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NCT06471686 · ClinicalTrials.gov registry record · Phase 2
Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations
A Phase 2 study, sponsored by University of Southern California.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT06471686 is a Phase 2 study that has completed, run by University of Southern California. The registered enrollment target is 30 participants.
The verdict
NCT06471686, a Phase 2 study, has completed, sponsored by University of Southern California.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study 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 2:1 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 use\>60%), and efficacy (reduction in Penn Alcohol Craving Scale \[PACS\]) and relapse). Relapse was defined as blood phosphatidylethanol≥20ng/mL or reported alcohol use. All analyses were done in the intention to treat (ITT) population and per-protocol population (PPP) (excluding withdrawals/acamprosate non-adherent).
Interventions
- DRUG Acamprosate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-12-01 |
| Est. Completion | 2023-10-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06471686
The ClinicalTrials.gov registry entry for NCT06471686 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Southern California, which has 617 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Acamprosate is the first listed.
NCT06471686 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06471686 about?
NCT06471686 is a clinical study titled "Safety of Acamprosate in Treating Alcohol Use Disorder in the Post Liver Transplant Populations". 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 enrolle...
What is the current status of trial NCT06471686?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-12-01. Estimated completion is 2023-10-30.
What interventions are being tested in trial NCT06471686?
The interventions under investigation include: Acamprosate (DRUG).
Who is sponsoring clinical trial NCT06471686?
This trial is sponsored by University of Southern California, which has 617 total clinical trials registered on ClinicalTrials.gov.
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