepressive Agents
- Dopamine Agents
- Narcotic Antagonists
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Alcohol Deterrents
- Dopamine Uptake Inhibitors
- Naltrexone
- Bupropion
Other Study ID Numbers
- NB-431
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Obesity
-
Central Hospital, Nancy, FranceNot yet recruiting
-
University of MinnesotaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruitingAdolescent ObesityUnited States
-
Helsinki University Central HospitalKarolinska Institutet; Folkhälsan Researech CenterEnrolling by invitation
-
Istanbul Medipol University HospitalMedipol UniversityCompletedObesity, Morbid | Obesity, Adolescent | Obesity, Abdominal | Weight, Body | Obesity, VisceralTurkey
-
Queen Fabiola Children's University HospitalNot yet recruitingMorbid Obesity | Adolescent Obesity | Bariatric SurgeryBelgium
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; Pennington Biomedical Research... and other collaboratorsActive, not recruitingOvernutrition | Nutrition Disorders | Overweight | Body Weight | Pediatric Obesity | Body Weight Changes | Childhood Obesity | Weight Gain | Adolescent Obesity | Obesity, Childhood | Overweight and Obesity | Overweight or Obesity | Overweight AdolescentsUnited States
-
Azienda Ospedaliero-Universitaria Consorziale Policlinico...Institute of Biomembranes, Bioenergetics and Molecular Biotechnologies; Istituti... and other collaboratorsCompletedMorbid Obesity | Metabolically Healthy ObesityItaly
-
The Hospital for Sick ChildrenCompleted
-
Ihuoma EneliCompletedObesity, ChildhoodUnited States
-
Fundació Sant Joan de DéuNot yet recruitingObesity, Childhood | Obesity, AdolescentSpain
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States