Enhancing the Effects of Alcohol Treatment With Lamotrigine (NCT04770493) | Clinical Trial Compass
CompletedPhase 2
Enhancing the Effects of Alcohol Treatment With Lamotrigine
United States44 participantsStarted 2022-01-24
Plain-language 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.
Who can participate
Age range16 Years – 24 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, gastroenterol…