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

NCT03897348 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2022-06-28

Study results available
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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.

Conditions

Interventions

DRUG

Placebo

Oral medication

DRUG

Lacosamide 100 mg

Oral medication

DRUG

Lacosamide 200 mg

Oral medication

Sponsors & Collaborators

Principal Investigators

  • Steven L. Batki, MD · UCSF/SFVAHCS/NCIRE

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-17
Primary Completion
2019-06-12
Completion
2019-06-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03897348 on ClinicalTrials.gov