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Craving, Binge Eating and Obesity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00414167
First Posted: December 21, 2006
Last Update Posted: March 28, 2014
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.
Information provided by (Responsible Party):
Marney A. White, Yale University
  Purpose

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 Intervention Phase
Binge Eating Disorder Obesity Drug: bupropion Other: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Marney A. White, Yale University:

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

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


Enrollment: 61
Study Start Date: December 2005
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Bupropion
Drug: bupropion
300 mg per day for 8 weeks
Other Names:
  • wellbutrin
  • zyban
Placebo Comparator: 2
Placebo
Other: Placebo
Placebo

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (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
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
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Marney A. White, PhD Yale University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marney A. White, Associate Professor of Psychiatry, Yale University
ClinicalTrials.gov Identifier: NCT00414167     History of Changes
Other Study ID Numbers: K23DK071646 ( U.S. NIH Grant/Contract )
First Submitted: December 20, 2006
First Posted: December 21, 2006
Results First Submitted: October 22, 2012
Results First Posted: March 28, 2014
Last Update Posted: March 28, 2014
Last Verified: February 2014

Keywords provided by Marney A. White, Yale University:
Binge eating
Obesity
Medication
Craving
Emotional eating

Additional relevant MeSH terms:
Obesity
Feeding and Eating Disorders
Binge-Eating Disorder
Bulimia
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
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