A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Patients

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07398404
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

  • Bariatric Surgery Patients
  • Obesity
  • Smoking Cessation

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Naltrexone hydrochloride — DRUG
    Participants will be given 50mg/day of Naltrexone for 4 months.
  • Bupropion Hydrochloride Extended-release — DRUG
    Participants will be given 300mg/day of Bupropion for 4 months. Bupropion will be taken twice daily (150mg in the morning, followed by 150mg in the late afternoon/early evening).
  • Cognitive-Behavioral Therapy — BEHAVIORAL
    Participants will receive cognitive-behavioral therapy for weight loss and smoking cessation. Participants will meet with their assigned study clinician weekly for 60 minutes for 4 months.

Study Details

The purpose of this research study is to evaluate a multiple health behavior change intervention for weight loss and smoking cessation using medication (Naltrexone + Bupropion) and behavior therapy in adults seeking bariatric surgery. The intervention will be compared to a standard of care control group.

Key Dates

Start date
Jul 1, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2030
Completion
Jun 30, 2031

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: MHBC Intervention Group
    Participants will receive the multiple health behavior intervention with combined behavioral and pharmacotherapy (Naltrexone/Bupropion).
  • No Intervention: Control Group
    Participants will receive the current standard of care treatments and services offered by the bariatric clinic for weight loss and smoking cessation.

Primary Outcome Measure

Study enrollment to assess Feasibility [ Time Frame: 16 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06511
Caitlin E Smith, PhD
[email protected]
203-785-7210

Find similar trials in New Haven, CT

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Yale University· New Haven, CT

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