What side effects are associated with this type of intervention?

Common treatments for alcoholism include medications like disulfiram, naltrexone, and acamprosate. Disulfiram can cause side effects such as drowsiness, headache, and a metallic taste, and it can lead to severe reactions if alcohol is consumed. Naltrexone may cause nausea, headache, dizziness, and fatigue. Acamprosate's side effects include diarrhea, anxiety, and insomnia. For treatments similar to Acetyl-L-carnitine (ALCAR), which focuses on mitochondrial function and energy metabolism, side effects are generally mild and may include gastrointestinal discomfort, nausea, and headache. It is important to consult with a healthcare provider to tailor the treatment plan to individual needs and monitor for any adverse effects.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of alcoholism, including disulfiram, naltrexone, and acamprosate. Disulfiram works by causing unpleasant effects when alcohol is consumed, naltrexone reduces the euphoric effects and cravings for alcohol, and acamprosate helps to stabilize the chemical balance in the brain that would otherwise be disrupted by alcohol withdrawal. While these treatments do not specifically target mitochondrial function and energy metabolism like Acetyl-L-carnitine (ALCAR), they are the primary pharmacological options currently approved for managing alcohol use disorder.

What other types of research exist?

Promising novel alternatives to Acetyl-L-carnitine (ALCAR) for alcoholism treatment include: 1) Sodium Oxybate, which has shown efficacy in reducing alcohol cravings and withdrawal symptoms. 2) Baclofen, a GABA-B receptor agonist, which has been effective in reducing alcohol consumption and cravings. 3) N-acetylcysteine (NAC), which helps in reducing oxidative stress and has shown potential in reducing alcohol use. 4) Topiramate, an anticonvulsant that has shown promise in reducing heavy drinking days and increasing abstinence rates.

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Amino Acid

Acetyl-L-Carnitine for Alcoholism

Phase 1

Waitlist Available

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

Be able to take oral medication and be willing to adhere to the medication regimen

Be 14 to 20 years old, inclusive

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 5

Awards & highlights

Study Summary

This trial is studying the effects of a supplement called acetyl-L-carnitine on teens with alcohol use disorder who also have mild depression.

Who is the study for?

Adolescents aged 14-20 with alcohol use disorder and mild depressive symptoms can join this trial. They must be able to take oral medication, follow the study schedule, and if female of childbearing potential, agree to reliable birth control. Exclusions include liver disease, positive drug screen for certain substances, recent addiction treatment or medical detoxification need.Check my eligibility

What is being tested?

The trial is testing whether acetyl-L-carnitine (ALCAR), taken daily at a dose of 3 grams for four weeks, affects cravings for alcohol in young people with alcohol use disorder compared to a placebo. It also looks at mood, sleep quality, and safety of ALCAR.See study design

What are the potential side effects?

Possible side effects from acetyl-L-carnitine may include stomach upset or pain, nausea/vomiting, restlessness and a 'fishy' odor of the urine/breath/sweat. Rarely it might cause seizures in those with seizure disorders.

Eligibility Criteria

Inclusion Criteria

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

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I can take pills and will follow the medication schedule.

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I am between 14 and 20 years old.

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I drink alcohol at least 2 days a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 5 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Alcohol Craving (derived from the Alcohol Urge Questionnaire; 0 to 20; higher scores = greater urge to drink)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Acetyl-L-CarnitineExperimental Treatment1 Intervention

Acetyl-L-carnitine is a nutritional supplement and emerging research shows it has neuroprotective properties and may help treat alcohol use disorder and depression, 3 g daily for 6 weeks

Group II: PlaceboPlacebo Group1 Intervention

Daily for 6 weeks

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Acetyl-l-carnitine

2015

Completed Phase 3

~20

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

Acetyl-L-carnitine (ALCAR) is being studied for its potential benefits in treating alcoholism due to its role in enhancing mitochondrial function and energy metabolism. ALCAR helps in the transport of fatty acids into the mitochondria, where they are oxidized to produce energy, which can be particularly beneficial in repairing the cellular damage caused by chronic alcohol consumption. This mechanism is crucial for alcoholism patients as it may help alleviate some of the neurotoxic effects of alcohol and improve overall brain function. Other common treatments for alcoholism include naltrexone, which works by blocking opioid receptors to reduce the rewarding effects of alcohol, and disulfiram, which inhibits the enzyme acetaldehyde dehydrogenase, causing unpleasant reactions when alcohol is consumed. These treatments aim to reduce cravings and prevent relapse, addressing both the psychological and physiological aspects of alcohol dependence.

Protective effect of treatment with thiamine or benfotiamine on liver oxidative damage in rat model of acute ethanol intoxication.Effect of acetyl-L-carnitine on ethanol consumption and alcohol abstinence syndrome in rats.