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

Yale University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Obesity; Binge-eating Disorder

Treatments: Drug: NB medication (Naltrexone Bupropion combination); Other: Placebo; Behavioral: Behavioral Weight Loss (BWL) counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03045341

R01DK049587 (U.S. NIH Grant/Contract)

1506016065-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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136 participants in 4 patient groups, including a placebo group

BWL + NB medication

Experimental group

Description:

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.

Treatment:

Drug: NB medication (Naltrexone Bupropion combination)

Behavioral: Behavioral Weight Loss (BWL) counseling

BWL + Placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo

Behavioral: Behavioral Weight Loss (BWL) counseling

NB medication

Experimental group

Description:

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.

Treatment:

Drug: NB medication (Naltrexone Bupropion combination)

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo