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Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1)

NCT04599478 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-03-27

No results posted yet for this study

Summary

This study will compare the effectiveness of behavioral and pharmacologic treatments, alone and in combination, for the treatment of loss-of-control eating and weight following bariatric surgery. This is an acute treatment comparing behavioral weight loss alone or in combination with combination naltrexone/bupropion medication.

Conditions

  • Loss-of-control Eating
  • Obesity/Overweight

Interventions

DRUG

Naltrexone and Bupropion medication

NB medication will be taken daily in pill form.

BEHAVIORAL

Behavioral Weight Loss

Behavioral Weight Loss (BWL) counseling includes weekly sessions.

OTHER

Placebo

Placebo will be inactive and taken daily in pill form.

Sponsors & Collaborators

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

    collaborator NIH

  • Yale University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2025-12-12
Completion
2027-01-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04599478 on ClinicalTrials.gov