Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04599478
Status:
RECRUITING
Last Update Posted:
2023-08-31
First Post:
2020-10-21
Brief Title:
Pharmacological and Behavioral Treatment After Bariatric Surgery Acute Stage 1
Sponsor:
Yale University
Organization:
Yale University
Study Overview
Official Title:
Pharmacological and Behavioral Treatments to Treat Loss-of-Control Eating and Improve Weight Outcomes After Bariatric Surgery Acute Stage 1
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will compare the effectiveness of behavioral and pharmacologic treatments alone and in combination for the treatment of loss-of-control eating and weight following bariatric surgery This is an acute treatment comparing behavioral weight loss alone or in combination with combination naltrexonebupropion medication
Detailed Description:
Participants who provide informed consent and are determined to be eligible will then participate in the study
A total of 160 patients with obesity and regular LOC-eating following MBS will be randomly assigned double-blind in a balanced factorial 2 X 2 design to one of four 16-week interventions BWLNB BWLPlacebo NB or Placebo The randomization will be in equal proportions but stratified by surgery type
A total of 160 patients with obesity and regular LOC-eating following MBS will be randomly assigned double-blind in a balanced factorial 2 X 2 design to one of four 16-week interventions BWLNB BWLPlacebo NB or Placebo The randomization will be in equal proportions but stratified by surgery type
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DK126637-01 | NIH | None | httpsreporternihgovquickSearchR01DK126637-01 |