Obesity, Overweight
Conditions
Brief summary
This study will examine behavioral and pharmacologic (Naltrexone+Bupropion) treatments for weight regain after bariatric surgery.
Interventions
BEHAVIORALBehavioral Weight Loss (BWL)
All participants will receive twelve weeks of BWL treatment.
BEHAVIORALEarly Responder: BWL continued
Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
COMBINATION_PRODUCTEarly Non-responder: BWL continued with medication added
Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
Sponsors
American Psychological Foundation
Yale University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Body Mass Index | Post-treatment (3 months) | BMI is calculated using measured height and weight- kg/m2. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Eating Disorder Psychopathology | Post-treatment (3 months) | Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology). |
| Food Craving | Post-treatment (3 months) | Food craving will be assessed by the Food Craving Inventory (FCI). FCI scores range from 1-5, with higher scores indicative of greater craving. |
| Depressive Symptoms | Post-treatment (3 months) | Depressive symptoms will be assessed by the Patient Health Questionnaire-9. The range is 0-27, which higher scores indicative of greater depressive symptomatology |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Behavioral Weight Loss Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Responder: BWL continued: Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment. | 12 |
| Behavioral Weight Loss + Medication Behavioral Weight Loss (BWL): All participants will receive twelve weeks of BWL treatment.
Early Non-responder: BWL continued with medication added: Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment. | 10 |
| Total | 22 |
Baseline characteristics
| Characteristic | Behavioral Weight Loss | Total | Behavioral Weight Loss + Medication |
|---|---|---|---|
| Age, Continuous | 51.17 years STANDARD_DEVIATION 11.01 | 49.05 years STANDARD_DEVIATION 9.73 | 46.5 years STANDARD_DEVIATION 7.71 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 20 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 9 Participants | 16 Participants | 7 Participants |
| Region of Enrollment United States | 12 participants | 22 participants | 10 participants |
| Sex: Female, Male Female | 10 Participants | 18 Participants | 8 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 12 | 0 / 10 |
| other Total, other adverse events | 0 / 12 | 7 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
Primary
Body Mass Index
BMI is calculated using measured height and weight- kg/m2.
Time frame: Post-treatment (3 months)
Population: Participants with complete data at follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss | Body Mass Index | 39.12 kg/m2 | Standard Deviation 4.57 |
| Behavioral Weight Loss + Medication | Body Mass Index | 40.48 kg/m2 | Standard Deviation 4.89 |
Secondary
Depressive Symptoms
Depressive symptoms will be assessed by the Patient Health Questionnaire-9. The range is 0-27, which higher scores indicative of greater depressive symptomatology
Time frame: Post-treatment (3 months)
Population: Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss | Depressive Symptoms | 3.89 units on a scale | Standard Deviation 5.21 |
| Behavioral Weight Loss + Medication | Depressive Symptoms | 3.67 units on a scale | Standard Deviation 2.58 |
Secondary
Eating Disorder Psychopathology
Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Time frame: Post-treatment (3 months)
Population: Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss | Eating Disorder Psychopathology | 1.53 units on a scale | Standard Deviation 0.8 |
| Behavioral Weight Loss + Medication | Eating Disorder Psychopathology | 1.46 units on a scale | Standard Deviation 0.94 |
Secondary
Food Craving
Food craving will be assessed by the Food Craving Inventory (FCI). FCI scores range from 1-5, with higher scores indicative of greater craving.
Time frame: Post-treatment (3 months)
Population: Participants with complete data at follow up- 1 participant did not complete questionnaires in the Behavioral Weight Loss + Medication group at follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Behavioral Weight Loss | Food Craving | 1.65 units on a scale | Standard Deviation 0.49 |
| Behavioral Weight Loss + Medication | Food Craving | 1.57 units on a scale | Standard Deviation 0.29 |