Clinical trial NCT03946111: Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Medication Change for Non-Responders
Official title: Cognitive-Behavioral and Pharmacologic Treatment of Binge-Eating Disorder 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: 2019-05-10
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Binge-Eating Frequency
timeFrame: From baseline interview at study enrollment to 3 months after the 12-week treatment.
measure: Binge-Eating Frequency
timeFrame: From post-treatment to the 6-month follow-up
measure: Binge-Eating Frequency
timeFrame: From post-treatment to the 12-month follow-up
measure: Body Mass Index
timeFrame: From baseline interview at study enrollment to 3 months after the 12-week treatment.
measure: Body Mass Index
timeFrame: From post-treatment to the 6-month follow-up
measure: Body Mass Index
timeFrame: From post-treatment to the 12-month follow-up
Secondary outcomes:
measure: Binge-Eating Remission
timeFrame: From baseline interview at study enrollment to 3 months after the 12-week treatment.
measure: Binge-Eating Remission
timeFrame: From post-treatment to the 6-month follow-up
measure: Binge-Eating Remission
timeFrame: From post-treatment to the 12-month follow-up
measure: Eating-Disorder Psychopathology (Continuous)
timeFrame: From baseline interview at study enrollment to 3 months after the 12-week treatment.
measure: Eating-Disorder Psychopathology (Continuous)
timeFrame: From post-treatment to the 6-month follow-up
measure: Eating-Disorder Psychopathology (Continuous)
timeFrame: From post-treatment to the 12-month follow-up
measure: Depressive Symptoms
timeFrame: From baseline interview at study enrollment to 3 months after the 12-week treatment.
measure: Depressive Symptoms
timeFrame: From post-treatment to the 6-month follow-up
measure: Depressive Symptoms
timeFrame: From post-treatment to the 12-month follow-up
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Department of Psychiatry
state: Connecticut
Study officials:
affiliation: Yale University
name: Carlos M Grilo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: