Status:
COMPLETED
Enhancing the Effects of Alcohol Treatment With Lamotrigine
Lead Sponsor:
Brown University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Rhode Island Hospital
Conditions:
Alcohol Use Disorder
Eligibility:
All Genders
16-24 years
Phase:
PHASE2
Brief 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 lamotrig...
Detailed Description
Adolescent alcohol use is a leading public health concern worldwide. Clinical trials have tested a variety of psychosocial interventions with youth that yield only modest short-term benefits. One pote...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 24 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04770493
Start Date
January 24 2022
End Date
October 24 2024
Last Update
June 13 2025
Active Locations (1)
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1
Brown University Center for Alcohol and Addiction Studies
Providence, Rhode Island, United States, 02903