Medication Development in Alcoholism: Investigating PPAR Agonists

The Scripps Research Institute

Status and phase

Completed

Phase 2

Conditions

Alcoholism

Treatments

Drug: Sugar Pill

Drug: TRICOR (fenofibrate)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02158273

AA012602-14A1

R01AA012602 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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