Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders

Sponsor

Yale University (Other)

Overall Status

Recruiting

CT.gov ID

NCT03946111

Collaborator

(none)

Enrollment

Location

Arms

58.8

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Binge-Eating Disorder Obesity	Drug: Naltrexone and Bupropion Other: Placebo	Phase 2/Phase 3

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity

Actual Study Start Date :

Aug 7, 2019

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Naltrexone/Bupropion	Drug: Naltrexone and Bupropion Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.
Placebo Comparator: Placebo	Other: Placebo Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.

Arm

Intervention/Treatment

Experimental: Naltrexone/Bupropion

Drug: Naltrexone and Bupropion

Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.

Placebo Comparator: Placebo

Other: Placebo

Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.

Outcome Measures

Primary Outcome Measures

Binge-Eating Frequency [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.
Binge-Eating Frequency [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.
Binge-Eating Frequency [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.
Body Mass Index [From baseline interview at study enrollment to 3 months after the 12-week treatment.]
Body Mass Index is calculated using measured height and weight (e.g., percent loss).
Body Mass Index [From post-treatment to the 6-month follow-up]
Body Mass Index is calculated using measured height and weight (e.g., percent loss).
Body Mass Index [From post-treatment to the 12-month follow-up]
Body Mass Index is calculated using measured height and weight (e.g., percent loss).

Secondary Outcome Measures

Binge-Eating Remission [From baseline interview at study enrollment to 3 months after the 12-week treatment.]
Categorical: zero binges/28 days
Binge-Eating Remission [From post-treatment to the 6-month follow-up]
Categorical: zero binges/28 days
Binge-Eating Remission [From post-treatment to the 12-month follow-up]
Categorical: zero binges/28 days
Eating-Disorder Psychopathology (Continuous) [From baseline interview at study enrollment to 3 months 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 (Continuous) [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 (Continuous) [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 interview at study enrollment to 3 months after the 12-week treatment.]
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).
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 Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=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 Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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
Endorses current active suicidal or homicidal ideation with intent or plan
History or current alcohol or substance use disorder (smoking is not exclusionary)
Predisposition to seizures
History of anorexia nervosa or bulimia nervosa, or currently regularly self-inducing vomiting
Currently taking MAOI, SSRI or strong inhibitors of CYP2D6
History of allergy or sensitivity to the study medication or stimulant medications
Current use of medications contraindicated with the study medications
Currently breast feeding or pregnant, or not willing to use reliable form of contraception
Currently taking opioid pain medications or drugs
Currently using effective treatment (evidence-based therapeutic or psychopharmacologic) for eating and/or weight loss
Currently participating in another clinical study in which the participant is or will be exposed to an investigational or a non-investigational drug or device
Medical status judged by study physician as contraindication