Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
NCT07224087

Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

Led by Yale University · Updated on 2026-03-19

20

Participants Needed

1

Research Sites

95 weeks

Total Duration

On this page

Sponsors

Y

Yale University

Lead Sponsor

A

American Society for Metabolic and Bariatric Surgery

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this research study is to develop and pilot a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery.

CONDITIONS

Official Title

Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Actively considering bariatric surgery
  • Smoke at least 5 cigarettes daily for the past 3 months
  • Have a body mass index (BMI) of 30.0 kg/m2 or higher
  • Not currently taking medications that interact with Naltrexone or Bupropion
  • No history of medical conditions contraindicated with Naltrexone or Bupropion
  • Physically able to participate in the intervention (e.g., walk independently)
  • Able to speak, read, and write in English
  • Between 18 and 65 years old
  • Not pregnant, breastfeeding, or planning pregnancy during the study
  • No active suicidal or homicidal thoughts
Not Eligible

You will not qualify if you...

  • History or risk of seizures or conditions that lower seizure threshold
  • History of anorexia nervosa or bulimia nervosa
  • Currently taking medications contraindicated with Naltrexone or Bupropion
  • Allergy or sensitivity to Naltrexone or Bupropion
  • Co-existing psychiatric conditions requiring hospitalization or intensive treatment
  • Untreated high blood pressure or elevated heart rate
  • History of heart disease, cardiac arrhythmias, cerebrovascular diseases including stroke
  • Uncontrolled Type I or Type 2 diabetes mellitus
  • Severe kidney, liver, neurological, lung, or gallbladder disease or other unstable conditions
  • Currently breastfeeding, pregnant, or not using reliable birth control
  • Active suicidal or homicidal ideation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Yale University

New Haven, Connecticut, United States, 06511

Actively Recruiting

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Research Team

C

Caitlin E Smith, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Development of a MHBC Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients | DecenTrialz