Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders

Yale University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Binge-Eating Disorder; Obesity

Treatments: Other: Placebo; Drug: Naltrexone and Bupropion

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03946111

2000022480_a

1R01DK114075-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will test the relative efficacy and effectiveness of the combination of naltrexone and bupropion (NB) medication as a treatment for binge-eating disorder (BED) in patients with obesity. This is a controlled test of whether, amongst non-responders to acute treatments, NB medication results in superior outcomes compared with placebo.

Full description

Obesity is a heterogeneous problem and research has highlighted the particular significance of a subgroup with binge-eating disorder (BED), the most prevalent formal eating disorder. Improved treatments for patients with obesity and BED are needed that can produce sustained clinical outcomes and promote weight loss. This study RCT will provide new and novel findings from a controlled test, amongst non-responders to acute treatments, whether Naltrexone/Bupropion medication results in superior and longer-term outcomes than placebo.

Enrollment: 3 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 to 64 years old
• Meets DSM-5 criteria for binge-eating disorder
• BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and <50
• Medically cleared as determined by EKG and medical record review
• Available for the duration of the treatment and follow-up (18 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

• Previous history of problems with LDX or other stimulants
• Current psychostimulant use or use of any medication for ADHD
• Current use of study medications: LDX (Vyvanse), Bupropion (Wellbutrin, Zyban), Naltrexone, or Contrave
• History of congenital heart disease, known structural cardiac abnormalities, cardiomyopathy, serious heart arrhythmia, coronary artery disease, cerebrovascular pathology including stroke, exertional chest pain, uncontrolled high blood pressure, and other serious heart problems.
• History of severe renal, hepatic, neurological, or chronic pulmonary disease or other serious, unstable medical disorder.
• Current uncontrolled hypertension
• Current uncontrolled type I or II diabetes mellitus
• Current uncontrolled thyroid illness
• Gallbladder disease
• Co-occurring severe mental illness requiring hospitalization or intensive treatment
• Endorses current active suicidal or homicidal ideation with intent or plan
• History or current alcohol or substance use disorder (smoking is not exclusionary)
• Predisposition to seizures
• History of anorexia nervosa or bulimia nervosa, or currently regularly self-inducing vomiting
• Currently taking MAOI, SSRI or strong inhibitors of CYP2D6
• History of allergy or sensitivity to the study medication or stimulant medications
• Current use of medications contraindicated with the study medications
• Currently breast feeding or pregnant, or not willing to use reliable form of contraception
• Currently taking opioid pain medications or drugs
• Currently using effective treatment (evidence-based therapeutic or psychopharmacologic) for eating and/or weight loss
• Currently participating in another clinical study in which the participant is or will be exposed to an investigational or a non-investigational drug or device
• Medical status judged by study physician as contraindication

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups, including a placebo group

Naltrexone/Bupropion

Experimental group

Treatment:

Drug: Naltrexone and Bupropion

Placebo

Placebo Comparator group

Treatment:

Other: Placebo