Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-25 @ 1:21 AM
NCT ID:
NCT04770493
Eligibility Criteria:
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, 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
24 Years
Study:
NCT04770493
Study Brief:
Protocol Section:
NCT04770493