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Craving, Binge Eating and Obesity

This study is currently recruiting participants.
Verified by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), August 2008

Sponsored by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT00414167
  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 II
Phase III

MedlinePlus related topics:   Eating Disorders    Obesity   

Drug Information available for:   Bupropion hydrochloride    Bupropion   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Placebo-Controlled Trial of Bupropion for the Treatment of Binge Eating Disorder

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • Frequency of binge eating episodes [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body weight, food cravings, emotional eating [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   42
Study Start Date:   December 2005
Estimated Study Completion Date:   December 2009
Estimated Primary Completion Date:   December 2009 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Bupropion
Drug: bupropion
300 mg per day for 8 weeks
2: Placebo Comparator
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
Ages Eligible for Study:   18 Years to 65 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414167

Contacts
Contact: Dr. Marney A White, PhD     203-785-4349     Marney.White@yale.edu    

Locations
United States, Connecticut
Yale University School of Medicine     Recruiting
      New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Investigators
Principal Investigator:     Marney A. White, PhD     Yale University    
  More Information


Responsible Party:   Yale University School of Medicine ( Marney A. White, Ph.D. )
Study ID Numbers:   DK71646
First Received:   December 20, 2006
Last Updated:   August 8, 2008
ClinicalTrials.gov Identifier:   NCT00414167
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Binge eating  
Obesity  
Medication  
Craving  
Emotional eating  

Study placed in the following topic categories:
Obesity
Signs and Symptoms, Digestive
Overweight
Hyperphagia
Body Weight
Bulimia Nervosa
Signs and Symptoms
Dopamine
Mental Disorders
Bulimia
Bupropion
Nutrition Disorders
Overnutrition
Eating Disorders

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Pathologic Processes
Therapeutic Uses
Dopamine Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2008




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