Alcohol Use DisorderPhase 1NCT05355311
Enhancing the Effects of Alcohol Treatment With L-Carnitine
A Phase 1 study testing L-carnitine in people with Alcohol Use Disorder, run by Brown University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Alcohol Use Disorder
- What is being tested?
- L-carnitine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to 31 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
- contraceptive skin patch
- double barrier diaphragm (diaphragm/spermicidal or condom/spermicidal)
- intrauterine contraceptive system
- levonorgestrel implant
- medroxyprogesterone acetate contraceptive injection
- complete abstinence from sexual intercourse
- hormonal vaginal contraceptive ring
Who cannot join
- 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
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- opiates
- amphetamines
- buprenorphine
- methadone
- barbiturates
- oxycodone
- 3, 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
- Compelled to alcohol treatment by the juvenile justice system or has probation or parole requirements that might interfere with study participation
- 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.
- History of renal impairment or renal stones, heart problems or defects, abnormal blood pressure, progressive neurodegenerative disorder, or clinically significant neurological disorders
- Clinically significant physical abnormalities per physical exam, hematological assessment, bilirubin concentration, or urinalysis
- Pregnancy, nursing, or refusal to use reliable birth control, if female of childbearing potential
- Stable dose of any prescribed psychotropic medication (i.e., no dose changes in the 2 months prior to randomization)
- Current or lifetime diagnosis of psychotic disorders or current bipolar disorder
- Current suicidality risk
- Known sensitivity to acetyl-l-carnitine
- Be a subject who in the opinion of the investigator could not be safely withdrawn from alcohol without medical detoxification
- 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
- Have abnormal calculated creatinine clearance defined as < 80 mL/min
- Have data suggesting cirrhosis of the liver (albumin < 3.2 g/dL, or ascites by physical exam)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: L-carnitine Supplementation for Co-occurring Depression and Alcohol Use Disorder in Youth: An Open Trial Pilot Study
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
- Being tested
- L-carnitine
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-carnitineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: L-carnitine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alcohol Craving (derived from the Alcohol Urge Questionnaire; 0 to 20; higher scores = greater urge to drink)
Strength of self-reported alcohol craving
Measured: Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start27 Sep 2024
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- Rhode Island Hospital, Colorado State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor
- Investigators
- Robert Miranda, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355311
- Sponsor's protocol ID
- 2101002877
- Other IDs
- R21AA029033-01A1
- Status last verified
- Jun 2025
- First submitted
- 21 Apr 2022
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: With participant consent, data will be uploaded into appropriate NIH repository as required.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-carnitine Supplementation for Co-occurring Depression and Alcohol Use Disorder in Youth: An Open Trial Pilot Study
- ClinicalTrials.gov ID
- NCT05355311
- Acronym / sponsor ID
- 2101002877
- Conditions
- Alcohol Use Disorder
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- Rhode Island Hospital, Colorado State University, National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| L-Carnitine | Experimental | Drug: L-carnitineL-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 may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (28 listed)
- 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:
- Have been treated with a pharmacotherapy for alcohol use disorder or a carbonic anhydrase inhibitor within 30 days prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-carnitineL-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. | Drug | L-Carnitine |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: Yes. With participant consent, data will be uploaded into appropriate NIH repository as required.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Miranda, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing L-carnitine in people with Alcohol Use Disorder, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alcohol Craving (derived from the Alcohol Urge Questionnaire; 0 to 20; higher scores = greater urge to drink) (time frame: Week 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.