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Sponsors and Collaborators: |
Yale University National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
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Information provided by: | Yale University |
ClinicalTrials.gov Identifier: | NCT00537810 |
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 |
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Obesity Binge Eating |
Drug: Sibutramine Drug: Placebo Behavioral: Self-help CBT + Sibutramine Behavioral: Self-help CBT + Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Treatment of Binge Eating in Obese Patients in Primary Care |
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 |
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1: Experimental
Sibutramine 15 mg daily
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Drug: Sibutramine
15 mg daily
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2.: Placebo Comparator
Placebo Daily
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Drug: Placebo
Daily
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3.: Experimental
Self-help CBT and Placebo Placebo daily, Cognitive behavioral self-help manual for binge eating
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Behavioral: Self-help CBT + Sibutramine
Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
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4: Experimental
Self-help CBT and Sibutramine 15 mg daily Cognitive behavioral treatment manual for binge eating
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Behavioral: Self-help CBT + Placebo
Cognitive behavioral treatment manual for binge eating Placebo daily
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Rachel Barnes, Ph.D. | 203-785-6395 | |
Contact: Megan Roehrig, Ph.D. | 203-785-6040 |
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 |
Principal Investigator: | Carlos M. Grilo, PhD | Yale University |
Responsible Party: | Yale University School of Medicine ( Carlos M. Grilo, PhD/ Principal Investigator ) |
Study ID Numbers: | R01DK073542-01A1 |
Study First Received: | September 27, 2007 |
Last Updated: | July 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00537810 History of Changes |
Health Authority: | United States: Institutional Review Board |
Obesity Binge eating Sibutramine Self-help Primary care |
Obesity Signs and Symptoms, Digestive Psychotropic Drugs Overweight Hyperphagia Body Weight Sibutramine Anti-Obesity Agents Bulimia Nervosa |
Signs and Symptoms Mental Disorders Bulimia Appetite Depressants Nutrition Disorders Overnutrition Antidepressive Agents Eating Disorders |
Obesity Signs and Symptoms, Digestive Psychotropic Drugs Overweight Pharmacologic Actions Hyperphagia Body Weight Sibutramine Anti-Obesity Agents Bulimia Nervosa |
Signs and Symptoms Mental Disorders Therapeutic Uses Bulimia Appetite Depressants Nutrition Disorders Overnutrition Central Nervous System Agents Antidepressive Agents Eating Disorders |