Phase
Condition
Addictions
Alcohol Dependence
Substance Abuse
Treatment
Isocaloric dextrose placebo
Alcohol drinks
Ketone Ester "(R)-3-hydroxybutyl (R)-3-hydroxybutyrate"
Clinical Study ID
Ages 21-65 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age 21 years to 65 years old.
Willingness to provide signed, informed consent and commit to completing theprocedures in the study
Meets DSM-5 criteria for AUD
Average weekly ethanol consumption of at least 15 standard drinks over the pastmonth 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, bilateraloophorectomy, tubal ligation or is less than two years postmenopausal): must benon-lactating and practicing a reliable method of birth control, and have a negativeurine pregnancy test prior to the initiation of the study and MRI procedures.Examples of medically acceptable methods for this protocol include: the birthcontrol pill, intrauterine device (no copper IUD), injection of Depo-Provera,Norplant, contraceptive patch, contraceptive ring, double-barrier methods (such ascondoms and diaphragm/spermicide), male partner sterilization, abstinence (andagreement to continue abstinence or to use an acceptable method of contraception, aslisted above, should sexual activity commence), and tubal ligation.
Exclusion
Exclusion Criteria:
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).
Current DSM-5 diagnosis of a major psychiatric disorder (other than alcohol andnicotine use disorders, or substance use disorders that are mild/moderate) thatrequired hospitalization, or that required daily medications for over 4 weeks in thepast 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, orsedative properties); sedatives/hypnotics).
Urine drug screen positive for recent use of opioids, cocaine, or amphetamines onstudy visits (may be repeated once and if the result is negative on repeat it is notexclusionary).
A current, clinically significant physical disease or abnormality on the basis ofmedical history, physical examination, or routine laboratory evaluation that canimpact brain function, the use of a ketone ester or the use of alcohol (e.g.,epilepsy, diabetes, liver disease, kidney disease, kidney stones, chronic metabolicacidosis or a cardiomyopathy as determined by history and clinical exam).
Currently suffering from or with a history of stroke and/or stroke relatedspasticity.
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 withskull fracture or inter-cranial bleeding or abnormal MRI. (self-report, medicalhistory).
Presence of ferromagnetic objects in the body that are contraindicated for MRI ofthe head, fear of enclosed spaces, or other standard contraindication to MRI (self-report checklist).
Claustrophobia or other medical condition preventing subject from lying comfortablyflat 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 candidatefor study participation.
Study Design
Study Description
Connect with a study center
University of Pennsylvania Center for Studies of Addiction
Philadelphia, Pennsylvania 19104
United StatesActive - Recruiting
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