Medication Development in Alcoholism: Investigating PPAR Agonists

• Status: Completed
• Trial end date: 2016-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Scripps Research Institute
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Fenofibrate

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