Behavioral and Pharmacologic Treatment of Binge Eating and Obesity: Acute Treatment
2 other identifiers
interventional
136
1 country
1
Brief Summary
This study will test the effectiveness and relative efficacy of behavioral and pharmacologic treatments, alone and in combination, for the treatment of binge eating disorder (BED) in patients with obesity. This is an acute treatment comparing behavioral weight loss alone or in combination with naltrexone/bupropion medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2017
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2017
CompletedFirst Posted
Study publicly available on registry
February 7, 2017
CompletedStudy Start
First participant enrolled
February 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 23, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 16, 2022
CompletedResults Posted
Study results publicly available
December 20, 2022
CompletedMarch 8, 2023
March 1, 2023
4.4 years
February 3, 2017
July 22, 2022
March 3, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Binge Eating Frequency (Continuous)
Binge eating will be assessed by interview and self-report and the primary outcome is frequency. Frequency will be defined continuously (analyzed dimensionally).
Post-treatment (4 months)
Body Mass Index (Percent Weight Loss)
BMI is calculated using measured height and weight. Percent weight loss, where negative values represent proportional weight loss, is calculated as the difference between weight at post-treatment and baseline weight, divided by baseline weight. By definition, all participants have 0% weight loss at baseline.
Post-treatment (4 months)
Secondary Outcomes (1)
Number of Participants Meeting Response Criteria
Post-treatment (4 months)
Study Arms (4)
BWL + NB medication
EXPERIMENTALParticipants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
BWL + Placebo
EXPERIMENTALParticipants randomly assigned to this arm will receive 16 weeks of Behavioral Weight Loss (BWL) counseling and placebo. Placebo will be inactive and taken daily in pill form.
NB medication
EXPERIMENTALParticipants randomly assigned to this arm will receive 16 weeks of NB medication. NB medication will combine naltrexone sustained-release (SR, 32 mg/day) combined with bupropion SR (360 mg/day) taken daily in pill form.
Placebo
PLACEBO COMPARATORParticipants randomly assigned to this arm will receive 16 weeks of placebo. Placebo will be inactive and taken daily in pill form.
Interventions
NB medication
Eligibility Criteria
You may qualify if:
- Binge eating disorder (full criteria as described in the American Psychiatric Association Diagnostic and Statistical Manual of Mental Disorders, 5th edition)
- BMI 27-30 with a controlled obesity-related co-morbidity; or BMI ≥ 30 and \<50;
- Available for the duration of the treatment and follow-up (20 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.
You may not qualify if:
- Currently taking anti-depressant medications;
- Currently taking opioid pain medications or drugs;
- Currently taking medications that influence eating/weight;
- History of seizures;
- Current substance use disorder or other severe psychiatric disturbance (e.g., suicidality);
- Past or current anorexia nervosa, bulimia nervosa;
- Pregnant or breastfeeding;
- Medical status judged by study physician as contraindication.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Yale School of Medicine
New Haven, Connecticut, 06520, United States
Related Publications (1)
Grilo CM, Lydecker JA, Fineberg SK, Moreno JO, Ivezaj V, Gueorguieva R. Naltrexone-Bupropion and Behavior Therapy, Alone and Combined, for Binge-Eating Disorder: Randomized Double-Blind Placebo-Controlled Trial. Am J Psychiatry. 2022 Dec 1;179(12):927-937. doi: 10.1176/appi.ajp.20220267. Epub 2022 Oct 26.
PMID: 36285406DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Carlos Grilo
- Organization
- Yale University
Study Officials
- PRINCIPAL INVESTIGATOR
Carlos Grilo, PhD
Yale University
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2017
First Posted
February 7, 2017
Study Start
February 27, 2017
Primary Completion
July 23, 2021
Study Completion
December 16, 2022
Last Updated
March 8, 2023
Results First Posted
December 20, 2022
Record last verified: 2023-03