Treatment of Binge Eating in Obese Patients in Primary Care

Phase 4

Completed

• Conditions: Binge Eating; Obesity
• Interventions: Drug: Placebo; Behavioral: Self-help CBT + Sibutramine; Behavioral: Self-help CBT + Placebo; Drug: Sibutramine

• Registration Number: NCT00537810
• Lead Sponsor: Yale University

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

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-09-27
• Study First Submitted QC: 2007-09-30
• Study First Posted: 2007-10-01
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Results First Submitted: 2014-06-19
• Results First Submitted QC: 2014-12-11
• Results First Posted: 2014-12-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo Daily
Placebo/CBTsh	Self-help CBT + Sibutramine	Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
Sibutramine/CBTsh	Self-help CBT + Placebo	Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Sibutramine	Sibutramine	Sibutramine 15 mg daily

Primary Outcome Measures

Name	Time	Method
BMI	4 months	BMI (kg/m\^2) was measured 4 months after treatment.
Binge Eating (Remission)	4 months treatment; 6 and 12 month follow up post treatment	Remission from binge eating (zero binge episodes during previous 28 days)

Trial Locations

Locations (3)

Yale-New Haven Hospital (YNHH) Primary Care Center (PCC); 🇺🇸 New Haven, Connecticut, United States

Yale Internal Medicine Associates (YIMA); 🇺🇸 New Haven, Connecticut, United States

Yale Psychiatric Research at Congress Place; 🇺🇸 New Haven, Connecticut, United States