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

Alcohol Use Disorder Clinical Trial

Official title:
A Pilot Placebo-controlled Human Laboratory Feasibility Study of Lacosamide Effects in Alcohol Use Disorder

Clinical Trial 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.

Clinical Trial Description

Four heavy-drinking non-treatment seeking male community volunteers with a diagnosis of AUD will undergo 3 ADP sessions. In each of the 3 ADP sessions, they will receive one of the following 3 different interventions: either 100 mg of lacosamide, 200 mg of lacosamide or placebo. The ADP session is a one day human laboratory session at the SFVA Medical Center. This human laboratory session involves the self-administration of alcoholic beverages by research participants under highly structured, observed conditions in order to evaluate the effects of the study drug interventions (either 100 mg lacosamide, 200 mg lacosamide, or placebo) on alcohol craving and alcohol consumption. The study follows a double-blind placebo-controlled crossover design in which each participant receives each of the 3 drug interventions in a randomly assigned sequence. There were 4 possible sequences representing the 4 arms of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03897348
Study type Interventional
Source University of California, San Francisco
Contact
Status Completed
Phase Phase 2
Start date September 17, 2018
Completion date June 12, 2019
View Details
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