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

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ClinicalTrials.gov Identifier: NCT03946111
Recruitment Status : Recruiting
First Posted : May 10, 2019
Last Update Posted : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Tracking Information
First Submitted Date  ICMJE April 22, 2019
First Posted Date  ICMJE May 10, 2019
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE August 7, 2019
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • 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.
  • 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.
  • 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.
  • Body Mass Index [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: From post-treatment to the 12-month follow-up ]
    Body Mass Index is calculated using measured height and weight (e.g., percent loss).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
  • Binge-Eating Remission [ Time Frame: From baseline interview at study enrollment to 3 months after the 12-week treatment. ]
    Categorical: zero binges/28 days
  • Binge-Eating Remission [ Time Frame: From post-treatment to the 6-month follow-up ]
    Categorical: zero binges/28 days
  • Binge-Eating Remission [ Time Frame: From post-treatment to the 12-month follow-up ]
    Categorical: zero binges/28 days
  • Eating-Disorder Psychopathology (Continuous) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders
Official Title  ICMJE Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder and Obesity
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge-Eating Disorder
  • Obesity
Intervention  ICMJE
  • Drug: Naltrexone and Bupropion
    Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.
  • Other: Placebo
    Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Study Arms  ICMJE
  • Experimental: Naltrexone/Bupropion
    Intervention: Drug: Naltrexone and Bupropion
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 9, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2024
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Valentina Ivezaj, Ph.D. 203-785-7210 valentina.ivezaj@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03946111
Other Study ID Numbers  ICMJE 2000022480_a
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos M Grilo, Ph.D. Yale School of Medicine
PRS Account Yale University
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP