Using L-Carnitine to Improve Alcohol Treatment

L-carnitine Supplementation for Co-occurring Depression and Alcohol Use Disorder in Youth: An Open Trial Pilot Study

This study is testing if taking L-carnitine can help young adults aged 18-25 with alcohol use disorder and mild depression feel less cravings for alcohol.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 25 Years
• Sex: All
• Sponsor: Brown University (Academic / other)
• Locations: 1 site (Providence, Rhode Island)
• Trial ID: NCT05355311 on ClinicalTrials.gov

What this trial studies

This study evaluates the effects of L-carnitine, administered at a dose of 2.97g daily, on alcohol cravings in young adults aged 18-25 with alcohol use disorder (AUD) and mild depressive symptoms. Participants will undergo a human laboratory paradigm after four weeks of daily dosing to assess changes in alcohol craving, use, mood, and other related factors. The study aims to determine the safety and tolerability of L-carnitine while exploring its potential to enhance treatment outcomes for AUD.

Who should consider this trial

Good fit: Ideal candidates for this study are young adults aged 18-25 who meet the criteria for alcohol use disorder and report mild depressive symptoms.

Not a fit: Patients who do not meet the age requirement or do not have alcohol use disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a novel adjunct treatment for young adults struggling with alcohol use disorder, potentially reducing cravings and improving overall treatment outcomes.

How similar studies have performed: While the specific use of L-carnitine for alcohol use disorder is novel, similar studies exploring adjunct treatments for AUD have shown promise.

Eligibility criteria

Inclusion Criteria:

1. Be 18 to 25 years old, inclusive
2. Self-report consuming alcohol ≥ 2 days/week on average in the past 28 days
3. Meets the DSM-5 criteria for alcohol use disorder (AUD)
4. Be interested in reducing alcohol use
5. Report at least mild depressive symptoms, as indicated by a score ≥ 14 on the Beck Depression Inventory II.
6. Be able to verbalize an understanding of the consent/assent form, able to provide written informed consent/assent, verbalize willingness to complete study procedures, able to understand written and oral instructions in English and able to complete the questionnaires required by the protocol.
7. Have parent permission, if younger than 18 years
8. Be able to take oral medication and be willing to adhere to the medication regimen
9. Complete all assessments required at screening and baseline.
10. 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.
11. Agree to the schedule of visits, verbally acknowledge ability to attend each scheduled visit, participate in phone visits and report no scheduled events or a job that may substantially interfere with study participation.
12. Not anticipate any significant problems with transportation arrangements or available time to travel to the study site over the next 2 months.
13. Agree (if the subject's sex is female and of childbearing potential) to use at least one reliable method of birth control, unless subject is surgically sterile, partner is surgically sterile, or subject is postmenopausal. Examples of reliable methods include (but may not be limited to):

    1. oral contraceptives
    2. contraceptive sponge
    3. contraceptive skin patch
    4. double barrier diaphragm (diaphragm/spermicidal or condom/spermicidal)
    5. intrauterine contraceptive system
    6. levonorgestrel implant
    7. medroxyprogesterone acetate contraceptive injection
    8. complete abstinence from sexual intercourse
    9. hormonal vaginal contraceptive ring

Exclusion Criteria:

1. Be currently receiving alcohol use disorder treatment
2. Have significant alcohol withdrawal symptoms (score \> 10) on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-AR)
3. Have a coexisting moderate to severe substance use disorder other than cannabis and nicotine, as defined by DSM-5 criteria
4. Have a urine toxicology screen positive performed during screening or baseline for any of the following substances:

   1. benzodiazepines
   2. cocaine
   3. opiates
   4. amphetamines
   5. buprenorphine
   6. methadone
   7. barbiturates
   8. oxycodone
   9. 3, 4-methylenedioxy-methamphetamine (MDMA, also known as ecstasy)
   10. methamphetamines
5. Have been treated with a pharmacotherapy for alcohol use disorder or a carbonic anhydrase inhibitor within 30 days prior to randomization
6. Compelled to alcohol treatment by the juvenile justice system or has probation or parole requirements that might interfere with study participation
7. Have a history of liver disease or have clinically significant abnormal laboratory values, including elevation of liver enzymes (AST, ALT) 5-fold above the upper limit of normal (ULN), or bilirubin greater than 2 times the upper limit of normal.
8. History of renal impairment or renal stones, heart problems or defects, abnormal blood pressure, progressive neurodegenerative disorder, or clinically significant neurological disorders
9. Clinically significant physical abnormalities per physical exam, hematological assessment, bilirubin concentration, or urinalysis
10. Pregnancy, nursing, or refusal to use reliable birth control, if female of childbearing potential
11. Stable dose of any prescribed psychotropic medication (i.e., no dose changes in the 2 months prior to randomization)
12. Current or lifetime diagnosis of psychotic disorders or current bipolar disorder
13. Current suicidality risk
14. Known sensitivity to acetyl-l-carnitine
15. Be a subject who in the opinion of the investigator could not be safely withdrawn from alcohol without medical detoxification
16. Have a serious or unstable medical illness or any potentially life-threatening or progressive medical condition other than addiction that may compromise subject safety or study conduct
17. Have abnormal calculated creatinine clearance defined as \< 80 mL/min
18. Have data suggesting cirrhosis of the liver (albumin \< 3.2 g/dL, or ascites by physical exam)

Where this trial is running

Providence, Rhode Island

• Brown University — Providence, Rhode Island, United States (Recruiting)

Study contacts

• Principal investigator: Robert Miranda, PhD — Brown University
• Study coordinator: Robert Miranda, PhD

Conditions Alcohol Use Disorder