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Treatment of Binge Eating in Obese Patients in Primary Care

Primary Purpose

Obesity, Binge Eating

Status

Completed

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Sibutramine

Placebo

Self-help CBT + Sibutramine

Self-help CBT + Placebo

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Binge eating, Sibutramine, Self-help, Primary care

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Yale Internal Medicine Associates (YIMA)
Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)
Yale Psychiatric Research at Congress Place

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Sibutramine

Placebo

Placebo/CBTsh

Sibutramine/CBTsh

Arm Description

Sibutramine 15 mg daily

Placebo Daily

Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating

Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating

Outcomes

Primary Outcome Measures

Binge Eating (Remission)

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

BMI

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00537810

First Posted

September 27, 2007

Last Updated

August 16, 2021

Sponsor

Yale University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00537810

Brief Title

Treatment of Binge Eating in Obese Patients in Primary Care

Official Title

Treatment of Binge Eating in Obese Patients in Primary Care

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Binge Eating

Keywords

Obesity, Binge eating, Sibutramine, Self-help, Primary care

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sibutramine

Arm Type

Experimental

Arm Description

Sibutramine 15 mg daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo Daily

Arm Title

Placebo/CBTsh

Arm Type

Experimental

Arm Description

Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating

Arm Title

Sibutramine/CBTsh

Arm Type

Experimental

Arm Description

Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating

Intervention Type

Drug

Intervention Name(s)

Sibutramine

Other Intervention Name(s)

Meridia

Intervention Description

15 mg daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Daily

Intervention Type

Behavioral

Intervention Name(s)

Self-help CBT + Sibutramine

Intervention Description

Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily

Intervention Type

Behavioral

Intervention Name(s)

Self-help CBT + Placebo

Intervention Description

Cognitive behavioral treatment manual for binge eating Placebo daily

Primary Outcome Measure Information:

Title

Binge Eating (Remission)

Description

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

Time Frame

4 months treatment; 6 and 12 month follow up post treatment

Title

BMI

Description

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

Time Frame

4 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Carlos M. Grilo, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale Internal Medicine Associates (YIMA)

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Yale-New Haven Hospital (YNHH) Primary Care Center (PCC)

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06510

Country

United States

Facility Name

Yale Psychiatric Research at Congress Place

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06519

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

24857821

Citation

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.

Results Reference

result

PubMed Identifier

26214545

Citation

Correction to Grilo et al. (2015). J Consult Clin Psychol. 2015 Aug;83(4):747. doi: 10.1037/ccp0000043.

Results Reference

derived

PubMed Identifier

25622201

Citation

Grilo CM, White MA, Masheb RM, Gueorguieva R. Predicting meaningful outcomes to medication and self-help treatments for binge-eating disorder in primary care: The significance of early rapid response. J Consult Clin Psychol. 2015 Apr;83(2):387-94. doi: 10.1037/a0038635. Epub 2015 Jan 26. Erratum In: J Consult Clin Psychol. 2015 Aug;83(4):747.

Results Reference

derived

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Treatment of Binge Eating in Obese Patients in Primary Care

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