Ignite Creation Date:
2024-05-06 @ 7:06 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05892432
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-05-26
Brief Title:
Clinical Trial of Rybelsus semaglutide Among Adults with Alcohol Use Disorder AUD
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Randomized Controlled Trial of Rybelsus semaglutide Among Adults with Alcohol Use Disorder AUD
Status:
RECRUITING
Status Verified Date:
2024-01
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 is a randomized controlled trial of oral semaglutide among treatment-seeking individuals with AUD The investigators will randomly assign 50 participants to receive semaglutide titrated to 7 milligrams mg per day or matched placebo for 8 weeks The primary aims are to assess the safety and tolerability of semaglutide in this population and to evaluate its effects relative to placebo on alcohol cue-elicited craving and alcohol consumption
Detailed Description:
A screening visit will be conducted at which written informed consent will be obtained and inclusionexclusion criteria will be assessed Subsequently eligible participants will be randomly assigned to take oral semaglutide or matched placebo for 8 weeks with the semaglutide dose titrated from 3 milligrams mgday for the first 4 weeks to 7 milligrams mgday for the second 4 weeks Participants will complete 7 additional clinic visits weekly during the first 4 weeks of the treatment period and biweekly during the second 4 weeks At each visit participants will also engage in a computerized behavioral intervention At screening and again at the Week 6 visit participants will complete an alcohol cue reactivity task At the Week 1 visit before ingesting the first dose of study medication and again at the Week 8 visit participants will complete a functional MRI session
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 |
|---|---|---|---|
| R21AA031146 | NIH | None | httpsreporternihgovquickSearchR21AA031146 |