Clinical trial NCT04605081: Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)
Official title: Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery: Maintenance Treatment (Stage 2a)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
PHASE3
Conditions: Loss-of-Control Eating
Obesity/Overweight
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2020-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will test the effectiveness of naltrexone/bupropion medication as a maintenance therapy for the treatment of loss-of-control eating and weight loss following bariatric surgery. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.


Eligibility criteria: Inclusion Criteria:

* Be in the age range ≥18 years of age and ≤70 years of age.
* Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
* Approximately ten months post-surgery
* Experienced regular loss of control eating about six months after bariatric surgery, and were considered treatment responders to a four-month treatment trial of medication and/or BWL
* 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 15 months (3-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.

Primary outcomes:
measure: Loss-of-control eating Relapse
timeFrame: From baseline interview at study enrollment to after the 12-week treatment
measure: Loss-of-control eating Relapse
timeFrame: From post-treatment to the 6-month follow-up
measure: Loss-of-control eating Relapse
timeFrame: From post-treatment to the 12-month follow-up
measure: Body Mass Index (BMI)
timeFrame: From baseline at study enrollment to after the 12-week treatment
measure: Body Mass Index (BMI)
timeFrame: From post-treatment to the 6-month follow-up
measure: Body Mass Index (BMI)
timeFrame: From post-treatment to the 12-month follow-up
Secondary outcomes:
measure: Loss-of-control eating Frequency
timeFrame: From baseline interview at study enrollment to after the 12-week treatment
measure: Loss-of-control eating Frequency
timeFrame: From post-treatment to the 6-month follow-up
measure: Loss-of-control eating Frequency
timeFrame: From post-treatment to the 12-month follow-up
measure: Eating Disorder Psychopathology
timeFrame: From baseline interview at study enrollment to after the 12-week treatment
measure: Eating Disorder Psychopathology
timeFrame: From post-treatment to the 6-month follow-up
measure: Eating Disorder Psychopathology
timeFrame: From post-treatment to the 12-month follow-up
measure: Depressive Symptoms
timeFrame: From baseline at study enrollment to after the 12-week treatment
measure: Depressive Symptoms
timeFrame: From post-treatment to the 6-month follow-up
measure: Depressive Symptoms
timeFrame: From post-treatment to the 12-month follow-up
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Valentina Ivezaj, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: