Pharmacological and Behavioral Treatment After Bariatric Surgery (NCT05157698)
Behavioral and Pharmacological Treatments to Enhance Weight Outcomes After Metabolic and Bariatric Surgery
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (10 items) and avoid the listed exclusions (20 items).
Location: Yale School of Medicine — New Haven, Connecticut
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Has a predisposition to seizures (e.g., subject with a history or evidence of seizure disorder, febrile seizures during childhood, brain tumor, cerebrovascular disease, or significant head trauma; has a family history of idiopathic seizure disorder or is currently being treated with medications or treatment regimens that lower seizure threshold).
- Has a history of anorexia nervosa or history of bulimia nervosa.
- Is currently taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates).
- Is currently using other medications for weight loss.
- Has a history of allergy or sensitivity to bupropion or naltrexone.
- Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
- Has untreated hypertension with a seated systolic blood pressure \> 160 mmHg, diastolic blood pressure \> 100 mmHg, or heart rate \> 100 beats/minute.
- Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.
- Has current uncontrolled hypertension.
- Has current uncontrolled Type I or Type 2 diabetes mellitus.
- Has untreated hypothyroidism with a TSH \> 1.5 times the upper limit of normal for the test laboratory with repeat value that also exceeds this limit.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Yale School of Medicine — New Haven, Connecticut
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.