Clinical trial NCT02158273: Medication Development in Alcoholism: Investigating PPAR Agonists
Official title: Medication Development in Alcoholism: Investigating PPAR Agonists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcoholism
Keywords: Alcohol
Relapse
Lead sponsor: The Scripps Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2014-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period
timeFrame: 1 week following administration of fenofibrate
Secondary outcomes:
measure: Change From Baseline in Standard Drinks Per Week at 1 Week
timeFrame: 1 week
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Susan Quello
state: California
Study officials:
affiliation: The Scripps Research Institute
name: Barbara J. Mason, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: