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NCT03897348 · ClinicalTrials.gov registry record · Phase 2

Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD)

A Phase 2 study, sponsored by University of California, San Francisco.

Completed
Registry status
Phase 2
Development phase
4
Enrollment target

NCT03897348: Completed Phase 2 study, sponsored by University of California, San Francisco.

NCT03897348 is a Phase 2 study that has completed, run by University of California, San Francisco. The registered enrollment target is 4 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03897348, a Phase 2 study, has completed, sponsored by University of California, San Francisco.

COMPLETED
Registry status
Phase 2
Development phase
4 participants
Enrollment target

Study Summary

The overall goal of the proposed project is to improve the treatment of individuals with AUD. The investigators will conduct the first pilot human laboratory study to assess the effects of two doses of lacosamide on alcohol drinking and craving. The investigators will assess its effects on reducing alcohol intake using a human laboratory method, the Yale Alcohol Drinking Paradigm (ADP). The investigators will also assess the feasibility of the Alcohol Drinking Paradigm (ADP) in order to position our research team to have the capacity to conduct future, larger, hypothesis-testing human laboratory-based experiments designed to test the efficacy of potential alcohol treatments.

Primary Outcome

Recruitment feasibility will be measured as the time (in months) required to recruit, screen and conduct the study procedures for a total of 4 participants.

Interventions

  • DRUG Placebo
  • DRUG Lacosamide 100 mg
  • DRUG Lacosamide 200 mg

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2018-09-17
Est. Completion 2019-06-12
Phase Phase 2

What the finished NCT03897348 record still lists

NCT03897348 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.

NCT03897348 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03897348 about?

NCT03897348 is a clinical study titled "Pilot Human Lab Study of Lacosamide in Alcohol Use Disorder (AUD)". The overall goal of the proposed project is to improve the treatment of individuals with AUD. The investigators will conduct the first pilot human laboratory study to assess the effects of two doses of lacosamide on alcohol drinking and craving. The investigators will assess its effects on reducing ...

What is the current status of trial NCT03897348?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2018-09-17. Estimated completion is 2019-06-12.

What interventions are being tested in trial NCT03897348?

The interventions under investigation include: Placebo (DRUG), Lacosamide 100 mg (DRUG), Lacosamide 200 mg (DRUG).

Who is sponsoring clinical trial NCT03897348?

This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03897348's enrollment target sits among peer trials

4 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03897348, the US trial registry maintained by the National Library of Medicine. NCT03897348 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.