Treatment of Binge Eating in Obese Patients in Primary Care

NCT ID: NCT00537810

Last Updated: 2021-08-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Binge Eating

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Sibutramine

Sibutramine 15 mg daily

Group Type EXPERIMENTAL

Sibutramine

Intervention Type DRUG

15 mg daily

Placebo

Placebo Daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Daily

Placebo/CBTsh

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

Group Type EXPERIMENTAL

Self-help CBT + Sibutramine

Intervention Type BEHAVIORAL

Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily

Sibutramine/CBTsh

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

Group Type EXPERIMENTAL

Self-help CBT + Placebo

Intervention Type BEHAVIORAL

Cognitive behavioral treatment manual for binge eating Placebo daily

Interventions

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Sibutramine

15 mg daily

Intervention Type DRUG

Placebo

Daily

Intervention Type DRUG

Self-help CBT + Sibutramine

Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily

Intervention Type BEHAVIORAL

Self-help CBT + Placebo

Cognitive behavioral treatment manual for binge eating Placebo daily

Intervention Type BEHAVIORAL

Other Intervention Names

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Meridia

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Carlos Grilo

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carlos M. Grilo, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale Internal Medicine Associates (YIMA)

New Haven, Connecticut, United States

Site Status

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

New Haven, Connecticut, United States

Site Status

Yale Psychiatric Research at Congress Place

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 24857821 (View on PubMed)

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

Reference Type DERIVED
PMID: 26214545 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25622201 (View on PubMed)

Other Identifiers

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R01DK073542-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0501027352

Identifier Type: -

Identifier Source: org_study_id

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