Enhancing the Effects of Alcohol Treatment With Lamotrigine

NCT04770493 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2004002676R21AA028394
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder

Keywords

Alcohol; Teenager; Medication; Clinical Trial

Outcome Measures

Primary Outcomes (2)

• Completion Rates

  The number and percentage of youth who complete the active medication phase will determine feasibility.

  9-week active treatment phase

• Acceptability of the Study Medication

  The Client Satisfaction Questionnaire (CSQ-8) ranges from 8 to 32 (higher scores indicate higher satisfaction) and will determine acceptability. Treatment satisfaction will be considered acceptable if the number and percentage of subjects who rate their treatment experience in the "satisfactory" or "highly satisfactory" ranges on the CSQ-8 is equal to or greater than 80%.

  9-week active treatment phase

Secondary Outcomes (1)

• Alcohol Craving

  9-week active treatment phase

Study Arms (2)

Lamotrigine

EXPERIMENTAL

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

Drug: Lamotrigine

Placebo

PLACEBO COMPARATOR

Identical matching placebo capsules

Drug: Placebo

Interventions

Lamotrigine 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).

Also known as: Lamictal

Lamotrigine

Placebo DRUG

Matching placebo (sugar pill)

Placebo

Eligibility Criteria

• Age: 16 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brown University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Rhode Island Hospital: collaborator

Study Sites (1)

Brown University Center for Alcohol and Addiction Studies

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Robert Miranda Jr.
• Organization: Brown University

Robert_Miranda_Jr@brown.edu

401-863-6658

Study Officials

• Robert Miranda, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: February 25, 2021
• Study Start: January 24, 2022
• Primary Completion: October 24, 2023
• Study Completion: October 24, 2024
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: One year after the completion of the project.
• Access Criteria: As required by the Sponsor, the data from this clinical trial will be uploaded to the National Institute on Alcohol Abuse and Alcoholism (NIAAA) data repository. Like all NIAAA grants, the NIAAA will govern the access criteria.

Locations

US (1)