Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity
Overview
- Phase
- Phase 2
- Intervention
- Naltrexone and Bupropion
- Conditions
- Binge-Eating Disorder
- Sponsor
- Yale University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Change in Binge-Eating Frequency
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •18 to 64 years old
- •Meets DSM-5 criteria for binge-eating disorder
- •BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and \<50
- •Medically cleared as determined by EKG and medical record review
- •Available for the duration of the treatment and follow-up (18 months)
- •Read, comprehend, and write English at a sufficient level to complete study-related materials
- •Able to travel to study location (New Haven, CT) for weekly visits
Exclusion Criteria
- •Previous history of problems with LDX or other stimulants
- •Current psychostimulant use or use of any medication for ADHD
- •Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave
- •History of congenital heart disease, known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, cerebrovascular pathology including stroke, exertional chest pain, uncontrolled high blood pressure, and other serious heart problems.
- •History of severe renal, hepatic, neurological, or chronic pulmonary disease or other serious, unstable medical disorder.
- •Current uncontrolled hypertension
- •Current uncontrolled type I or II diabetes mellitus
- •Current uncontrolled thyroid illness
- •Gallbladder disease
- •Co-occurring severe mental illness requiring hospitalization or intensive treatment
Arms & Interventions
Naltrexone/Bupropion
Intervention: Naltrexone and Bupropion
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change in Binge-Eating Frequency
Time Frame: From baseline interview at study enrollment to 3 months after the 12-week treatment.
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.
Change in Binge-Eating Frequency
Time Frame: From post-treatment to the 6-month follow-up
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.
Percent Change in Weight
Time Frame: From baseline interview at study enrollment to 3 months after the 12-week treatment.
Negative values indicate weight loss and positive values indicate weight gain.
Percent Change in Weight
Time Frame: From post-treatment to the 6-month follow-up
Negative values indicate weight loss and positive values indicate weight gain.
Change in Binge-Eating Frequency
Time Frame: From post-treatment to the 12-month follow-up
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.
Percent Change in Weight
Time Frame: From post-treatment to the 12-month follow-up
Negative values indicate weight loss and positive values indicate weight gain.
Secondary Outcomes
- Binge-Eating Remission(12-month follow-up)
- Change in Eating-Disorder Psychopathology (Continuous)(From post-treatment to the 12-month follow-up)
- Change in Depressive Symptoms(From post-treatment to the 12-month follow-up)
- Binge-Eating Remission(12-weeks)
- Binge-Eating Remission(6-month follow-up)
- Change in Eating-Disorder Psychopathology (Continuous)(From baseline interview at study enrollment to 3 months after the 12-week treatment.)
- Change in Eating-Disorder Psychopathology (Continuous)(From post-treatment to the 6-month follow-up)
- Change in Depressive Symptoms(From baseline interview at study enrollment to 3 months after the 12-week treatment.)
- Change in Depressive Symptoms(From post-treatment to the 6-month follow-up)