Phase 2
Completed N=44
Enhancing the Effects of Alcohol Treatment With Lamotrigine
Source: ClinicalTrials.gov NCT04770493 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Completion Rates — 22; 19 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Completion Rates |
22; 19 | — |
| PRIMARY Acceptability of the Study Medication |
20; 19 | — |
| SECONDARY Alcohol Craving |
3.14; 3.81 | — |
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
Data sourced from ClinicalTrials.gov (NCT04770493). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.