Treatment of Binge Eating in Obese Patients in Primary Care

Yale University

Status and phase: Completed; Phase 4

Conditions: Binge Eating; Obesity

Treatments: Behavioral: Self-help CBT + Sibutramine; Drug: Sibutramine; Behavioral: Self-help CBT + Placebo; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00537810

0501027352

R01DK073542-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 104 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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104 participants in 4 patient groups, including a placebo group

Sibutramine

Experimental group

Description:

Sibutramine 15 mg daily

Treatment:

Drug: Sibutramine

Placebo

Placebo Comparator group

Description:

Placebo Daily

Treatment:

Drug: Placebo

Placebo/CBTsh

Experimental group

Description:

Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating

Treatment:

Behavioral: Self-help CBT + Sibutramine

Sibutramine/CBTsh

Experimental group

Description:

Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating

Treatment:

Behavioral: Self-help CBT + Placebo