COMPLETED

Enhancing the Effects of Alcohol Treatment With L-Carnitine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 paradigm after 4 weeks of daily dosing among participants ages 18-25 with alcohol use disorder (AUD) as confirmed by the Diagnostic and Statistical Manual of Mental Disorders - Fifth Edition (DSM-5™) and who report at least mild depressive symptoms on the Beck Depression Inventory-II. Secondary objectives include evaluation of L-carnitine (2.97g/day) on alcohol craving and use, subjective effects of alcohol consumption, mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability.

Official Title

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

Quick Facts

Study Start:2024-09-27

Study Completion:2025-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT05355311

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 25 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	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)

Inclusion Criteria

Exclusion 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

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)

Contacts and Locations

Principal Investigator

Robert Miranda, PhD

PRINCIPAL_INVESTIGATOR

Brown University

Study Locations (Sites)

Brown University

Providence, Rhode Island, 02903

United States

Collaborators and Investigators

Sponsor: Brown University

Robert Miranda, PhD, PRINCIPAL_INVESTIGATOR, Brown University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-27

Study Completion Date2025-05-31

Study Record Updates

Study Start Date2024-09-27

Study Completion Date2025-05-31

Terms related to this study

Additional Relevant MeSH Terms

Alcohol Use Disorder