Enhancing the Effects of Alcohol Treatment With Lamotrigine

• Status: Not yet recruiting
• Trial end date: 2023-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brown University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Lamotrigine

Criteria

Inclusion Criteria:

• 16 to 19 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