Craving, Binge Eating and Obesity

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00414167
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
• Enrollment: 61
• Location: 1
• Arms: 2
• Duration (Months): 62.9
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Binge Eating Disorder; Obesity	Drug: bupropion; Other: Placebo	Phase 2/Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• 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
• Study Start Date: Dec 1, 2005
• Actual Primary Completion Date: Mar 1, 2011
• Actual Study Completion Date: Mar 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Bupropion	Drug: bupropion; 300 mg per day for 8 weeks; Other Names: wellbutrin zyban
Placebo Comparator: 2 Placebo	Other: Placebo; Placebo

Outcome Measures

Primary Outcome Measures

1. Frequency of Binge Eating Episodes [One week (at post treatment)]

Secondary Outcome Measures

1. Percent BMI Loss [8 weeks (baseline and 8 weeks)]

   Percent loss in Body Mass Index

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Yale University School of Medicine	New Haven	Connecticut	United States	06520

Sponsors and Collaborators

• Yale University
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Marney A. White, PhD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00414167
• Other Study ID Numbers: 0511000832; K23DK071646
• First Posted: Dec 21, 2006
• Last Update Posted: Apr 3, 2020
• Last Verified: Apr 1, 2020

• Keywords provided by Yale University: Binge eating; Obesity; Medication; Craving; Emotional eating
• Additional relevant MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder; Bupropion

Study Results

Participant Flow

Recruitment Details	Sixty-one overweight and obese women with BED were recruited from the community via advertisements. Participants were enrolled from November 2006 to December 2010. Assessments and clinic appointments were held in a medical school research clinic.

Arm/Group Title	Bupropion (300 mg/d)	Placebo
Arm/Group Description	Bupropion bupropion : 300 mg per day for 8 weeks	Placebo Placebo : Placebo
Period Title: Overall Study
STARTED	31	30
COMPLETED	27	27
NOT COMPLETED	4	3

Baseline Characteristics

Arm/Group Title	Bupropion	Placebo	Total
Arm/Group Description	Bupropion bupropion : 300 mg per day for 8 weeks	Placebo Placebo : Placebo	Total of all reporting groups
Overall Participants	31	30	61
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	31 100%	30 100%	61 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.2 (12.1)	43.1 (13.0)	44.2 (12.5)
Sex: Female, Male (Count of Participants)
Female	31 100%	30 100%	61 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Frequency of Binge Eating Episodes
Time Frame	One week (at post treatment)

Outcome Measure Data

Analysis Population Description

Baseline forward imputation for missing data.

Arm/Group Title	Bupropion	Placebo
Arm/Group Description
Measure Participants	31	30
Mean (Standard Deviation) [episodes/week]	0.8 (1.2)	1.0 (1.5)

2. Secondary Outcome

Title	Percent BMI Loss
Description	Percent loss in Body Mass Index
Time Frame	8 weeks (baseline and 8 weeks)

Outcome Measure Data

Analysis Population Description

Baseline values imputed forward for missing data.

Arm/Group Title	Bupropion	Placebo
Arm/Group Description	Bupropion bupropion : 300 mg per day for 8 weeks	Placebo Placebo : Placebo
Measure Participants	31	20
Mean (Standard Deviation) [Percent loss]	1.8 (2.6)	0.6 (2.1)

Adverse Events

Arm/Group Title	Bupropion		Placebo
Arm/Group Description
All Cause Mortality
	Bupropion		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Bupropion		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Bupropion		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.