Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Acute Treatment

Phase 3

Completed

Conditions: Obesity
Binge-Eating Disorder

Interventions: Other: Combination LDX and Cognitive-Behavioral Therapy
Behavioral: Cognitive-Behavioral Therapy
Drug: Lisdexamfetamine Dimesylate

Registration Number: NCT03924193

Lead Sponsor: Yale University

Brief Summary: Brief Summary: This study will compare the effectiveness of cognitive behavioral therapy (CBT), lisdexamfetamine (LDX), and the combination of CBT and LDX for the treatment of binge-eating disorder in patients with obesity. This is an acute treatment comparing CBT or LDX alone or in combination.

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. This study examined the effectiveness of two leading but distinct treatments - lisdexamfetamine (LDX) and cognitive behavioral therapy (CBT) - alone and in combination, for BED in patients with obesity. LDX is the first and only FDA-approved medication for the treatment of BED and has demonstrated short-term effectiveness relative to placebo. CBT is the best-established psychological treatment, has demonstrated short-term effectiveness and "treatment specificity" (i.e., superiority to a variety of control and active treatments), has shown longer-term superiority to fluoxetine, and longer-term durability of outcomes. N=180 participants with BED and obesity will be randomly assigned to one of three interventions, CBT alone, LDX alone, or CBT combined with LDX. This RCT will provide new findings regarding the relative effectiveness of LDX, CBT, and combined CBT+LDX for patients with obesity and BED. No such study has been performed.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 141

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LDX and Cognitive Behavioral Therapy	Combination LDX and Cognitive-Behavioral Therapy	-
Cognitive-Behavioral Therapy	Cognitive-Behavioral Therapy	-
LDX	Lisdexamfetamine Dimesylate	-

Primary Outcome Measures

Name	Time	Method
Binge-Eating Frequency	Post-treatment (3 months)	Binge eating will be assessed by interview and self-report and the primary outcomes is frequency. Frequency will be defined continuously (analyzed dimensionally).
Body Mass Index	Post-treatment (3 months)	BMI is calculated using measured height and weight (e.g., percent loss). We note that % BMI change and % Weight Loss are exactly the same (when height is kept constant, which was the case with this short-term study with adults). Negative values indicate weight loss and positive values indicate weight gain.

Secondary Outcome Measures

Name	Time	Method
Binge-Eating Remission	Post-treatment (3 months)	Categorical: zero binges/28 days
Eating-Disorder Psychopathology	Post-treatment (3 months)	Eating-disorder psychopathology is a continuous variable as assessed by the global score of the Eating Disorder Examination/Eating Disorder Examination-Questionnaire. Scores range from 0-6 (0=no eating-disorder psychopathology; 6=severe eating-disorder psychopathology).
Depressive Symptoms	Post-treatment (3 months)	Depressive symptoms is a continuous variable of depressive symptomatology as assessed by the self-report measure, the Beck Depression Inventory - Second Edition. Scores range from 0-63 (0=no depressive symptoms, 63=greater depressive symptoms).