Enhancing the Effects of Alcohol Treatment With L-Carnitine (NCT05355311) | Clinical Trial Compass
CompletedPhase 1
Enhancing the Effects of Alcohol Treatment With L-Carnitine
United States24 participantsStarted 2024-09-27
Plain-language 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-5â„¢) 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.
Who can participate
Age range18 Years – 25 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. Be currently receiving alcohol use disorder treatment
What they're measuring
1
Alcohol Craving (derived from the Alcohol Urge Questionnaire; 0 to 20; higher scores = greater urge to drink)