Medication Development in Alcoholism: Investigating PPAR Agonists
Condition: Alcoholism
MeSH terms: Alcoholism
Intervention: Sugar Pill; TRICOR (fenofibrate)
Intervention description: 145 mg/day, oral pill, 9 days; 145 mg/day, oral pill, 9 days
Intervention MeSH terms: Fenofibrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Alcohol; Relapse

Summary:

      The primary hypotheses under test are that alcohol dependent subjects treated with
      fenofibrate will report decreased craving for alcohol following cue-exposure in the
      laboratory and report less drinking post treatment relative to placebo.
    

Eligibility criteria:

        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