Actively Recruiting
Pharmacological and Behavioral Treatment After Bariatric Surgery
Led by Yale University · Updated on 2025-06-18
160
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
Sponsors
Y
Yale University
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pharmacological and Behavioral Treatment After Bariatric Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to follow all study procedures and be available for up to 18 months
- BMI of 30 or higher (or 27 or higher with a medical condition) and 50 or less
- Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
- Suboptimal weight results after metabolic and bariatric surgery
- Otherwise healthy without uncontrolled medical problems as judged by study doctors
- Had a physical exam in the past year
- Able to read, understand, and write English sufficiently for study materials
- Females of reproductive potential must use effective contraception during the study
- Males of reproductive potential must use condoms or other effective contraception methods with partners
You will not qualify if you...
- History or risk of seizures or seizure disorder
- History of anorexia nervosa or bulimia nervosa
- Currently taking medications that conflict with naltrexone and bupropion (e.g., MAOIs, opiates)
- Currently using other weight loss medications
- Allergy or sensitivity to bupropion or naltrexone
- Psychiatric conditions needing hospitalization or intensive treatment (e.g., bipolar disorder, psychosis, severe depression)
- Untreated or uncontrolled hypertension or heart rate over 100 beats/minute
- History of heart disease, cardiac arrhythmias requiring medication, or stroke
- Uncontrolled diabetes mellitus (Type 1 or 2)
- Untreated hypothyroidism beyond lab limits
- Gallbladder disease
- Severe kidney, liver, neurological, lung diseases, or other unstable medical disorders
- Recent drug or alcohol dependence
- Currently in active treatment for eating or weight loss disorders
- Participation in another clinical study involving drug or device exposure
- Breastfeeding, pregnant, or not using reliable birth control
- Active suicidal or homicidal thoughts
- Poor eye health
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Yale School of Medicine
New Haven, Connecticut, United States, 06519
Actively Recruiting
Research Team
V
Valentina Ivezaj, Ph.D.
CONTACT
C
Carlos M Grilo, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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