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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

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

Clinicaltrials.gov identifier NCT03946111

Recruitment Status Recruiting

First Posted May 10, 2019

Last update posted January 7, 2020

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:Binge-Eating Disorder
    Obesity
  • Intervention/Treatment: Drug: Naltrexone and Bupropion
    Other: Placebo
  • Phase: 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
  • Estimated 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: August 2019
  • Estimated Primary Completion Date: July 2024
  • Estimated Study Completion Date: July 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.
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • 2. 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.
  • 3. 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.
  • 4. 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).
  • 5. 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).
  • 6. 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).
  • Secondary Outcome Measures: 1. Binge-Eating Remission [ Time Frame: From baseline interview at study enrollment to 3 months after the 12-week treatment. ]
    Categorical: zero binges/28 days
  • 2. Binge-Eating Remission [ Time Frame: From post-treatment to the 6-month follow-up ]
    Categorical: zero binges/28 days
  • 3. Binge-Eating Remission [ Time Frame: From post-treatment to the 12-month follow-up ]
    Categorical: zero binges/28 days
  • 4. 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).
  • 5. 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).
  • 6. 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).
  • 7. 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).
  • 8. 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).
  • 9. 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).
Eligibility Criteria
  • Ages Eligible for Study: 18 to 64 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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 - 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

Contacts and Locations
Contacts

Contact: Valentina Ivezaj, Ph.D. 203-785-7210 valentina.ivezaj@yale.edu

Locations

United States, Connecticut
Yale Department of Psychiatry
New Haven

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator: Carlos M Grilo, Ph.D. Yale School of Medicine

More Information
  • Responsible Party: Yale University
  • ClinicalTrials.gov Identifier: NCT03946111 History of Changes
  • Other Study ID Numbers: 2000022480_a
  • First Posted: May 10, 2019 Key Record Dates
  • Last Update Posted: January 7, 2020
  • Last Verified: January 2020
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Obesity
    Bulimia
    Feeding and Eating Disorders
    Binge-Eating Disorder