Acetyl-L-Carnitine for Alcoholism

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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing whether a supplement called acetyl-L-carnitine (ALCAR) can help young people aged 14-20 with alcohol use disorder and mild depression reduce their cravings for alcohol. The study will also look at other effects like mood, sleep, and safety.

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.

How does the drug Acetyl-L-Carnitine differ from other treatments for alcoholism?

Acetyl-L-Carnitine is unique because it may help reduce alcohol cravings and prevent relapse by addressing anhedonia (inability to feel pleasure) in alcohol-dependent individuals, which is not a common focus of other treatments. Additionally, it has shown potential in improving cognitive deficits and reducing withdrawal symptoms, offering a broader range of benefits compared to standard treatments. ^{1 2 3 4 5}

Research Team

Robert Miranda, PhD

Principal Investigator

Brown University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Acetyl-L-carnitine for alcohol craving and relapse prevention in anhedonic alcoholics: a randomized, double-blind, placebo-controlled pilot trial. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Acetyl-l-Carnitine in the treatment of anhedonia, melancholic and negative symptoms in alcohol dependent subjects. [2013]

3. England pubmed.ncbi.nlm.nih.gov

Effect of L-carnitine on ethanol and acetate plasma levels after oral administration of ethanol in humans. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Role of acetyl-L-carnitine in the treatment of cognitive deficit in chronic alcoholism. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of acetyl-L-carnitine on ethanol consumption and alcohol abstinence syndrome in rats. [2013]