CompletedPhase 2

Enhancing the Effects of Alcohol Treatment With Lamotrigine

United States44 participantsStarted 2022-01-24

Plain-language 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.

Who can participate

Age range

16 Years – 24 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 16 to 24 years old, inclusive * 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 * Meet the DSM-5 criteria for alcohol use disorder (AUD) * Be interested in reducing alcohol use * Be able to read simple English * 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. Exclusion Criteria: * Currently receiving formal AUD treatment * Significant alcohol withdrawal symptoms * Coexisting moderate or severe substance use disorder other than cannabis and nicotine, as defined by DSM-5 criteria. * Positive urine toxicology screen any substances other than cannabis (THC) * Currently taking a pharmacotherapy for AUD, a carbonic anhydrase inhibitor, or a glucuronidation * Compelled to alcohol treatment by the justice system or has probation or parole requirements that might interfere with study participation * History of rash that was serious, required hospitalization, or related to lamotrigine * Have a history of any serious, unstable medical illness including seizures or hepatic, renal, gastroenterol…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Completion Rates

Timeframe: 9-week active treatment phase

Acceptability of the Study Medication

Timeframe: 9-week active treatment phase

Trial details

NCT IDNCT04770493

SponsorBrown University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-10-24

Results submitted2025-04-16

View on ClinicalTrials.gov More Alcohol Use Disorder trials