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Phase II-III

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

  • Study HIC#:1506016065
  • Last Updated:07/15/2021

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.

  • Age18 years - 70 years
  • GenderBoth
  • Start Date02/26/2017
  • End Date10/30/2023

Trial Purpose and Description

This trial is testing treatments for binge eating disorder among people with obesity. Participants will be randomly assigned to receive a medication (Naltrexone + Bupropion), which is FDA-approved for weight loss, AND/OR behavioral weight loss treatment (weekly 1-hour meetings with a clinician). Treatments occur in two stages, each of which lasts 4 months (i.e., 8 months total for treatment). The entire study from start to finish is about 20 months). Payment is $100 at each of the longer in-person assessment visits (at 4 months, 4 months later, 6 months later, and 12 months later.

Eligibility 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.

Principal Investigator

Sub-Investigators

  • Ania Jastreboff
  • Cenk Tek
  • Gerard Sanacora

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