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
Sponsor:
Collaborators:
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

September 27, 2007
January 26, 2012
September 2007
September 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Binge Eating
  • BMI
Complete list of historical versions of study NCT00537810 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Treatment of Binge Eating in Obese Patients in Primary Care
Treatment of Binge Eating in Obese Patients in Primary Care

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Obesity
  • Binge Eating
  • Drug: Sibutramine
    15 mg daily
    Other Name: Meridia
  • 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
  • Experimental: 1
    Sibutramine 15 mg daily
    Intervention: Drug: Sibutramine
  • Placebo Comparator: 2.
    Placebo Daily
    Intervention: Drug: Placebo
  • Experimental: 3.
    Self-help CBT and Placebo Placebo daily, Cognitive behavioral self-help manual for binge eating
    Intervention: Behavioral: Self-help CBT + Sibutramine
  • Experimental: 4
    Self-help CBT and Sibutramine 15 mg daily Cognitive behavioral treatment manual for binge eating
    Intervention: Behavioral: Self-help CBT + Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
Not Provided
September 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact: Rachel Barnes, Ph.D. 203-785-6395
Contact: Megan Roehrig, Ph.D. 203-785-6040
United States
 
NCT00537810
0501027352, R01DK073542-01A1
Yes
Yale University
Yale University
  • National Institutes of Health (NIH)
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Carlos M. Grilo, PhD Yale University
Yale University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP