Craving, Binge Eating and Obesity - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders Obesity

Drug Information available for: Bupropion hydrochloride Bupropion

U.S. FDA Resources

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:	July 2010
Estimated Primary Completion Date:	July 2010 (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

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

Marney A. White, PhD

Yale University

More Information

No publications provided

Responsible Party:	Yale University School of Medicine ( Marney A. White, Ph.D. )
Study ID Numbers:	DK71646
Study First Received:	December 20, 2006
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00414167 History of Changes
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

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Overweight
Hyperphagia
Body Weight
Signs and Symptoms
Bulimia Nervosa
Pathologic Processes
Mental Disorders

Therapeutic Uses
Nutrition Disorders
Antidepressive Agents, Second-Generation
Eating Disorders
Antidepressive Agents
Obesity
Disease
Pharmacologic Actions
Bulimia
Bupropion
Overnutrition
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009