Medication Development in Alcoholism: Investigating PPAR Agonists

Phase 2

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
TRICOR (fenofibrate)	TRICOR (fenofibrate)	-
Sugar Pill	Sugar Pill	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period	1 week following administration of fenofibrate	The four Visual Analog Scale (VAS) questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. Each VAS scale item score ranges from 1-20 where a one indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four VAS item scores (i.e. Intent, Impulse, Relief, Strength) and ranges in value from 4-80 with higher scores indicative of a worse outcome.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Standard Drinks Per Week at 1 Week	1 week	Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.