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...
Date First Received: September 27, 2007
Last Updated: April 24, 2008
Verified by: Yale University, April 2008
Clinical Trial Phase: Phase 4 | Start Date: September 2007
Overall Status: Recruiting
Estimated Enrollment: 150
Brief Summary
Official Title: “Treatment of Binge Eating in Obese Patients in Primary Care”
Condition Keyword(s):
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.
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment, Efficacy Study
Study Primary Completion Date: September 2013
Intervention(s) in this Clinical Trial
- Drug: Sibutramine
- 15 mg daily
- Drug: Placebo
- Daily
- Behavioral: Self-help CBT + Sibutramine
- Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily
- Behavioral: Self-help CBT + Placebo
- Cognitive behavioral treatment manual for binge eating Placebo daily
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Sibutramine 15 mg daily
- Placebo Comparator: 2.
- Placebo Daily
- Experimental: 3.
- Self-help CBT and Placebo Placebo daily, Cognitive behavioral self-help manual for binge eating
- Experimental: 4
- Self-help CBT and Sibutramine 15 mg daily Cognitive behavioral treatment manual for binge eating
Outcome Measures for this Clinical Trial
Primary Measures
- Binge Eating
- Time Frame: 6 months treatment; 6 and 12 month follow up post treatment
Safety Issue?: No
- Time Frame: 6 months treatment; 6 and 12 month follow up post treatment
- BMI
- Time Frame: 6 months treatment; 6 and 12 month follow up post treatment
Safety Issue?: No
- Time Frame: 6 months treatment; 6 and 12 month follow up post treatment
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 60 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers
Clinical Trial Sponsor Information
Lead Sponsor: Yale University
Overall Clinical Trial Officials and Contacts
Carlos M. Grilo, PhD Principal Investigator Yale University
Overall Contact: Shannon Zaitsoff, Ph.D. 203-785-6395
Additional Information
Information obtained from ClinicalTrials.gov on August 28, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00537810
Study ID Number: R01DK073542-01A1
ClinicalTrials.gov Identifier: NCT00537810
Health Authority: United States: Institutional Review Board
Clinical Trials Authorship and Review
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