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.
Participants who provide informed consent and are determined to be eligible will then participate in the study. A total of 160 patients with obesity and regular LOC-eating following MBS will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. The randomization will be in equal proportions but stratified by surgery type.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
92
NB medication will be taken daily in pill form.
Behavioral Weight Loss (BWL) counseling includes weekly sessions.
Placebo will be inactive and taken daily in pill form.
Yale Department of Psychiatry
New Haven, Connecticut, United States
Loss-of-control Eating Frequency
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.
Time frame: Post-treatment (4 months)
Percent Weight Loss
Percent weight loss is calculated based on change from pre-treatment to post-treatment at 4 months. Negative values indicate weight loss.
Time frame: Post-treatment (4 months)
Number of Participants With Loss-of-control Eating Remission
Categorical: zero episodes/28 days
Time frame: Post-treatment (4 months)
Number of Participants With 5% Weight Loss
Categorical: 5% weight loss
Time frame: Post-treatment (4 months)
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 (4 months)
Depressive Symptoms
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).
Time frame: Post-treatment (4 months)
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