Enhancing the Effects of Alcohol Treatment With Lamotrigine

NCT ID: NCT04770493

Last Updated: 2025-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-24
• Study Completion Date: 2024-10-24

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 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.

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 potential way to improve treatments is to augment psychosocial interventions with pharmacotherapy. The National Institutes of Health has mounted a concerted effort to identify medications that reduce drinking for nearly three decades. Although this effort improved treatment for adults, no medication is indicated for adolescent use and randomized controlled trials with teenagers are almost nonexistent. This gap raises key questions about whether and how medications could benefit youth. Optimizing treatment options for youth requires closing this important gap. Lamotrigine is safe with adolescents and does not adversely interact with alcohol. Lamotrigine targets brain mechanisms implicated in alcohol use disorder, and it has shown to help treat adults with alcohol problems. Yet, despite its widespread use with children and adolescents, no published double-blind, placebo-controlled studies have examined the effects of lamotrigine on drinking-related behavior in youth. The purpose of this study is to determine how well teenagers accept lamotrigine plus alcohol education to reduce adolescent alcohol use. This study will also tell us whether teenagers' alcohol use, craving, and enjoyment of drinking are reduced by lamotrigine.

Conditions

Alcohol Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Lamotrigine

Lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks

Group Type: EXPERIMENTAL

Lamotrigine

Intervention Type: DRUG

Participants will be randomized to lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks. A comparator group will receive placebo (sugar pills).

Placebo

Identical matching placebo capsules

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo (sugar pill)

Interventions

Lamotrigine

Participants will be randomized to lamotrigine (25 mg/day to 200 mg/day in two divided doses) for 9 weeks. A comparator group will receive placebo (sugar pills).

Intervention Type: DRUG

Placebo

Matching placebo (sugar pill)

Intervention Type: DRUG

Other Intervention Names

Lamictal

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Rhode Island Hospital

OTHER

Sponsor Role: collaborator

Brown University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Miranda, PhD

Role: PRINCIPAL_INVESTIGATOR

Brown University

Locations

Brown University Center for Alcohol and Addiction Studies

Providence, Rhode Island, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R21AA028394

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2004002676

Identifier Type: -

Identifier Source: org_study_id