Treatment of Binge Eating in Obese Patients in Primary Care

This study is currently recruiting participants.

Verified by Yale University, January 2010

First Received: September 27, 2007 Last Updated: January 13, 2010 History of Changes

Sponsor:	Yale University
Collaborators:	National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00537810

Purpose

This study will test the effectiveness of two empirically-supported but distinct treatments for recurrent binge eating in obese patients: 1) Cognitive Behavior Therapy, using a pure self-help approach and 2) sibutramine, an anti-obesity medication also found to have efficacy for binge eating. Self-help Cognitive Behavior Therapy and sibutramine will be administered alone and in combination in a primary care setting.

Condition	Intervention	Phase
Obesity Binge Eating	Drug: Sibutramine Drug: Placebo Behavioral: Self-help CBT + Sibutramine Behavioral: Self-help CBT + Placebo	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Official Title:	Treatment of Binge Eating in Obese Patients in Primary Care

Resource links provided by NLM:

MedlinePlus related topics: Obesity

Drug Information available for: Sibutramine Sibutramine hydrochloride monohydrate

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Binge Eating [ Time Frame: 6 months treatment; 6 and 12 month follow up post treatment ] [ Designated as safety issue: No ]
BMI [ Time Frame: 6 months treatment; 6 and 12 month follow up post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	September 2007
Estimated Primary Completion Date:	September 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Sibutramine 15 mg daily	Drug: Sibutramine 15 mg daily
2.: Placebo Comparator Placebo Daily	Drug: Placebo Daily
3.: Experimental Self-help CBT and Placebo Placebo daily, Cognitive behavioral self-help manual for binge eating	Behavioral: Self-help CBT + Sibutramine Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
4: Experimental Self-help CBT and Sibutramine 15 mg daily Cognitive behavioral treatment manual for binge eating	Behavioral: Self-help CBT + Placebo Cognitive behavioral treatment manual for binge eating Placebo daily

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Obese (BMI >= 30)

Exclusion Criteria:

Medication regimen that represents medical contraindication to sibutramine
Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537810

Contacts

Contact: Rachel Barnes, Ph.D.	203-785-6395
Contact: Megan Roehrig, Ph.D.	203-785-6040

Locations

United States, Connecticut
Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)	Recruiting
New Haven, Connecticut, United States, 06510
Yale Internal Medicine Associates (YIMA)	Recruiting
New Haven, Connecticut, United States, 06510
Yale Psychiatric Research at Congress Place	Recruiting
New Haven, Connecticut, United States, 06519

Sponsors and Collaborators

Yale University

National Institutes of Health (NIH)

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

Investigators

Principal Investigator:

Carlos M. Grilo, PhD

Yale University

More Information

No publications provided

Responsible Party:	Yale University School of Medicine ( Carlos M. Grilo, PhD/ Principal Investigator )
Study ID Numbers:	0501027352, R01DK073542-01A1
Study First Received:	September 27, 2007
Last Updated:	January 13, 2010
ClinicalTrials.gov Identifier:	NCT00537810 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Obesity
Binge eating
Sibutramine
Self-help
Primary care

Additional relevant MeSH terms:

Obesity
Signs and Symptoms, Digestive
Psychotropic Drugs
Overweight
Pharmacologic Actions
Hyperphagia
Body Weight
Sibutramine
Anti-Obesity Agents
Bulimia Nervosa

Signs and Symptoms
Mental Disorders
Therapeutic Uses
Bulimia
Appetite Depressants
Nutrition Disorders
Overnutrition
Central Nervous System Agents
Antidepressive Agents
Eating Disorders

ClinicalTrials.gov processed this record on February 08, 2010