This study will test the relative efficacy and effectiveness of the combination of naltrexone and bupropion (NB) medication as a treatment for binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, NB medication results in superior outcomes compared with placebo.
Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether Naltrexone/Bupropion medication results in superior and longer-term outcomes than placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
3
Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.
Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Yale Department of Psychiatry
New Haven, Connecticut, United States
Change in Binge-Eating Frequency
Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment.
Change in Binge-Eating Frequency
Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.
Time frame: From post-treatment to the 6-month follow-up
Change in Binge-Eating Frequency
Binge-eating frequency is a continuous variable of binge-eating episodes assessed using interview (Eating Disorder Examination interview). The Eating Disorder Examination uses a 28 day recall of eating behavior. The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM -5) defines binge-eating as "eating, in a discrete period of time an amount of food that is definitely larger than most people would eat during a similar period of time and under similar circumstances and a sense of loss of control over eating during the episode." The number of episodes that meet this description will be counted and totaled.
Time frame: From post-treatment to the 12-month follow-up
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Percent Change in Weight
Negative values indicate weight loss and positive values indicate weight gain.
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment.
Percent Change in Weight
Negative values indicate weight loss and positive values indicate weight gain.
Time frame: From post-treatment to the 6-month follow-up
Percent Change in Weight
Negative values indicate weight loss and positive values indicate weight gain.
Time frame: From post-treatment to the 12-month follow-up
Binge-Eating Remission
Categorical: zero binges/28 days
Time frame: 12-weeks
Binge-Eating Remission
Categorical: zero binges/28 days
Time frame: 6-month follow-up
Binge-Eating Remission
Categorical: zero binges/28 days
Time frame: 12-month follow-up
Change in Eating-Disorder Psychopathology (Continuous)
Eating-disorder psychopathology is 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: From baseline interview at study enrollment to 3 months after the 12-week treatment.
Change in Eating-Disorder Psychopathology (Continuous)
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: From post-treatment to the 6-month follow-up
Change in Eating-Disorder Psychopathology (Continuous)
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: From post-treatment to the 12-month follow-up
Change in Depressive Symptoms
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).
Time frame: From baseline interview at study enrollment to 3 months after the 12-week treatment.
Change in Depressive Symptoms
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).
Time frame: From post-treatment to the 6-month follow-up
Change in Depressive Symptoms
Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).
Time frame: From post-treatment to the 12-month follow-up