Pharmacological and Behavioral Treatments After Bariatric Surgery: Maintenance Treatment (Stage 2a)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Naltrexone+Bupropion Medication
|
Drug: Naltrexone and Bupropion (NB) medication
NB medication will be taken daily in pill form.
Other Names:
|
| Placebo Comparator: Placebo
|
Other: Placebo
Placebo will be inactive and taken daily in pill form.
|
Outcome Measures
Primary Outcome Measures
- Loss-of-control eating Relapse [From baseline interview at study enrollment to after the 12-week treatment]
Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.
- Loss-of-control eating Relapse [From post-treatment to the 6-month follow-up]
Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.
- Loss-of-control eating Relapse [From post-treatment to the 12-month follow-up]
Relapse will be scored as a yes/no (categorical variable); this categorical variable will be based on frequency of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Relapse category will be defined as ≥4 loss-of-control eating per month.
- Body Mass Index (BMI) [From baseline at study enrollment to after the 12-week treatment]
BMI is calculated using measured height and weight
- Body Mass Index (BMI) [From post-treatment to the 6-month follow-up]
BMI is calculated using measured height and weight
- Body Mass Index (BMI) [From post-treatment to the 12-month follow-up]
BMI is calculated using measured height and weight
Secondary Outcome Measures
- Loss-of-control eating Frequency [From baseline interview at study enrollment to after the 12-week treatment]
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
- Loss-of-control eating Frequency [From post-treatment to the 6-month follow-up]
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
- Loss-of-control eating Frequency [From post-treatment to the 12-month follow-up]
Loss-of-control eating frequency is a continuous variable of loss-of-control eating episodes assessed using the Eating Disorder Examination interview; Loss-of-control eating frequency will be based on the past 28 days and defined as loss-of-control eating episodes per month.
- Eating Disorder Psychopathology [From baseline interview at study enrollment to after the 12-week treatment]
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).
- Eating Disorder Psychopathology [From post-treatment to the 6-month follow-up]
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).
- Eating Disorder Psychopathology [From post-treatment to the 12-month follow-up]
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).
- Depressive Symptoms [From baseline at study enrollment to after the 12-week treatment]
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
- Depressive Symptoms [From post-treatment to the 6-month follow-up]
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
- Depressive Symptoms [From post-treatment to the 12-month follow-up]
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Patient Health Questionnaire - 9. Scores range from 0-27 (0=no depressive symptoms, 27=greater depressive symptoms).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Be in the age range ≥18 years of age and ≤70 years of age.
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Have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy
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Approximately ten months post-surgery
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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
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Be an otherwise healthy subject without uncontrolled medical problems, as determined by the study physician and medical co-investigators (physical examination, laboratory studies).
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Read, comprehend, and write English at a sufficient level to complete study-related materials.
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Provide a signed and dated written informed consent prior to study participation.
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Be available for participation in the study for up to 15 months (3-month treatment plus 12-month follow up).
Exclusion Criteria:
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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).
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Has a history of anorexia nervosa or history of bulimia nervosa.
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Is currently taking a medication that is a contraindication to NB medication (e.g., MAOI, opiates).
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Is currently using other medications for weight loss.
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Has a history of allergy or sensitivity to bupropion or naltrexone.
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Has a co-existing psychiatric condition that requires hospitalization or more intensive treatment (such as bipolar mood disorders, psychotic illnesses, or severe depression)
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Has untreated hypertension with a seated systolic blood pressure > 160 mmHg, diastolic blood pressure > 100 mmHg, or heart rate > 100 beats/minute.
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Has a history of congenital heart disease, cardiovascular disease, cardiac arrhythmias requiring medication, or a history of cerebrovascular pathology including stroke.
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Has current uncontrolled hypertension.
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Has current uncontrolled Type I or Type II diabetes mellitus.
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Has untreated hypothyroidism with a TSH > 1.5 times the upper limit of normal for the
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test laboratory with repeat value that also exceeds this limit.
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Has gallbladder disease.
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Has a history of severe renal, hepatic, neurological, chronic pulmonary disease, or any other unstable medical disorder.
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Has a recent history of drug or alcohol dependence (since having bariatric surgery).
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Is currently in active treatment for eating or weight loss.
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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.
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Is breast-feeding or is pregnant or is not using a reliable form of birth control.
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Reports active suicidal or homicidal ideation.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Yale School of Medicine | New Haven | Connecticut | United States | 06510 |
Sponsors and Collaborators
- Yale University
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Valentina Ivezaj, Ph.D., Yale University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2000029057a
- 5R01DK126637-02