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Trial record 2 of 36 for:    Recruiting, Not yet recruiting Studies | Binge-Eating Disorder | United States

Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder

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ClinicalTrials.gov Identifier: NCT03539900
Recruitment Status : Recruiting
First Posted : May 28, 2018
Last Update Posted : May 24, 2019
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Yale University

Brief Summary:
This study will test the efficacy of naltrexone HCI and bupropion HCI (NB) versus placebo in patients with binge-eating disorder (BED), with or without obesity.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination Other: Placebo Phase 2 Phase 3

Detailed Description:
Binge-eating disorder (BED), the most prevalent formal eating disorder, is associated strongly with obesity and bio-psychosocial impairment. Improved treatments for patients with BED are needed that can produce sustained clinical outcomes. This study aims to test the efficacy of Naltrexone/Bupropion (NB; FDA-approved anti-obesity combination medication) for the treatment of BED in patients with and without obesity. The RCT will provide new findings regarding the efficacy of NB medication for reducing binge-eating episodes among patients with BED, for reducing weight among patients with BED and obesity, and whether patients with and without obesity derive differential benefit from NB.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Mechanisms of Naltrexone+Bupropion for Binge Eating Disorder
Actual Study Start Date : April 17, 2018
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : June 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: NB Medication
Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
Drug: Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination
NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
Other Name: Contrave

Placebo Comparator: Placebo
Placebo will be inactive and taken daily in pill form.
Other: Placebo
Placebo will be inactive and taken daily in pill form.




Primary Outcome Measures :
  1. Binge Eating Frequency [ Time Frame: Post-treatment (3 months) ]
    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

  2. Binge Eating Frequency [ Time Frame: 6 months post-treatment ]
    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

  3. Binge Eating Frequency [ Time Frame: 12 months post-treatment ]
    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).


Secondary Outcome Measures :
  1. Body Mass Index [ Time Frame: Post-treatment (3 months) ]
    BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.

  2. Body Mass Index [ Time Frame: 6 months post-treatment ]
    BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.

  3. Body Mass Index [ Time Frame: 12 months post-treatment ]
    BMI will be calculated using measured height and weight. Percent loss will be analyzed dimensionally.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition);
  • BMI in the obesity (BMI >30 and <50) or non-obesity (BMI >21.5 and <29.9) range;
  • Available for the duration of the treatment and follow-up (15 months);
  • Read, comprehend, and write English at a sufficient level to complete study-related materials.

Exclusion Criteria:

  • Currently taking opioid pain medications or drugs; or positive drug screen for opiates
  • Currently taking medications that influence eating/weight;
  • History of seizures;
  • Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
  • Past or current anorexia nervosa or bulimia nervosa;
  • Pregnant or breastfeeding;
  • 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): NCT03539900


Contacts
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Contact: Janet A Lydecker, PhD 2037857210 janet.lydecker@yale.edu

Locations
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United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Janet A Lydecker, PhD         
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Carlos M Grilo, PhD Yale School of Medicine
Principal Investigator: Sherry McKee, PhD Yale School of Medicine

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03539900     History of Changes
Other Study ID Numbers: 2000021769
R01DK112771 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 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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Disease
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Mental Disorders
Pathologic Processes
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Naltrexone
Bupropion
Bupropion hydrochloride, naltrexone hydrochoride drug combination
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
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Obesity Agents