Treatment of Binge Eating in Obese Patients in Primary Care

Obesity Clinical Trial

Official title:

Treatment of Binge Eating in Obese Patients in Primary Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537810
• Other study ID #: 0501027352
• Secondary ID: R01DK073542-01A1
• Status: Completed
• Phase: Phase 4
• Start date: September 2007
• Est. completion date: October 2012

Study information

• Verified date: August 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Binge Eating
• Binge-Eating Disorder
• Bulimia
• Obesity

Intervention

Drug:
• Sibutramine
15 mg daily
• Placebo
Daily

Behavioral:
• Self-help CBT + Sibutramine
Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
• Self-help CBT + Placebo
Cognitive behavioral treatment manual for binge eating Placebo daily

Locations

Country	Name	City	State
United States	Yale Internal Medicine Associates (YIMA)	New Haven	Connecticut
United States	Yale Psychiatric Research at Congress Place	New Haven	Connecticut
United States	Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)	New Haven	Connecticut

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Grilo CM, Masheb RM, White MA, Gueorguieva R, Barnes RD, Walsh BT, McKenzie KC, Genao I, Garcia R. Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: randomized placebo-controlled clinical trial of self-h — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Binge Eating (Remission)	Remission from binge eating (zero binge episodes during previous 28 days)	4 months treatment; 6 and 12 month follow up post treatment
Primary	BMI	BMI (kg/m^2) was measured 4 months after treatment.	4 months