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

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ClinicalTrials.gov Identifier: NCT03045341
Recruitment Status : Recruiting
First Posted : February 7, 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

Tracking Information
First Submitted Date  ICMJE February 3, 2017
First Posted Date  ICMJE February 7, 2017
Last Update Posted Date May 24, 2019
Actual Study Start Date  ICMJE February 27, 2017
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
  • 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).
  • Body Mass Index [ Time Frame: Post-treatment (4 months) ]
    BMI is calculated using measured height and weight (e.g., percent loss)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03045341 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2017)
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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment
Official Title  ICMJE Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Binge-eating Disorder
  • Obesity
Intervention  ICMJE
  • Drug: NB medication (Naltrexone Bupropion combination)
    NB medication
    Other Name: Contrave
  • Behavioral: Behavioral Weight Loss (BWL) counseling
    BWL counseling
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: NB medication (Naltrexone Bupropion combination)
    • Behavioral: Behavioral Weight Loss (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.
    Interventions:
    • Behavioral: Behavioral Weight Loss (BWL) counseling
    • Other: 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.
    Intervention: Drug: NB medication (Naltrexone Bupropion combination)
  • 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.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 3, 2017)
160
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2023
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Janet Lydecker, PhD 203-785-7210 janet.lydecker@yale.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03045341
Other Study ID Numbers  ICMJE 1506016065-A
R01DK049587 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yale University
Study Sponsor  ICMJE Yale University
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Carlos Grilo, PhD Yale School of Medicine
PRS Account Yale University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP