Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06471686
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2024-06-10
Brief Title:
Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations
Sponsor:
University of Southern California
Organization:
University of Southern California
Study Overview
Official Title:
Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations
Status:
COMPLETED
Status Verified Date:
2024-06
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:
Acamprosate for alcohol use disorder may benefit liver transplant LT recipients with alcohol-associated liver disease ALD yet data on feasibility and safety in LT recipients are lacking This was a single-center unblinded randomized controlled trial of adults 18 years with LT for ALD enrolled between 2021-2023 who were randomized 21 to the intervention of acamprosate 666mg dose three time daily or standard of care SOC for 14 weeks The primary outcome was safety prevalence of adverse events AE Secondary outcomes included feasibility weekly survey response rate 60 adherence self reported acamprosate use60 and efficacy reduction in Penn Alcohol Craving Scale PACS and relapse Relapse was defined as blood phosphatidylethanol20ngmL or reported alcohol use All analyses were done in the intention to treat ITT population and per-protocol population PPP excluding withdrawalsacamprosate non-adherent
Detailed Description:
Acamprosate for alcohol use disorder may benefit liver transplant LT recipients with alcohol-associated liver disease ALD yet data on feasibility and safety in LT recipients are lacking
This was a single-center unblinded randomized controlled trial of adults 18 years with LT for ALD enrolled between 2021-2023 who were randomized 21 to the intervention of acamprosate 666mg dose three time daily or standard of care SOC for 14 weeks The primary outcome was safety prevalence of adverse events AE Secondary outcomes included feasibility weekly survey response rate 60 adherence self reported acamprosate use60 and efficacy reduction in Penn Alcohol Craving Scale PACS and relapse Relapse was defined as blood phosphatidylethanol20ngmL or reported alcohol use All analyses were done in the intention to treat ITT population and per-protocol population PPP excluding withdrawalsacamprosate non-adherent
This was a single-center unblinded randomized controlled trial of adults 18 years with LT for ALD enrolled between 2021-2023 who were randomized 21 to the intervention of acamprosate 666mg dose three time daily or standard of care SOC for 14 weeks The primary outcome was safety prevalence of adverse events AE Secondary outcomes included feasibility weekly survey response rate 60 adherence self reported acamprosate use60 and efficacy reduction in Penn Alcohol Craving Scale PACS and relapse Relapse was defined as blood phosphatidylethanol20ngmL or reported alcohol use All analyses were done in the intention to treat ITT population and per-protocol population PPP excluding withdrawalsacamprosate non-adherent
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