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Treatment of Binge Eating in Obese Patients in Primary Care

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Carlos Grilo, Yale University
ClinicalTrials.gov Identifier:
NCT00537810
First received: September 27, 2007
Last updated: December 11, 2014
Last verified: December 2014

September 27, 2007
December 11, 2014
September 2007
October 2012   (final data collection date for primary outcome measure)
  • Binge Eating (Remission) [ Time Frame: 4 months treatment; 6 and 12 month follow up post treatment ] [ Designated as safety issue: No ]
    Remission from binge eating (zero binge episodes during previous 28 days)
  • BMI [ Time Frame: 4 months 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
Not Provided
Not Provided
 
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: Sibutramine
    Sibutramine 15 mg daily
    Intervention: Drug: Sibutramine
  • Placebo Comparator: Placebo
    Placebo Daily
    Intervention: Drug: Placebo
  • Experimental: Placebo/CBTsh
    Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating
    Intervention: Behavioral: Self-help CBT + Sibutramine
  • Experimental: Sibutramine/CBTsh
    Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
    Intervention: Behavioral: Self-help CBT + Placebo
Grilo CM, Masheb RM, White MA, Gueorguieva R, Barnes RD, Walsh BT, McKenzie KC, Genao I, Garcia R. Treatment of binge eating disorder in racially and ethnically diverse obese patients in primary care: randomized placebo-controlled clinical trial of self-help and medication. Behav Res Ther. 2014 Jul;58:1-9. doi: 10.1016/j.brat.2014.04.002. Epub 2014 May 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
104
October 2012
October 2012   (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 information is only displayed when the study is recruiting subjects
United States
 
NCT00537810
0501027352, R01DK073542-01A1
Yes
Carlos Grilo, 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
December 2014

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