Medication Development in Alcoholism: Investigating PPAR Agonists
This trial has been completed.
|Treatments||sugar pill, tricor (fenofibrate)|
|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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator, outcomes assessor)|
Craving to Drink
time frame: 9 days
Drinking Measured by Timeline Follow Back Interview
time frame: 4 weeks
Male or female participants from 18 years up to 65 years old.
- 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
- 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
|Official title||Medication Development in Alcoholism: Investigating PPAR Agonists|
|Principal investigator||Barbara J. Mason, Ph.D.|
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