Craving, Binge Eating and Obesity - Tabular View

Tracking Information

First Received Date ^ICMJE

December 20, 2006

Last Updated Date

August 6, 2009

Start Date ^ICMJE

December 2005

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Frequency of binge eating episodes

Change History

Complete list of historical versions of study NCT00414167 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Body weight, food cravings, emotional eating

Descriptive Information

Brief Title ^ICMJE

Craving, Binge Eating and Obesity

Official Title ^ICMJE

Placebo-Controlled Trial of Bupropion for the Treatment of Binge Eating Disorder

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.

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 Phase

Phase II, Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Binge Eating Disorder
Obesity

Intervention ^ICMJE

Drug: bupropion
Other: Placebo

Study Arms / Comparison Groups

Experimental: Bupropion
Placebo Comparator: Placebo

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2010

Estimated Primary Completion Date

July 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dr. Marney A White, PhD

203-785-4349

Marney.White@yale.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00414167

Responsible Party

Marney A. White, Ph.D., Yale University School of Medicine

Study ID Numbers ^ICMJE

DK71646

Study Sponsor ^ICMJE

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

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Marney A. White, PhD

Yale University

Information Provided By

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

Verification Date

August 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP