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OpenTrials
Completed

NCT Number: NCT00537810

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.

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Key information

Conditions

Obesity Binge Eating Body Weight Bulimia Hyperphagia Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yale Internal Medicine Associates (YIMA), New Haven, Connecticut, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sibutramine

Drug

15 mg daily

Other names: Meridia

Placebo

Drug

Daily

Self-help CBT + Sibutramine

Behavioral

Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily

Self-help CBT + Placebo

Behavioral

Cognitive behavioral treatment manual for binge eating Placebo daily

Primary outcomes

  1. Binge Eating (Remission)

    Time frame: 4 months treatment; 6 and 12 month follow up post treatment

    Remission from binge eating (zero binge episodes during previous 28 days)

  2. BMI

    Time frame: 4 months

    BMI (kg/m^2) was measured 4 months after treatment.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 1, 2007
Registry last updated
Aug 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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