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Craving, Binge Eating and Obesity

Primary Purpose

Binge Eating Disorder, Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bupropion
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder focused on measuring Binge eating, Obesity, Medication, Craving, Emotional eating

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Bupropion

Placebo

Outcomes

Primary Outcome Measures

Frequency of Binge Eating Episodes

Secondary Outcome Measures

Percent BMI Loss
Percent loss in Body Mass Index

Full Information

First Posted
December 20, 2006
Last Updated
April 1, 2020
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00414167
Brief Title
Craving, Binge Eating and Obesity
Official Title
Placebo-Controlled Trial of Bupropion for the Treatment of Binge Eating Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder, Obesity
Keywords
Binge eating, Obesity, Medication, Craving, Emotional eating

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Bupropion
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
bupropion
Other Intervention Name(s)
wellbutrin, zyban
Intervention Description
300 mg per day for 8 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Frequency of Binge Eating Episodes
Time Frame
One week (at post treatment)
Secondary Outcome Measure Information:
Title
Percent BMI Loss
Description
Percent loss in Body Mass Index
Time Frame
8 weeks (baseline and 8 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marney A. White, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23656848
Citation
White MA, Grilo CM. Bupropion for overweight women with binge-eating disorder: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2013 Apr;74(4):400-6. doi: 10.4088/JCP.12m08071.
Results Reference
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Craving, Binge Eating and Obesity

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