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

NCT ID: NCT03924193

Last Updated: 2024-10-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 141 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-25
• Study Completion Date: 2023-09-13

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.

Conditions

Binge-Eating Disorder; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

LDX

Group Type: ACTIVE_COMPARATOR

Lisdexamfetamine Dimesylate

Intervention Type: DRUG

Participants randomly assigned to this arm will receive 12 weeks of LDX medication.

Cognitive-Behavioral Therapy

Group Type: ACTIVE_COMPARATOR

Cognitive-Behavioral Therapy

Intervention Type: BEHAVIORAL

Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy

LDX and Cognitive Behavioral Therapy

Group Type: ACTIVE_COMPARATOR

Combination LDX and Cognitive-Behavioral Therapy

Intervention Type: OTHER

Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy

Interventions

Lisdexamfetamine Dimesylate

Participants randomly assigned to this arm will receive 12 weeks of LDX medication.

Intervention Type: DRUG

Cognitive-Behavioral Therapy

Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy

Intervention Type: BEHAVIORAL

Combination LDX and Cognitive-Behavioral Therapy

Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carlos M Grilo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale Department of Psychiatry

New Haven, Connecticut, United States

Countries

United States

References

Yurkow S, Ivezaj V, Pittman B, Grilo CM. Preferences for Lisdexamfetamine vs Cognitive-Behavioral Therapy for Binge-Eating Disorder: Correlates and Outcomes. J Clin Psychiatry. 2025 May 7;86(2):24m15552. doi: 10.4088/JCP.24m15552.

Reference Type: DERIVED

PMID: 40338285 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

1R01DK114075-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000022480_b

Identifier Type: -

Identifier Source: org_study_id