Phase 2
N=50
Medication Development in Alcoholism: Investigating PPAR Agonists
Alcoholism
Bottom Line
View on ClinicalTrials.gov: NCT02158273 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period — 8.94; 10.37; 9.83; 11.03 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Sugar Pill (Drug); TRICOR (fenofibrate) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Scripps Research Institute
- Primary completion
- Apr 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period |
8.94; 10.37; 9.83; 11.03; 6.87; 6.98 | — |
| SECONDARY Change From Baseline in Standard Drinks Per Week at 1 Week |
51.21; 47.22; 31.77; 28.24; -19.44; -18.98 | — |
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
Data sourced from ClinicalTrials.gov (NCT02158273). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.