Acetyl-L-Carnitine for Alcoholism

No longer recruiting at 1 trial location

Overseen By Kristin Rogers, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Brown University

Must not be taking: Benzodiazepines, Cocaine, Opiates, others

Disqualifiers: Substance use disorder, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a nutrient supplement called L-carnitine (also known as Acetyl-L-Carnitine) to determine if it reduces alcohol cravings in people with alcohol use disorder (AUD). Researchers aim to find out if taking L-carnitine daily for four weeks can help participants manage situations that trigger alcohol cravings. A placebo group will serve as a comparison. Suitable candidates for this trial are individuals aged 18 to 25 who drink alcohol at least twice a week, have been diagnosed with AUD, and experience mild depressive symptoms. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this potential new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you have been treated with certain medications for alcohol use disorder or carbonic anhydrase inhibitors within 30 days before starting the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that acetyl-L-carnitine is generally safe to use. One study found that it helped reduce alcohol cravings and delayed the time before someone took their first drink. Importantly, this study reported no serious side effects. Additionally, acetyl-L-carnitine is a common supplement that helps the body convert fat into energy, and it has been used for a long time without major safety concerns. While more research can clarify its effects, current evidence suggests it is well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Acetyl-L-carnitine is unique because it offers a potential new approach to treating alcohol use disorder by leveraging its neuroprotective properties. Unlike standard treatments like naltrexone, acamprosate, or disulfiram, which primarily focus on reducing cravings or causing unpleasant reactions to alcohol, acetyl-L-carnitine could help repair and protect brain cells affected by alcohol use. This unique mechanism of action is what has researchers excited, as it may address some of the underlying neurological impacts of alcoholism, potentially improving both mental health and recovery outcomes.

What evidence suggests that acetyl-L-carnitine might be an effective treatment for alcohol use disorder?

Research has shown that acetyl-L-carnitine (ALC) may help people with alcohol use disorder (AUD) by reducing cravings and the risk of relapse. In one study, participants who took ALC stayed sober longer than those who took a placebo. Another study found that ALC improved mental functions like memory and decision-making, which alcohol abuse can harm. ALC also appears to protect brain cells from alcohol-induced damage. This trial will evaluate ALC as a treatment option, and these findings suggest that ALC could be a promising treatment for people struggling with AUD. ^{2 3 4 5 6}

Who Is on the Research Team?

Robert Miranda, PhD

Principal Investigator

Brown University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Meets the DSM-5 criteria for alcohol use disorder (AUD)

I agree to use birth control if I can have children and am not sterile.

Provide contact information of someone, such as a parent or other family member, who may be able to contact the subject in case of a missed appointment or follow-up assessment

Exclusion Criteria

Be currently receiving alcohol use disorder treatment

I do not have any severe illnesses that could endanger my participation in the study.

Have significant alcohol withdrawal symptoms (score > 10) on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-AR)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive L-carnitine supplementation, 2.97g daily, to evaluate its effects on alcohol craving and use

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Acetyl-l-carnitine
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: L-Carnitine Experimental Treatment 1 Intervention

L-carnitine is a nutritional supplement and emerging research shows it has neuroprotective properties and may help treat alcohol use disorder and depression, 2.97 g daily for 6 weeks

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials

480

Recruited

724,000+

Rhode Island Hospital

Collaborator

Trials

275

Recruited

71,400+

Colorado State University

Collaborator

Trials

138

Recruited

38,200+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8252636/

Carnitine in Alcohol Use Disorders: A Scoping Review - PMC ALC was effective in improving cognition (Tempesta et al., 1990), anhedonia (Martinotti et al., 2011), and reduced incidence of relapse and cravings (Martinotti ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05355311

Enhancing the Effects of Alcohol Treatment With L-Carnitine The primary objective of this study is to evaluate the effects of L-carnitine, 2.97g daily on alcohol cue-elicited alcohol craving during a human laboratory ...

3. academic.oup.com academic.oup.com/alcalc/article/45/5/449/184520

Acetyl-l-Carnitine for Alcohol Craving and Relapse Prevention ... Results: Survival analysis showed that patients treated with ALC remained completely abstinent for longer than those treated with placebo (Z = −2.27; P < 0.05).

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/acer.14568

Carnitine in Alcohol Use Disorders: A Scoping Review Six studies found carnitine to be increased in AUD, of which 5 were conducted in patients with alcoholic cirrhosis.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3022478/

Acetyl-L-carnitine protects neuronal function from alcohol ... Our findings indeed demonstrate therapeutic benefits of ALC in preventing alcohol-induced neurodegeneration, the results of which are reported here.

6. webmd.com webmd.com/vitamins/ai/ingredientmono-834/acetyl-l-carnitine

Acetyl-L-Carnitine – Uses, Side Effects, And More Acetyl-L-carnitine is made from L-carnitine in the body. L-carnitine and acetyl-L-carnitine are used to help the body turn fat into energy.