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Pharmacological and Behavioral Treatment After Bariatric Surgery

NCT05157698 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-06-18

No results posted yet for this study

Summary

This study will compare the effectiveness of behavioral and pharmacologic treatment, alone and combined, for improvements in weight loss, cardiovascular risk factors, and psychosocial functioning following metabolic and bariatric surgery.

Conditions

Interventions

DRUG

Naltrexone and Bupropion Combination

Participants in this intervention will take active naltrexone and bupropion pills.

BEHAVIORAL

Behavioral Weight Loss

Participants in this intervention will receive behavioral weight loss treatment.

OTHER

Placebo

Participants in this intervention will take inactive (placebo) pills.

Sponsors & Collaborators

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

    collaborator NIH

  • Yale University

    lead OTHER

Principal Investigators

  • Valentina Ivezaj, Ph.D. · Yale University

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
2022-01-13
Primary Completion
2027-01-12
Completion
2028-01-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05157698 on ClinicalTrials.gov