What is the mechanism of action of this treatment?

Common treatments for alcoholism work by modulating neurotransmitter activity to restore balance disrupted by chronic alcohol use. Lamotrigine, a mood-stabilizing anticonvulsant, inhibits voltage-sensitive sodium channels, reducing the release of excitatory neurotransmitters like glutamate. Similarly, naltrexone blocks opioid receptors to diminish alcohol's rewarding effects, while acamprosate modulates glutamatergic neurotransmission to ease withdrawal symptoms. These mechanisms are vital for tailoring treatments to address specific neurochemical imbalances in alcoholism patients, improving their chances of recovery.

What side effects are associated with this type of intervention?

Lamotrigine, a mood-stabilizing anticonvulsant, is associated with several side effects, including nausea, dyspepsia, sedation, and nonserious skin rash. A rare but serious side effect is severe cutaneous hypersensitivity, which necessitates slow dose titration to mitigate risk. Other common side effects include dizziness and headaches. Similar treatments for alcoholism, such as other anticonvulsants, may also cause gastrointestinal disturbances, dizziness, and sedation.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of alcoholism, primarily focusing on modulating neurotransmitter activity. These include disulfiram, which inhibits the enzyme acetaldehyde dehydrogenase, leading to unpleasant effects when alcohol is consumed; naltrexone, an opioid receptor antagonist that reduces the rewarding effects of alcohol; and acamprosate, which modulates glutamatergic neurotransmission to reduce cravings. While Lamotrigine, a mood-stabilizing anticonvulsant, is being studied for its potential benefits in treating alcohol use disorder, it has not yet received FDA approval for this indication.

What other types of research exist?

Promising novel alternatives to Lamotrigine for alcoholism treatment in 2024 include Naltrexone, Acamprosate, and Gabapentin. Naltrexone and Acamprosate are well-established treatments that modulate neurotransmitter systems involved in alcohol dependence. Gabapentin, an anticonvulsant, has shown efficacy in reducing alcohol consumption and withdrawal symptoms in recent studies.

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Anticonvulsant

Lamotrigine for Alcohol Use Disorder

Phase 2

Recruiting

Led By Robert Miranda, PhD

Research Sponsored by Brown University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9-week active treatment phase

Awards & highlights

Study Summary

This trial will help determine if lamotrigine, a mood-stabilizing anticonvulsant, is an effective treatment for alcohol use disorder in young people, and if it improves outcomes related to alcohol use.

Who is the study for?

This trial is for young people aged 16-19 with alcohol use disorder who want to cut down on drinking. They must meet specific criteria for binge drinking and agree to use condoms if they're sexually active females on oral contraceptives. It's not open to those already in AUD treatment, with certain medical conditions or taking conflicting medications.Check my eligibility

What is being tested?

The study tests the mood-stabilizer Lamotrigine against a placebo to see if it can help youth reduce their alcohol consumption. Participants will be randomly assigned to either receive Lamotrigine or a placebo, allowing researchers to compare outcomes between the two groups.See study design

What are the potential side effects?

Lamotrigine may cause side effects like skin rashes (potentially serious), dizziness, headaches, blurred vision, nausea, and tiredness. There's also a risk of more severe reactions such as Steven-Johnson syndrome but these are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been binge drinking at least 5 days in the last 3 months.

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I agree to use condoms as birth control because I'm on estrogen-based oral contraceptives.

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I am between 16 and 19 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9-week active treatment phase

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9-week active treatment phase

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9-week active treatment phase for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the study medication

Completion rates

Secondary outcome measures

Alcohol craving

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LamotrigineExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Identical matching placebo capsules

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lamotrigine

2011

Completed Phase 4

~2490

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for alcoholism work by modulating neurotransmitter activity to restore balance disrupted by chronic alcohol use. Lamotrigine, a mood-stabilizing anticonvulsant, inhibits voltage-sensitive sodium channels, reducing the release of excitatory neurotransmitters like glutamate. Similarly, naltrexone blocks opioid receptors to diminish alcohol's rewarding effects, while acamprosate modulates glutamatergic neurotransmission to ease withdrawal symptoms. These mechanisms are vital for tailoring treatments to address specific neurochemical imbalances in alcoholism patients, improving their chances of recovery.