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Trial record 11 of 592 for:    binge eating disorder

Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo

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ClinicalTrials.gov Identifier: NCT02317744
Recruitment Status : Completed
First Posted : December 16, 2014
Results First Posted : December 22, 2017
Last Update Posted : December 22, 2017
Sponsor:
Information provided by (Responsible Party):
Yale University

Brief Summary:
This study will test the effectiveness of the combination of Naltrexone and Bupropion relative to placebo for reducing binge eating in persons with obesity and binge eating disorder.

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Drug: Naltrexone and bupropion combination Other: Pill Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Binge Eating Disorder in Obesity: Naltrexone/ Bupropion Combination Versus Placebo
Study Start Date : December 2014
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Naltrexone/ Bupropion combination
50 mg naltrexone and 300 mg bupropion per day for 3 months
Drug: Naltrexone and bupropion combination
Placebo Comparator: Pill placebo
Daily placebo medication for 3 months
Other: Pill Placebo



Primary Outcome Measures :
  1. Binge Eating Frequency (Continuous) [ Time Frame: Post-treatment (at 3 months) ]
    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).

  2. Binge Eating Frequency (Continuous) [ Time Frame: 6 month follow-up (an average of 6 months following treatment) ]
    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency also is defined continuously (analyzed dimensionally).


Secondary Outcome Measures :
  1. Body Mass Index (BMI) [ Time Frame: Post-treatment (at 3 months) ]
    BMI is calculated using measured height and weight.

  2. Body Mass Index (BMI) [ Time Frame: 6 month follow-up (an average of 6 months following treatment) ]
    BMI is calculated using measured height and weight.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
  • BMI between 30 kg/m2 and 50 kg/m2
  • Not taking anti-depressant medications
  • Read English proficiently enough to read study assessments
  • Available for duration of treatment plus follow-up period
  • Able to travel to study location (New Haven, CT) for monthly visits
  • Agree to study procedures

Exclusion Criteria:

  • Medical status judged by study physician as contraindication
  • History of seizures
  • Past or current anorexia nervosa, bulimia nervosa
  • Current medications that influence eating/weight
  • Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality) that requires immediate treatment
  • Pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02317744


Locations
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United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Carlos M Grilo, Ph.D. Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02317744     History of Changes
Other Study ID Numbers: 1409014705
First Posted: December 16, 2014    Key Record Dates
Results First Posted: December 22, 2017
Last Update Posted: December 22, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
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Disease
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Mental Disorders
Pathologic Processes
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Naltrexone
Bupropion
Bupropion hydrochloride, naltrexone hydrochoride drug combination
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Obesity Agents