Ketone Ester Intervention in Alcohol Use Disorder

Launched by UNIVERSITY OF PENNSYLVANIA · Oct 29, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating whether a special drink called a ketone ester can help people with Alcohol Use Disorder (AUD) by affecting how their brain reacts to alcohol and cravings. The researchers want to see if drinking the ketone ester can change brain activity and reduce the urge to drink alcohol. Participants will take part in two separate sessions where they will drink either the ketone ester or a similar-looking drink that doesn’t contain it. After each drink, they will undergo brain scans and complete tasks related to alcohol consumption.

To join this study, participants need to be between 21 and 65 years old, have a history of drinking alcohol frequently, and not be seeking treatment for their alcohol use. They should also be able to commit to the study procedures and sign a consent form. During the trial, participants will have two visits, where they will drink one of the two beverages and then be scanned while their brain activity is monitored. It’s essential for participants to not take certain medications or have specific health conditions, as these could affect the results. Overall, this trial aims to explore a new approach to help people manage their alcohol cravings and improve brain function related to drinking.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 21 years to 65 years old.
• • 2. Willingness to provide signed, informed consent and commit to completing the procedures in the study
• • 3. Meets DSM-5 criteria for AUD
• • 4. Average weekly ethanol consumption of at least 15 standard drinks over the past month prior to consent (self-report)
• • 5. Participants not seeking treatment for their AUD (self-report)
• • 6. Alcohol specified as the preferred drug (self-report).
• • 7. 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 control, and have a negative urine pregnancy test prior to the initiation of the study and MRI procedures. Examples of medically acceptable methods for this protocol include: the birth control pill, intrauterine device (no copper IUD), injection of Depo-Provera, Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such as condoms and diaphragm/spermicide), male partner sterilization, abstinence (and agreement to continue abstinence or to use an acceptable method of contraception, as listed above, should sexual activity commence), and tubal ligation.
• Exclusion Criteria:
• • 1. 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 drugs).
• • 2. 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 medications for over 4 weeks in the past year (i.e., antidepressants; anticholinergics; antipsychotics; anxiolytics; lithium; psychotropic drugs not otherwise specified (nos) including herbal products (no drugs with psychomotor effects or with anxiolytics, stimulant, antipsychotic, or sedative properties); sedatives/hypnotics).
• • 3. 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).
• • 4. 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 use of alcohol (e.g., epilepsy, diabetes, liver disease, kidney disease, kidney stones, chronic metabolic acidosis or a cardiomyopathy as determined by history and clinical exam).
• • 5. Currently suffering from or with a history of stroke and/or stroke related spasticity.
• • 6. History of seizures.
• • 7. HIV positive, as the human immunodeficiency virus affects the brain.
• • 8. 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).
• • 9. 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).
• • 10. 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).
• • 11. 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).
• • 12. Vision problems that cannot be corrected with glasses.
• • 13. Judged by the principal investigator or his designee to be an unsuitable candidate for study participation.