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.

Must not have

A history of Steven-Johnson syndrome or any presentation of symptoms suggestive of Steven-Johnson syndrome.

Current or lifetime history of psychosis or suicidality

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9-week active treatment phase

Summary

This trial is testing lamotrigine, a medication that stabilizes mood, in teenagers who have problems with alcohol. The goal is to see if it can help reduce their drinking and cravings. Lamotrigine works by balancing brain chemicals that affect mood and behavior. It is known for its efficacy in treating bipolar disorder, particularly in managing depressive symptoms.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had Steven-Johnson syndrome or symptoms like it.

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I have a history of psychosis or suicidal thoughts or actions.

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My kidney tests (BUN and creatinine) show they are not working well.

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I am currently on medication for alcohol use disorder, or taking a carbonic anhydrase inhibitor or a drug that affects glucuronidation.

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I am not taking medications like Depakote, carbamazepine, or rifampin.

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I have kidney or liver problems.

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I have been treated with lamotrigine before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Acceptability of the study medication

Completion rates

Secondary study objectives

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 / 10Eligibility 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.