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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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

Study Design
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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

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Arms and Interventions
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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


Outcome Measures
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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.


Eligibility Criteria
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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
Contacts and Locations
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02317744    
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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Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Naltrexone
Bupropion
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