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Craving, Binge Eating and Obesity

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: NCT00414167
Recruitment Status : Completed
First Posted : December 21, 2006
Results First Posted : March 28, 2014
Last Update Posted : April 3, 2020
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:

This research study is designed to look at the effectiveness of bupropion for reducing binge eating in overweight persons with binge eating problems. Participants in the study will receive either bupropion or placebo ("sugar" pill, inactive medication) as an outpatient for eight weeks. In addition, participants will be given the option to receive 8 weeks of free behavioral weight loss treatment. This treatment, known to be effective for reducing binge eating and helping people lose weight, will be administered following the medication phase and at no cost.

It is expected that compared to placebo, bupropion will produce greater reductions in binge eating.


Condition or disease Intervention/treatment Phase
Binge Eating Disorder Obesity Drug: bupropion Other: Placebo Phase 2 Phase 3

Detailed Description:
The proposed study is an 8-week randomized placebo-controlled trial to test the efficacy of bupropion in treating overweight women with binge eating disorder (BED). Bupropion is an antidepressant that has demonstrated efficacy in smoking cessation and some efficacy in obesity treatment. Since cravings and depressed mood are hypothesized to contribute to binge eating episodes, bupropion is a promising psychopharmacological agent in treating binge eating and reducing weight. It is hypothesized that compared to placebo, bupropion will produce significantly greater reductions in the frequency of binge eating. Secondary goals are to explore interrelationships between treatment and changes in cravings, frequency of binge episodes, emotional eating, and weight loss. Following the medication phase of the trial, all patients will be offered 8 weeks of behavioral weight loss treatment administered by doctoral-level psychologists specializing in eating disorders and weight management.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Placebo-Controlled Trial of Bupropion for the Treatment of Binge Eating Disorder
Study Start Date : December 2005
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1
Bupropion
 Drug: bupropion
300 mg per day for 8 weeks
Other Names:
  • wellbutrin
  • zyban
Placebo Comparator: 2
Placebo
 Other: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Frequency of Binge Eating Episodes [ Time Frame: One week (at post treatment) ]

Secondary Outcome Measures :
  1. Percent BMI Loss [ Time Frame: 8 weeks (baseline and 8 weeks) ]
    Percent loss in Body Mass Index


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • BMI 25-50
  • Able to travel to clinical site (New Haven, CT) for bi-weekly visits.

Exclusion Criteria:

  • Predisposition to seizures
  • History of anorexia or bulimia nervosa
  • Current Type I or Type II diabetes mellitus
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): NCT00414167


Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Marney A. White, PhD 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: NCT00414167    
Other Study ID Numbers: 0511000832
K23DK071646 ( U.S. NIH Grant/Contract )
First Posted: December 21, 2006    Key Record Dates
Results First Posted: March 28, 2014
Last Update Posted: April 3, 2020
Last Verified: April 2020
Keywords provided by Yale University:
Binge eating
Obesity
Medication
Craving
Emotional eating
Additional relevant MeSH terms:
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Obesity
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Bupropion
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
Physiological Effects of Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors