This trial has been completed.

Condition alcoholism
Treatments sugar pill, tricor (fenofibrate)
Phase phase 2
Sponsor The Scripps Research Institute
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date May 2014
End date April 2016
Trial size 50 participants
Trial identifier NCT02158273, AA012602-14A1, R01AA012602


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
(Active Comparator)
tricor (fenofibrate) Fenofibrate
145 mg/day, oral pill, 9 days
(Placebo Comparator)
sugar pill
145 mg/day, oral pill, 9 days

Primary Outcomes

Craving to Drink
time frame: 9 days

Secondary Outcomes

Drinking Measured by Timeline Follow Back Interview
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Medication Development in Alcoholism: Investigating PPAR Agonists
Principal investigator Barbara J. Mason, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by The Scripps Research Institute.