CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 104 enrolled
Drug / intervention
Sibutramine +3 moredrug
Likely dose
Sibutramine 15 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00537810
NCT00537810Phase 4Completed
CompareCT.gov

Treatment of Binge Eating in Obese Patients in Primary Care

Yale University·interventional·Posted Oct 1, 2007·Updated Aug 18, 2021

In Brief

A Phase 4 clinical trial evaluating Sibutramine, Placebo, and 2 other interventions for Obesity and Binge Eating. Completed, enrolled 104 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Binge Eating
CountriesUnited States
CollaboratorsNational Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Timeline

Phase 4CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 1, 2007
Enrollment StartSep 1, 2007
Primary CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 18.8 years ago

Interventions

Sibutraminedrug

15 mg daily

Placebodrug

Daily

Self-help CBT + Sibutraminebehavioral

Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily

Self-help CBT + Placebobehavioral

Cognitive behavioral treatment manual for binge eating Placebo daily