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Treatment of Binge Eating in Obese Patients in Primary Care

This study is currently recruiting participants.
Verified January 2012 by Yale University
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00537810
First received: September 27, 2007
Last updated: January 26, 2012
Last verified: January 2012
History of Changes
  Purpose

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
Obesity
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:

MedlinePlus related topics: Obesity
U.S. FDA Resources

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
Daily
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00537810

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

Locations
United States, Connecticut
Yale-New Haven Hospital (YNHH) Primary Care Center (PCC) Recruiting
New Haven, Connecticut, United States, 06510
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
Sponsors and Collaborators
Yale University
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Carlos M. Grilo, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov 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:
Obesity
Binge eating
Sibutramine
Self-help
Primary care

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Obesity
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Sibutramine
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013