Treatment of Binge Eating in Obese Patients in Primary Care - Tabular View

Tracking Information

First Received Date ^ICMJE

September 27, 2007

Last Updated Date

January 13, 2010

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Binge Eating
BMI

Change History

Complete list of historical versions of study NCT00537810 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Treatment of Binge Eating in Obese Patients in Primary Care

Official Title ^ICMJE

Treatment of Binge Eating in Obese Patients in Primary Care

Brief Summary

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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Placebo Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Factorial Assignment
Masking:  Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose:  Treatment

Condition ^ICMJE

Obesity
Binge Eating

Intervention ^ICMJE

Drug: Sibutramine
15 mg daily

Other Name: Meridia
Drug: Placebo
Daily
Behavioral: Self-help CBT + Sibutramine
Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
Behavioral: Self-help CBT + Placebo
Cognitive behavioral treatment manual for binge eating Placebo daily

Study Arms / Comparison Groups

1: Experimental
Sibutramine 15 mg daily

Intervention: Drug: Sibutramine
2.: Placebo Comparator
Placebo Daily

Intervention: Drug: Placebo
3.: Experimental
Self-help CBT and Placebo Placebo daily, Cognitive behavioral self-help manual for binge eating

Intervention: Behavioral: Self-help CBT + Sibutramine
4: Experimental
Self-help CBT and Sibutramine 15 mg daily Cognitive behavioral treatment manual for binge eating

Intervention: Behavioral: Self-help CBT + 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

150

Completion Date

Estimated Primary Completion Date

September 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 60 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

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

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00537810

Responsible Party

Carlos M. Grilo, PhD/ Principal Investigator, Yale University School of Medicine

Study ID Numbers ^ICMJE

0501027352, R01DK073542-01A1

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators ^ICMJE

Principal Investigator:

Carlos M. Grilo, PhD

Yale University

Information Provided By

Yale University

Verification Date

January 2010

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