Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1) (NCT04599478) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
Pharmacological and Behavioral Treatment After Bariatric Surgery: Acute (Stage 1)
United States160 participantsStarted 2021-06-29
Plain-language summary
This study will compare the effectiveness of behavioral and pharmacologic treatments, alone and in combination, for the treatment of loss-of-control eating and weight following bariatric surgery. This is an acute treatment comparing behavioral weight loss alone or in combination with combination naltrexone/bupropion medication.
Who can participate
Age range18 Years – 70 Years
SexALL
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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
* Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
* Approximately six months post-surgery
* Experience regular loss-of-control eating (defined as at least once weekly over the past 28 days)
* 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 19 months (7-month treatment plus 12-month follow up).
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.
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