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Treatment of Binge Eating in Obese Patients in Primary Care

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Yale University.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Yale University Identifier:
First received: September 27, 2007
Last updated: January 26, 2012
Last verified: January 2012

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.

Condition Intervention Phase
Binge Eating
Drug: Sibutramine
Drug: Placebo
Behavioral: Self-help CBT + Sibutramine
Behavioral: Self-help CBT + Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Binge Eating in Obese Patients in Primary Care

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 150
Study Start Date: September 2007
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Sibutramine 15 mg daily
Drug: Sibutramine
15 mg daily
Other Name: Meridia
Placebo Comparator: 2.
Placebo Daily
Drug: Placebo
Experimental: 3.
Self-help CBT and Placebo Placebo daily, Cognitive behavioral self-help manual for binge eating
Behavioral: Self-help CBT + Sibutramine
Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
Experimental: 4
Self-help CBT and Sibutramine 15 mg daily Cognitive behavioral treatment manual for binge eating
Behavioral: Self-help CBT + Placebo
Cognitive behavioral treatment manual for binge eating Placebo daily


Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00537810

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

United States, Connecticut
Yale Internal Medicine Associates (YIMA) Recruiting
New Haven, Connecticut, United States, 06510
Yale Psychiatric Research at Congress Place Recruiting
New Haven, Connecticut, United States, 06519
Yale-New Haven Hospital (YNHH) Primary Care Center (PCC) Recruiting
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Principal Investigator: Carlos M. Grilo, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University Identifier: NCT00537810     History of Changes
Other Study ID Numbers: 0501027352, R01DK073542-01A1
Study First Received: September 27, 2007
Last Updated: January 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Binge eating
Primary care

Additional relevant MeSH terms:
Binge-Eating Disorder
Body Weight
Eating Disorders
Mental Disorders
Nutrition Disorders
Signs and Symptoms
Signs and Symptoms, Digestive
Anti-Obesity Agents
Antidepressive Agents
Appetite Depressants
Central Nervous System Agents
Pharmacologic Actions
Psychotropic Drugs
Therapeutic Uses processed this record on November 20, 2014