CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 66 enrolled
Drug / intervention
Lacosamide +1 moredrug
Likely dose
Lacosamide 300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03271528
NCT03271528Phase 1Completed

Lacosamide Effects on Alcohol Self Administration and Craving in Heavy Drinkers

Boston Medical Center·interventional·Posted Sep 5, 2017·Updated Jun 3, 2021

In Brief

A Phase 1 clinical trial evaluating Lacosamide and Placebo oral capsule for Alcohol Use Disorder. Completed, enrolled 66 participants across 1 site.

Detailed Summary

This is a double-blind, randomized, placebo-controlled, crossover design trial tested the effect of lacosamide on alcohol self-administration and craving following a priming dose of alcohol. The specific objective of this study was to determine whether lacosamide, a novel anticonvulsant that is FDA-approved for treating partial seizures, has effects on alcohol craving and consumption.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
201820192020202120222023202420252026
First PostedSep 5, 2017
Enrollment StartApr 15, 2018
Primary CompletionAug 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 8.8 years ago

Interventions

Lacosamidedrug

Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.

Placebo oral capsuledrug

Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.