Enhancing the Effects of Adolescent Alcohol Treatment With Acetyl-L-Carnitine

March 21, 2023 updated by: Brown University

Acetyl-L-carnitine Supplementation for Co-occurring Depression and Alcohol Use Disorder in Adolescents: A Randomized Placebo-Controlled Pilot Study

The primary objective of this study is to evaluate the effects of acetyl-L-carnitine (ALCAR), 3 g daily, and matched placebo on alcohol cue-elicited alcohol craving during a human laboratory paradigm after 4 weeks of daily dosing among participants ages 14-20 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 ALCAR (3g/day) and matched placebo on alcohol craving and use, subjective effects of alcohol consumption, mood, sleep, alcohol use negative consequences, study retention, and safety and tolerability.

Study Overview

Status

Not yet recruiting

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Brown University Center for Alcohol and Addiction Studies

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.

Eligibility Criteria

Ages Eligible for Study

14 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Be 14 to 20 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acetyl-L-Carnitine
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
Acetyl-L-carnitine is an endogenous precursor of acetylcholine and metabolic intermediate that facilitates the transport of acetyl groups across the mitochondrial membrane and shows promise for treating alcohol use disorder and depression.
Other Names:
  • L-carnitine
Placebo Comparator: Placebo
Daily for 6 weeks
Matching placebo (sugar pill)
Other Names:
  • Sugar Pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alcohol Craving (derived from the Alcohol Urge Questionnaire; 0 to 20; higher scores = greater urge to drink)
Time Frame: Week 5
Strength of self-reported alcohol craving
Week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Robert Miranda, PhD, 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 Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

August 1, 2024

Study Completion (Anticipated)

August 1, 2024

Study Registration Dates

First Submitted

April 21, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

May 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

With participant consent, data will be uploaded into appropriate NIH repository as required.

IPD Sharing Time Frame

Within 12 months of publication

IPD Sharing Access Criteria

Any investigator who requests access in writing will be provided with the requested information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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