Clinical trial for Alcohol Use Disorder
Official title Effects of Ketone Supplementation on Alcohol Withdrawal and Brain Metabolism in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT06559995
What this study is testing
- What it's testing
- The study wants to find out whether taking a ketone supplement changes withdrawal symptoms and brain metabolism compared with a placebo.
- Who it's for
- Adults who have moderate to severe alcohol use disorder and are entering a 4‑day detox program.
- What's involved
- Participants will be randomly given either a ketone supplement or a placebo during the 4‑day withdrawal period, with regular monitoring of symptoms and possibly brain scans.
- Time commitment
- The trial lasts about four days, with daily visits and assessments while in the detox center.
- Phase 3: a large, late-stage study
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Able to communicate English and provide written informed consent
- Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD
- Minimum 3-year history of heavy drinking (self-report).
- Presence of alcohol withdrawal (DSM-5)
You likely can't join if
- Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures.
- Major medical problems that could impact brain function or the use of a Ketone supplement (e.g., epilepsy or diabetes) as determined by history and...
- Clinically significant laboratory findings that could affect brain function (e.g., HIV+)
- Head trauma with loss of consciousness for more than 30 minutes,
- Pregnant or breast-feeding
- BMI greater than 35
See the full eligibility criteria
- Able to communicate English and provide written informed consent
- Meets current DSM-5 criteria for moderate or severe AUD and seeking treatment for AUD
- Minimum 3-year history of heavy drinking (self-report).
- Presence of alcohol withdrawal (DSM-5)
- Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders) that would interfere with study procedures.
- Major medical problems that could impact brain function or the use of a Ketone supplement (e.g., epilepsy or diabetes) as determined by history and physical exam.
- Clinically significant laboratory findings that could affect brain function (e.g., HIV+)
- Head trauma with loss of consciousness for more than 30 minutes,
- Pregnant or breast-feeding
- BMI greater than 35
- Self-reported claustrophobia
- Contraindications to MRI (e.g., metal in the body that cannot be removed).
- Current, gastrointestinal (GI), liver or other clinically significant physical disease that may interfere with the intake of the Ketone Supplement based on medical history, and evaluation of the Study Physician.
- Current significant withdrawal from other substances, including benzodiazepines, opioids that require medication management for withdrawal and may interfere with study results/withdrawal management plan.
- Judged by the principal investigator, Study Physician, or their designee to be an unsuitable candidate for the study.
The study team makes the final eligibility decision.
Where it is enrolling
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.