Clinical trial for Alcohol Drinking
Official title Ketone Ester Intervention in Alcohol Use Disorder
ClinicalTrials.gov ID: NCT04616781
What this study is testing
- What it's testing
- The study wants to find out if a single dose of a ketone ester drink can lower brain reactions to alcohol cues, reduce craving, and change how much alcohol people drink. It also checks if the drink raises ketone levels in the brain.
- Who it's for
- Adults who regularly drink alcohol and have Alcohol Use Disorder but are not currently seeking treatment
- What's involved
- Participants will visit the clinic twice, once to drink the ketone ester and once to drink a placebo drink that tastes the same. After each drink they will have brain scans (fMRI and proton spectroscopy) and then complete a task that measures how much alcohol they would choose to drink.
- Time commitment
- The study lasts about two days of visits, with each visit including a drink, brain scans, and a drinking task.
- 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 21 to 65. Healthy volunteers may be eligible.
You may be able to join if
- Age 21 years to 65 years old.
- Willingness to provide signed, informed consent and commit to completing the procedures in the study
- Meets DSM-5 criteria for AUD
- Average weekly ethanol consumption of at least 15 standard drinks over the past month prior to consent (self-report)
- Participants not seeking treatment for their AUD (self-report)
You likely can't join if
- Unwilling or unable to refrain from use, within 24 hours of MRI procedures, psychoactive medications or medication that may affect study results...
- Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders, or substance use disorders that are...
- Urine drug screen positive for recent use of opioids, cocaine, or amphetamines on study visits (may be repeated once and if the result is negative on...
- A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory...
- Currently suffering from or with a history of stroke and/or stroke related spasticity.
- History of seizures.
See the full eligibility criteria
- Age 21 years to 65 years old.
- Willingness to provide signed, informed consent and commit to completing the procedures in the study
- Meets DSM-5 criteria for AUD
- Average weekly ethanol consumption of at least 15 standard drinks over the past month prior to consent (self-report)
- Participants not seeking treatment for their AUD (self-report)
- Alcohol specified as the preferred drug (self-report).
- Women of child-bearing potential (i.e., who have not had a hysterectomy, bilateral oophorectomy, tubal ligation or is less than two years postmenopausal): must be non-lactating and practicing a reliable method of birth...
- Unwilling or unable to refrain from use, within 24 hours of MRI procedures, psychoactive medications or medication that may affect study results (e.g., analgesics containing narcotics, antibiotics, anti-inflammatory...
- Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol and nicotine use disorders, or substance use disorders that are mild/moderate) that required hospitalization, or that required daily...
- Urine drug screen positive for recent use of opioids, cocaine, or amphetamines on study visits (may be repeated once and if the result is negative on repeat it is not exclusionary).
- A current, clinically significant physical disease or abnormality on the basis of medical history, physical examination, or routine laboratory evaluation that can impact brain function, the use of a ketone ester or the...
- Currently suffering from or with a history of stroke and/or stroke related spasticity.
- History of seizures.
- HIV positive, as the human immunodeficiency virus affects the brain.
- Head trauma with loss of consciousness for more than 30 minutes or associated with skull fracture or inter-cranial bleeding or abnormal MRI. (self-report, medical history).
- Presence of ferromagnetic objects in the body that are contraindicated for MRI of the head, fear of enclosed spaces, or other standard contraindication to MRI (self-report checklist).
- Claustrophobia or other medical condition preventing subject from lying comfortably flat on his/her back for up to 2 hours in the MRI scanner (self-report).
- BMI \> 35, body girth greater than 52 inches and a head girth greater than 25 inches (imaging data acquisition is impaired with high-weight individuals).
- Vision problems that cannot be corrected with glasses.
- Judged by the principal investigator or his designee to be an unsuitable candidate for study participation.
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, 21 years to 65 years. Healthy volunteers may be eligible. 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.