Enhancing the Effects of Alcohol Treatment With L-Carnitine

NCT05355311 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 2101002877R21AA029033-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• Alcohol Craving (derived from the Alcohol Urge Questionnaire; 0 to 20; higher scores = greater urge to drink)

  Strength of self-reported alcohol craving

  Week 5

Study Arms (1)

L-Carnitine

EXPERIMENTAL

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

Drug: L-carnitine

Interventions

L-carnitine DRUG

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.

L-Carnitine

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be 18 to 25 years old, inclusive
• Self-report consuming alcohol ≥ 2 days/week on average in the past 28 days
• Meets the DSM-5 criteria for alcohol use disorder (AUD)
• Be interested in reducing alcohol use
• Report at least mild depressive symptoms, as indicated by a score ≥ 14 on the Beck Depression Inventory II.
• 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.
• Have parent permission, if younger than 18 years
• Be able to take oral medication and be willing to adhere to the medication regimen
• Complete all assessments required at screening and baseline.
• 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.
• 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.
• Not anticipate any significant problems with transportation arrangements or available time to travel to the study site over the next 2 months.
• 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):
• oral contraceptives
• contraceptive sponge

You may not qualify if:

• Be currently receiving alcohol use disorder treatment
• Have significant alcohol withdrawal symptoms (score \> 10) on the Clinical Institute Withdrawal Assessment for Alcohol-Revised (CIWA-AR)
• Have a coexisting moderate to severe substance use disorder other than cannabis and nicotine, as defined by DSM-5 criteria
• Have a urine toxicology screen positive performed during screening or baseline for any of the following substances:
• benzodiazepines
• cocaine
• opiates
• amphetamines
• buprenorphine
• methadone
• barbiturates
• oxycodone
• , 4-methylenedioxy-methamphetamine (MDMA, also known as ecstasy)
• methamphetamines
• Have been treated with a pharmacotherapy for alcohol use disorder or a carbonic anhydrase inhibitor within 30 days prior to randomization

Sponsors & Collaborators

• Brown University: lead
• Rhode Island Hospital: collaborator
• Colorado State University: collaborator
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Officials

• Robert Miranda, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is an open-label study designed to assess the effects of L-carnitine supplementation on responses to in vivo alcohol cue exposure in the human laboratory setting.

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: May 2, 2022
• Study Start: September 27, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Within 12 months of publication
• Access Criteria: Any investigator who requests access in writing will be provided with the requested information.

Locations

US (1)