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ObesityPhase 2NCT00711477

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

A Phase 2 study testing Naltrexone SR 32 mg/bupropion SR 360 mg/day and fMRI scan in people with Obesity, run by Orexigen Therapeutics, Inc at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 45 years, women only
Conditions the study is for
Obesity
What is being tested?
Naltrexone SR 32 mg/bupropion SR 360 mg/day and fMRI scan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
1 siteUnited States
Study dates
Sep 2008to Jun 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brookhaven National Laboratory Medical Department

    Upton, New York, 11973

Other trials in United States

About this study

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 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.

Conditions
Obesity
Being tested
Naltrexone SR 32 mg/bupropion SR 360 mg/day, Placebo, fMRI scan
Keywords
obesity, overweight, magnetic resonance imaging, naltrexone, bupropion
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naltrexone SR 32 mg/bupropion SR 360 mg/dayDrug

  • PlaceboDrug

  • fMRI scanOther

    Also called functional magnetic resonance imaging to assess the effects of the drug/placebo on areas of the brain

    fMRI to assess the effects of the drug/placebo on areas of the brain

Study groups in NCT00711477
Study groupRoleWhat they receive
NB32ExperimentalNaltrexone SR 32 mg/bupropion SR 360 mg/day
Receives: Drug: Naltrexone SR 32 mg/bupropion SR 360 mg/day; Other: fMRI scan
PlaceboPlacebo comparatorPlacebo tablets
Receives: Drug: Placebo; Other: fMRI scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Frontal

    Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.

    Measured: Baseline, 4 weeks

  2. Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Anterior Cingulate

    Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.

    Measured: Baseline, 4 weeks

  3. Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 1

    Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.

    Measured: Baseline, 4 weeks

  4. Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Hippocampal Region 2

    Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.

    Measured: Baseline, 4 weeks

  5. Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Parietal

    Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.

    Measured: Baseline, 4 weeks

  6. Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Posterior Insula

    Assessment of differences in brain activation in response to food cues before and after 4 weeks of treatment in subjects receiving NB or placebo.

    Measured: Baseline, 4 weeks

Secondary outcomes (6)

  1. Percent Change in Body Weight

    Measured: Baseline, 4 weeks

  2. Dutch Eating Behavior Questionnaire - Change in Restrained Eating Subscale Score

    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).

    Measured: Baseline, 4 weeks

  3. Dutch Eating Behavior Questionnaire - Change in Emotional Eating A Subscale Score

    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).

    Measured: Baseline, 4 weeks

  4. Dutch Eating Behavior Questionnaire - Change in Emotional Eating B Subscale Score

    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).

    Measured: Baseline, 4 weeks

  5. Dutch Eating Behavior Questionnaire - Change in External Eating Subscale Score

    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).

    Measured: Baseline, 4 weeks

  6. Change in Question 19 From 21-Item COE (Control of Eating) Questionnaire

    Question 19: Generally, how difficult has it been to control your eating? Scoring: 0=not at all difficult; 100=extremely difficult

    Measured: Baseline, 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2008 (estimated)
  2. Study startSep 2008
  3. Primary completionJun 2010
  4. Study completionJun 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00711477
Sponsor's protocol ID
NB-431
Status last verified
Dec 2014
First submitted
3 Jul 2008
Last updated
6 Jan 2015
Data monitoring committee
No

Publications

  • Wang GJ, Tomasi D, Volkow ND, Wang R, Telang F, Caparelli EC, Dunayevich E. Effect of combined naltrexone and bupropion therapy on the brain's reactivity to food cues. Int J Obes (Lond). 2014 May;38(5):682-8. doi: 10.1038/ijo.2013.145. Epub 2013 Aug 8.

    PubMed 23924756

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naltrexone SR 32 mg/bupropion SR 360 mg/day and fMRI scan in people with Obesity, run by Orexigen Therapeutics, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response to Food Related Cues Using Functional Magnetic Resonance Imaging - Superior Frontal (time frame: Baseline, 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00711477, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2015.

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