Treatment of Binge Eating in Obese Patients in Primary Care

Condition(s) targeted: Obesity; Binge Eating

Intervention: Sibutramine (Drug); Placebo (Drug); Self-help CBT + Sibutramine (Behavioral); Self-help CBT + Placebo (Behavioral)

Phase: Phase 4

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Carlos M. Grilo, PhD, Principal Investigator, Affiliation: Yale University

Overall contact:
Shannon Zaitsoff, Ph.D., Phone: 203-785-6395

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.

Official title: Treatment of Binge Eating in Obese Patients in Primary Care

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study

Primary outcome:

Binge Eating

BMI

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Shannon Zaitsoff, Ph.D., Phone: 203-785-6395

Yale-New Haven Hospital (YNHH) Primary Care Center (PCC), New Haven, Connecticut 06510, United States; Recruiting

Yale Internal Medicine Associates (YIMA), New Haven, Connecticut 06510, United States; Recruiting

Yale Psychiatric Research at Congress Place, New Haven, Connecticut 06519, United States; Recruiting

Starting date: September 2007
Last updated: April 24, 2008