Clinical trial NCT03045341: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment
Official title: Behavioral and Pharmacologic Treatment of Binge Eating and Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Binge-eating Disorder
Obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2017-02-07
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Binge Eating Frequency (Continuous)
timeFrame: Post-treatment (4 months)
measure: Body Mass Index (Percent Weight Loss)
timeFrame: Post-treatment (4 months)
Secondary outcomes:
measure: Number of Participants Meeting Response Criteria
timeFrame: Post-treatment (4 months)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Carlos Grilo, PhD
role: PRINCIPAL_INVESTIGATOR
References: