- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05355311
Enhancing the Effects of Adolescent Alcohol Treatment With Acetyl-L-Carnitine
Acetyl-L-carnitine Supplementation for Co-occurring Depression and Alcohol Use Disorder in Adolescents: A Randomized Placebo-Controlled Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Brianna Parlette, ScM
- Phone Number: 401-863-6687
- Email: Brianna_Parlette@brown.edu
Study Contact Backup
- Name: Robert Miranda, PhD
- Phone Number: 401-863-6658
- Email: Robert_Miranda_Jr@brown.edu
Study Locations
-
-
Rhode Island
-
Providence, Rhode Island, United States, 02903
- Brown University Center for Alcohol and Addiction Studies
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Be 14 to 20 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
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
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:
|
Placebo Comparator: Placebo
Daily for 6 weeks
|
Matching placebo (sugar pill)
Other Names:
|
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Robert Miranda, PhD, Brown University
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2101002877
- R21AA029033-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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