Medication Development in Alcoholism: Investigating PPAR Agonists

Inclusion Criteria:

- Male or female volunteers, 18-65 years of age

- Meets DSM-V criteria for Alcohol Use Disorder ≥ moderate severity and DSM-IV criteria
for current alcohol dependence

- Subjects will not be seeking treatment because the medication studies are not
treatment trials

- Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to
the human lab session

- Negative BAC and a CIWA score of < 9 at screening and time of lab session to
eliminate acute alcohol or withdrawal effects on dependent measures

- In acceptable health in the judgment of the study physician, on the basis of
interview, medical history, physical exam, ECG, urine test and lab tests

- Females with childbearing potential must have a negative serum pregnancy test on the
screening visit with a negative urine pregnancy test at randomization and agree to
use an effective method of birth control for the study duration and two weeks
thereafter.

- Subjects must be able to complete and understand questionnaires and study procedures
in English and sign an informed consent

- Willingness to comply with the provisions of the protocol and take daily oral
medication

Exclusion Criteria:

- Subjects with a medical condition that contraindicates the administration of
fenofibrate or that will increase potential risk as determined by the Study
Physician.

- GGT more than 3 times the upper limit of normal

- Female subjects with childbearing potential who are pregnant, nursing, or refuse to
use an effective method of birth control for the duration of the study and two weeks
thereafter

- Meets DSM-V criteria for a major Axis I disorder including mood or anxiety disorders
or substance use disorders (e.g., cocaine, amphetamines, heroin, PCP) other than
alcohol or nicotine

- Has a positive UDS at screening or Visit 3 (laboratory session)

- Treatment within the month prior to screening with an investigational drug, vaccine
or drugs that may influence study outcomes, or drugs that may pose a safety risk as
determined by the Study Physician.

- History of hypersensitivity to the study drugs or the ingredients