Enhancing the Effects of Alcohol Treatment With Lamotrigine

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Use Disorder

In brief

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.

Key facts

Study ID

NCT04770493

Run by

Brown University

People needed

44

Starts

2022-01-24

Expected to finish

2024-10-24

Last updated by the study team

2025-06-13

Who can join

Age: 16 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease
• Clinically significant abnormal liver function tests, including elevation of liver enzymes (AST, ALT) 3-fold above the upper limit of normal.
• Abnormal BUN and creatinine for renal impairment
• Renal or hepatic impairment
• Clinically significant abnormalities per physical exam, hematological assessment, bilirubin concentration, or urinalysis
• Pregnant, nursing, or refusing to use a condom, if female.
• Used psychotropic or anticonvulsant medication (prescribed by a health care professional) in the past 30 days (e.g., topiramate)
• Taking medications contraindicated with lamotrigine (e.g., valproate acid [Depakote], carbamazepine, phenytoin, phenobarbital, primidone, and rifampin, protease inhibitors lopinavir/ritonavir and atazanavir/lopinavi
• History of prior treatment with lamotrigine
• Known sensitivity or allergy to lamotrigine
• A previous history of drug reaction with eosinophilia and systemic symptoms (DRESS) or blood dyscrasias
• A history of Steven-Johnson syndrome or any presentation of symptoms suggestive of Steven-Johnson syndrome.
• Current or lifetime history of psychosis or suicidality

Where it is running

• Brown University Center for Alcohol and Addiction Studies — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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