Weight Regain Treatment Post-Bariatric Surgery

  • days left to enroll
  • participants needed
  • sponsor
    Yale University
Updated on 20 October 2021


This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.

Condition Obesity, Overweight
Treatment Behavioral Weight Loss (BWL), Early Responder: BWL continued, Early Non-responder: BWL continued with medication added
Clinical Study IdentifierNCT04662801
SponsorYale University
Last Modified on20 October 2021


Yes No Not Sure

Inclusion Criteria

Be in the age range 18 years of age and 70 years of age
Have a BMI 30 (or BMI 27 with a medical comorbidity) and 50 kg/m2
Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
Experiencing weight regain after bariatric surgery
Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies)
Read, comprehend, and write English at a sufficient level to complete study-related materials
Provide a signed and dated written informed consent prior to study participation
Be available for participation in the study for up to 3 months

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 II 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
Has gallbladder disease
Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder
Has a recent history of drug or alcohol dependence (since having bariatric surgery)
Is currently in active treatment for eating or weight loss
Is currently participating in another clinical study in which the subject is or will be exposed to an investigational or a non-investigational drug or device
Is breast-feeding or is pregnant or is not using a reliable form of birth control
Reports active suicidal or homicidal ideation
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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