Phase
Condition
Alcohol Dependence
Alcohol Use Disorder
Addictions
Treatment
Lamotrigine
Placebo
Clinical Study ID
Ages 16-24 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 boysand ≥ 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 usesecondary methods of birth control, such as condoms because lamotrigine lowers theeffectiveness of estrogen-containing oral contraceptives. Sexually active femalescannot be in this study if they do not agree to use a barrier method of birthcontrol (condom) every time they engage in sexual intercourse.
Exclusion
Exclusion Criteria:
Currently receiving formal AUD treatment
Significant alcohol withdrawal symptoms
Coexisting moderate or severe substance use disorder other than cannabis andnicotine, 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 aglucuronidation
Compelled to alcohol treatment by the justice system or has probation or parolerequirements that might interfere with study participation
History of rash that was serious, required hospitalization, or related tolamotrigine
Have a history of any serious, unstable medical illness including seizures orhepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic,neurologic, immunologic, or hematologic disease
Clinically significant abnormal liver function tests, including elevation of liverenzymes (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 careprofessional) 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 ofSteven-Johnson syndrome.
Current or lifetime history of psychosis or suicidality
Study Design
Study Description
Connect with a study center
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island 02903
United StatesSite Not Available

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