CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 26 enrolled
Drug / intervention
Early Non-responder: BWL continued with medication added +2 morecombination
Likely dose
Not stated in 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/NCT04662801
NCT04662801Phase 3Completed
CompareCT.gov

A Behavioral Treatment With Sequenced Adjunctive Pharmacotherapy for Weight Regain After Bariatric Surgery: A Pilot Study

Yale University·interventional·Posted Dec 10, 2020·Updated Nov 13, 2023

In Brief

A Phase 3 clinical trial evaluating Behavioral Weight Loss (BWL), Early Responder: BWL continued, and 1 other intervention for Obesity, Overweight. Completed, enrolled 26 participants across 1 site.

Detailed Summary

This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Overweight
CountriesUnited States
CollaboratorsAmerican Psychological Foundation

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 10, 2020
Enrollment StartAug 5, 2021
Primary CompletionSep 13, 2022
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 5.6 years ago

Interventions

Behavioral Weight Loss (BWL)behavioral

All participants will receive twelve weeks of BWL treatment.

Early Responder: BWL continuedbehavioral

Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.

Early Non-responder: BWL continued with medication addedcombination

Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.