CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 31 enrolled
Drug / intervention
NB Medication (on-going from acute treatment) +1 moredrug
Likely dose
Naltrexone/bupropion combination (dose not specified in trial description)AI-extracted
Key inclusion· 4
  • Participated in acute treatment for binge-eating disorder and obesity
  • Did not have a positive response to acute treatment
  • Available for 20 months of treatment and follow-up
  • Able to travel to study location (New Haven, CT) for weekly visits
Key exclusion· 7
  • Currently taking antidepressant medications
  • Currently taking opioid pain medications or drugs
  • Currently taking medications that influence eating or weight
  • History of seizures

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

Search/NCT03063606
NCT03063606Phase 3Completed

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity

Yale University·interventional·Posted Feb 24, 2017·Updated Feb 1, 2024

In Brief

A Phase 3 clinical trial evaluating Cognitive-Behavioral Therapy (CBT) and NB Medication (on-going from acute treatment) for Binge-Eating Disorder and Obesity. Completed, enrolled 31 participants across 1 site.

Detailed Summary

This study will test the effectiveness of cognitive-behavioral therapy as a specialist treatment for binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, cognitive-behavioral therapy augments on-going blinded pharmacotherapy (either naltrexone/bupropion or placebo), compared with no additional behavioral treatment .

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 24, 2017
Enrollment StartSep 5, 2017
Primary CompletionDec 1, 2021
Study CompletionDec 16, 2022
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 9.4 years ago

Interventions

Cognitive-Behavioral Therapy (CBT)behavioral

CBT specialist treatment

NB Medication (on-going from acute treatment)drug

Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)