Comparing treatments for eating issues after weight loss surgery

Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Acute (Stage 1)

This study is testing different treatments to help people who have had weight loss surgery manage their eating habits and weight better.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Yale University (Academic / other)
• Locations: 1 site (New Haven, Connecticut)
• Trial ID: NCT04599478 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of behavioral and pharmacological treatments for individuals experiencing loss-of-control eating and weight management challenges following bariatric surgery. A total of 160 participants will be randomly assigned to one of four treatment groups over a 16-week period, utilizing a double-blind, balanced factorial design. The interventions include behavioral weight loss strategies, naltrexone/bupropion medication, and placebo treatments. The study aims to determine the best approach for managing eating behaviors and weight post-surgery.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 who have undergone laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy and experience regular loss-of-control eating.

Not a fit: Patients with a predisposition to seizures or uncontrolled medical problems may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide effective treatment options for patients struggling with eating control and weight management after bariatric surgery.

How similar studies have performed: Other studies have shown promise in using behavioral and pharmacological approaches for weight management, making this a potentially impactful area of research.

Eligibility criteria

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.
* 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.

Where this trial is running

New Haven, Connecticut

• Yale Department of Psychiatry — New Haven, Connecticut, United States (Recruiting)

Study contacts

• Study coordinator: Valentina Ivezaj, Ph.D.

Conditions Loss-of-control Eating; Obesity/Overweight