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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 : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

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Study Type : Interventional  (Clinical Trial)
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
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

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.




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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03946111


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

Locations
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United States, Connecticut
Yale Department of Psychiatry Recruiting
New Haven, Connecticut, United States, 06510
Contact: Valentina Ivezaj, Ph.D.    203-785-7210    valentina.ivezaj@yale.edu   
Principal Investigator: Carlos M Grilo, Ph.D.         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Carlos M Grilo, Ph.D. Yale School of Medicine

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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: September 27, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Obesity
Disease
Bulimia
Feeding and Eating Disorders
Binge-Eating Disorder
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Naltrexone
Bupropion
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents