Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 56 of 592 for:    binge eating disorder

Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03045341
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : March 26, 2018
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 effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.

Condition or disease Intervention/treatment Phase
Binge-eating Disorder Obesity Drug: NB medication (Naltrexone Bupropion combination) Behavioral: Behavioral Weight Loss (BWL) counseling 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 obese patients with BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (acute treatment stage) aims to test the effectiveness of behavioral weight loss (BWL) and pharmacological treatment with Naltrexone/Bupropion (NB; a recently FDA-approved anti-obesity combination medication), alone and in combination, for the treatment of BED in patients with obesity. The acute treatment stage stage RCT will provide new findings regarding the effectiveness of NB medication and whether this specific combination of BWL and NB medication is effective for patients with obesity and BED. N=160 patients with BED and obesity will be randomly assigned (double-blind) in a balanced factorial (2 X 2) design trial, to one of four 16-week interventions: BWL+NB, BWL+Placebo, NB, or Placebo. This study will produce important new information about the relative efficacy of BWL and this recently FDA-approved anti-obesity (NB medicine), alone and in combination, for BED in patients with obesity.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
Actual Study Start Date : February 27, 2017
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Arm Intervention/treatment
Experimental: BWL + NB medication
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
Drug: NB medication (Naltrexone Bupropion combination)
NB medication
Other Name: Contrave

Behavioral: Behavioral Weight Loss (BWL) counseling
BWL counseling

Experimental: BWL + Placebo
Participants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
Behavioral: Behavioral Weight Loss (BWL) counseling
BWL counseling

Other: Placebo
Placebo

Experimental: NB medication
Participants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
Drug: NB medication (Naltrexone Bupropion combination)
NB medication
Other Name: Contrave

Placebo Comparator: Placebo
Participants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
Other: Placebo
Placebo




Primary Outcome Measures :
  1. Binge Eating Frequency (Continuous) [ Time Frame: Post-treatment (4 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. Body Mass Index [ Time Frame: Post-treatment (4 months) ]
    BMI is calculated using measured height and weight (e.g., percent loss)


Secondary Outcome Measures :
  1. Responder Status [ Time Frame: Post-treatment (4 months) ]
    Binge eating frequency will be assessed by interview and self-report. Frequency is defined categorically (response to treatment or non-response to treatment).



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.


Layout table for eligibility information
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 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50;
  • Available for the duration of the treatment and follow-up (20 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:

  • Currently taking anti-depressant medications;
  • Currently taking opioid pain medications or drugs;
  • 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, 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): NCT03045341


Contacts
Layout table for location contacts
Contact: Janet Lydecker, PhD 203-785-7210 janet.lydecker@yale.edu

Locations
Layout table for location information
United States, Connecticut
Yale School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Contact: Janet A Lydecker, PhD    203-737-4299    janet.lydecker@yale.edu   
Sponsors and Collaborators
Yale University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Carlos Grilo, PhD Yale School of Medicine

Layout table for additonal information
Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03045341     History of Changes
Other Study ID Numbers: 1506016065-A
R01DK049587 ( U.S. NIH Grant/Contract )
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Nutrition Disorders
Mental Disorders
Obesity
Overnutrition
Overweight
Body Weight
Signs and Symptoms
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
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors