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| Sponsors and Collaborators: |
Yale University National Institutes of Health (NIH) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | Yale University |
| ClinicalTrials.gov Identifier: | NCT00537810 |
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 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 |
|---|---|
|
1: Experimental
Sibutramine 15 mg daily
|
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
|
Behavioral: Self-help CBT + Sibutramine
Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
|
|
4: Experimental
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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Shannon Zaitsoff, 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 |
More Information
| 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: | April 24, 2008 |
| ClinicalTrials.gov Identifier: | NCT00537810 |
| Health Authority: | United States: Institutional Review Board |
|
Obesity Binge eating Sibutramine Self-help Primary care |
|
Obesity Signs and Symptoms, Digestive Overweight Hyperphagia Body Weight Sibutramine Bulimia Nervosa |
Signs and Symptoms Mental Disorders Bulimia Nutrition Disorders Overnutrition Eating Disorders |
|
Anti-Obesity Agents Therapeutic Uses Psychotropic Drugs Appetite Depressants |
Central Nervous System Agents Antidepressive Agents Pharmacologic Actions |
