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Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Maintenance Therapy

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ClinicalTrials.gov Identifier: NCT03047005
Recruitment Status : Enrolling by invitation
First Posted : February 8, 2017
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 effectiveness and relative efficacy of naltrexone/bupropion medication as a maintenance therapy for the treatment of binge eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst responders to acute treatments, naltrexone/bupropion medication results in superior maintenance and longer-term outcomes compared with placebo.

Condition or disease Intervention/treatment Phase
Binge-Eating Disorder Obesity Drug: NB medication (Naltrexone Bupropion 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 obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study (maintenance stage) RCT will provide new and novel findings from a controlled test, amongst responders to acute treatments, whether NB medication results in superior maintenance and longer-term outcomes than placebo. This is the first controlled test of maintenance pharmacotherapy for BED and will be only the third RCT for BED of any medication with follow-up after medication discontinuation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
Actual Study Start Date : August 28, 2017
Estimated Primary Completion Date : October 2023
Estimated Study Completion Date : October 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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. Binge Eating Frequency (Continuous) [ Time Frame: 6-Month Follow-up ]
    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 (Continuous) [ Time Frame: 12-Month Follow-up ]
    Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).

  3. Body Mass Index [ Time Frame: 6-Month Follow-up ]
    BMI is calculated using measured height and weight (e.g., percent loss)

  4. Body Mass Index [ Time Frame: 12-Month Follow-up ]
    BMI is calculated using measured height and weight (e.g., percent loss)



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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:

  • Participated in acute treatment for binge-eating disorder and obesity;
  • Had a positive response to acute treatment;
  • 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; and
  • Able to travel to study location (New Haven, CT) for monthly 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): NCT03047005


Locations
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United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520
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

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03047005     History of Changes
Other Study ID Numbers: 1506016065-M
R01DK049587 ( U.S. NIH Grant/Contract )
First Posted: February 8, 2017    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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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