Treatment of Binge Eating in Obese Patients in Primary Care

August 16, 2021 updated by: Carlos Grilo, Yale University
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Yale Psychiatric Research at Congress Place
      • New Haven, Connecticut, United States, 06510
        • Yale Internal Medicine Associates (YIMA)
      • New Haven, Connecticut, United States, 06510
        • Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sibutramine
Sibutramine 15 mg daily
Drug: Sibutramine
15 mg daily
Other Names:
  • Meridia
Placebo Comparator: Placebo
Placebo Daily
Drug: Placebo
Daily
Experimental: Placebo/CBTsh
Placebo and Self-help CBT 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
Experimental: Sibutramine/CBTsh
Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating
Behavioral: Self-help CBT + Placebo
Cognitive behavioral treatment manual for binge eating Placebo daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
4 months treatment; 6 and 12 month follow up post treatment
BMI
Time Frame: 4 months
BMI (kg/m^2) was measured 4 months after treatment.
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

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

Investigators

  • Principal Investigator: Carlos M. Grilo, PhD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

September 27, 2007

First Submitted That Met QC Criteria

September 30, 2007

First Posted (Estimate)

October 1, 2007

Study Record Updates

Last Update Posted (Actual)

August 18, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0501027352
  • R01DK073542-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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