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Anticonvulsant

Lamotrigine for Alcohol Use Disorder

Phase 2

Recruiting

Led By Robert Miranda, PhD

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reports consuming alcohol ≥ 2 days/week on average in the past 90 days of which ≥ 5 days involved ≥ 4 drinks within a 2-hr period (i.e., binge drinking) for boys and ≥ 3 drinks for girls

Females taking estrogen-containing oral contraceptives have to agree to use secondary methods of birth control, such as condoms because lamotrigine lowers the effectiveness of estrogen-containing oral contraceptives. Sexually active females cannot be in this study if they do not agree to use a barrier method of birth control (condom) every time they engage in sexual intercourse.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9-week active treatment phase

Awards & highlights

Study Summary

This trial will help determine if lamotrigine, a mood-stabilizing anticonvulsant, is an effective treatment for alcohol use disorder in young people, and if it improves outcomes related to alcohol use.

Who is the study for?

This trial is for young people aged 16-19 with alcohol use disorder who want to cut down on drinking. They must meet specific criteria for binge drinking and agree to use condoms if they're sexually active females on oral contraceptives. It's not open to those already in AUD treatment, with certain medical conditions or taking conflicting medications.Check my eligibility

What is being tested?

The study tests the mood-stabilizer Lamotrigine against a placebo to see if it can help youth reduce their alcohol consumption. Participants will be randomly assigned to either receive Lamotrigine or a placebo, allowing researchers to compare outcomes between the two groups.See study design

What are the potential side effects?

Lamotrigine may cause side effects like skin rashes (potentially serious), dizziness, headaches, blurred vision, nausea, and tiredness. There's also a risk of more severe reactions such as Steven-Johnson syndrome but these are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been binge drinking at least 5 days in the last 3 months.

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I agree to use condoms as birth control because I'm on estrogen-based oral contraceptives.

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I am between 16 and 19 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9-week active treatment phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9-week active treatment phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9-week active treatment phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the study medication

Completion rates

Secondary outcome measures

Alcohol craving

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LamotrigineExperimental Treatment1 Intervention

Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks

Group II: PlaceboPlacebo Group1 Intervention

Identical matching placebo capsules

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lamotrigine

2011

Completed Phase 4

~2490

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brown UniversityLead Sponsor

456 Previous Clinical Trials

558,304 Total Patients Enrolled

29 Trials studying Alcoholism

5,465 Patients Enrolled for Alcoholism

National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH

801 Previous Clinical Trials

1,365,347 Total Patients Enrolled

423 Trials studying Alcoholism

985,658 Patients Enrolled for Alcoholism

Rhode Island HospitalOTHER

260 Previous Clinical Trials

66,957 Total Patients Enrolled

5 Trials studying Alcoholism

750 Patients Enrolled for Alcoholism

Media Library

Lamotrigine (Anticonvulsant) Clinical Trial Eligibility Overview. Trial Name: NCT04770493 — Phase 2

Alcoholism Research Study Groups: Lamotrigine, Placebo

Alcoholism Clinical Trial 2023: Lamotrigine Highlights & Side Effects. Trial Name: NCT04770493 — Phase 2

Lamotrigine (Anticonvulsant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04770493 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still openings for participation in this trial?

"Evidentiary data on clinicaltrials.gov reveals that this medical study, which was first opened to the public on January 24th 2022, is currently seeking participants. The trial has been revised as of April 21st 2022."

Answered by AI

Has Lamotrigine been authenticated by the Food and Drug Administration?

"The safety rating of Lamotrigine was assigned a 2 on the 1-3 scale due to existing data that supports its security, yet no evidence demonstrated efficacy."

Answered by AI

Would I be eligible to partake in this medical study?

"Eligibility criteria for this research trial require that participants must be alcohol-dependent and fall between the ages of 16 and 19. Currently, roughly 50 people are needed to fulfil study requirements."

Answered by AI

What is the scope of participation for this experiment?

"Accurately, the details on clinicaltrials.gov demonstrate that this study is still searching for participants. It was initially posted to the website on January 24th 2022 and its most recent update happened April 21st 2022. The experiment requires 50 patients at one location."

Answered by AI

Is enrollment available for those aged fifty and beyond in this investigation?

"To be eligible for inclusion in this medical trial, prospective patients must fall between 16 and 19 years old. Furthermore, 35 clinical trials are available to those younger than 18 while 253 studies focus on the elderly population of over 65s."

Answered by AI

What specific medical conditions may be alleviated by Lamotrigine?

"Lamotrigine is typically prescribed to ameliorate symptoms associated with Lennox Gastaut Syndrome. It can also be utilized in the treatment of bipolar disorder, conversion to monotherapy and other conditions that require standardized therapy regimes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Enhancing the Effects of Alcohol Treatment With Lamotrigine

2022. "Enhancing the Effects of Alcohol Treatment With Lamotrigine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04770493.

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