Study Summary
This trial will compare how well two types of treatment, behavioral and pharmacologic, work when used alone or together to help people lose weight, improve cardiovascular risk factors, and function better socially after bariatric surgery.
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: From post-treatment (6-months) to the 12-month follow-up
From post-treatment (6-months) to the 12-month follow-up
Change in Body Mass Index (BMI)
Change in Depressive Symptoms
Change in Eating Disorder Psychopathology
Change in Food Craving
Change in Glucose
Change in HbA1C
Change in Loss-of-Control Eating Frequency
Change in Total cholesterol
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
4 Treatment Groups
NB medication
1 of 4
BWL + Placebo
1 of 4
BWL + NB medication
1 of 4
Placebo
1 of 4
Experimental Treatment
Non-Treatment Group
160 Total Participants · 4 Treatment Groups
Primary Treatment: Naltrexone and Bupropion Combination · Has Placebo Group · Phase 2 & 3
NB medication
Drug
Experimental Group · 1 Intervention: Naltrexone and Bupropion Combination · Intervention Types: DrugBWL + PlaceboExperimental Group · 2 Interventions: Behavioral Weight Loss, Placebo · Intervention Types: Behavioral, Other
BWL + NB medicationExperimental Group · 2 Interventions: Naltrexone and Bupropion Combination, Behavioral Weight Loss · Intervention Types: Drug, Behavioral
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Behavioral Weight Loss
2011
N/A
~320
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from post-treatment (6-months) to the 12-month follow-up
Who is running the clinical trial?
Yale UniversityLead Sponsor
1,678 Previous Clinical Trials
21,087,653 Total Patients Enrolled
58 Trials studying Obesity
248,032 Patients Enrolled for Obesity
Valentina Ivezaj, Ph.D.Principal InvestigatorYale School of Medicine
2 Previous Clinical Trials
133 Total Patients Enrolled
Eligibility Criteria
Age 18 - 70 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are able to read, comprehend, and write English at a sufficient level to complete study-related materials.
You are a female of reproductive potential.
You are willing to comply with all study procedures and are available for the duration of the study.
You are of reproductive potential.\n
You have had laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy.
Who else is applying?
What state do they live in?
| Texas | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Yale School of Medicine | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
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Conditions
Cancer Related
Treatments