Cognitive-Behavioral and Pharmacologic (LDX) Treatment of Binge-Eating Disorder and Obesity: Maintenance Treatment
NCT ID: NCT03926052
Last Updated: 2025-12-17
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
61 participants
INTERVENTIONAL
2019-08-07
2024-11-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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LDX
Lisdexamfetamine Dimesylate
Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
Placebo
Placebo
Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Interventions
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Lisdexamfetamine Dimesylate
Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
Placebo
Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Yale University
OTHER
Responsible Party
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Principal Investigators
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Carlos M Grilo, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Yale University
Locations
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Yale Department of Psychiatry
New Haven, Connecticut, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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2000022480
Identifier Type: -
Identifier Source: org_study_id