CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 44 enrolled
Drug / intervention
Lamotrigine +1 moredrug
Likely dose
Lamotrigine 25 mgfrom 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/NCT04770493
NCT04770493Phase 2Completed
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Proof-of-Concept Clinical Trial of Lamotrigine as a Candidate Pharmacotherapy for Adolescent Alcohol Use Disorder

Brown University·interventional·Posted Feb 25, 2021·Updated Jun 13, 2025

In Brief

A Phase 2 clinical trial evaluating Lamotrigine and Placebo for Alcohol Use Disorder. Completed, enrolled 44 participants across 1 site.

Detailed Summary

This study will help determine the tolerability and efficacy of the mood-stabilizing anticonvulsant lamotrigine in youth with alcohol use disorder. It will also help establish whether and how lamotrigine improves outcomes related to alcohol use. The results of this proof-of-concept study will inform whether a future larger clinical trial is warranted.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlcohol Use Disorder
CountriesUnited States
CollaboratorsNational Institute on Alcohol Abuse and Alcoholism (NIAAA), Rhode Island Hospital

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedFeb 25, 2021
Enrollment StartJan 24, 2022
Primary CompletionOct 24, 2023
Study CompletionOct 24, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 5.4 years ago

Interventions

Lamotriginedrug

Participants will be randomized to lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks. A comparator group will receive placebo (sugar pills).

Placebodrug

Matching placebo (sugar pill)