Medication Development in Alcoholism: Investigating PPAR Agonists

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.

Study Overview

• Status: Completed
• Conditions: Alcoholism
• Intervention / Treatment: Drug: TRICOR (fenofibrate); Drug: Sugar Pill

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • Susan Quello

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Sugar Pill	Drug: Sugar Pill; 145 mg/day, oral pill, 9 days
Active Comparator: TRICOR (fenofibrate)	Drug: TRICOR (fenofibrate); 145 mg/day, oral pill, 9 days; Other Names: Trilipix; Fenofibrate; Fenoglide; Lipofen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period	The four Visual Analog Scale (VAS) questions assess domains of alcohol craving: the intention to drink, loss of control, relief craving, and urge intensity. Each VAS scale item score ranges from 1-20 where a one indicates no craving and 20 indicates severe craving; thus, a higher score indicates a worse outcome. Total is a summation of the four VAS item scores (i.e. Intent, Impulse, Relief, Strength) and ranges in value from 4-80 with higher scores indicative of a worse outcome.	1 week following administration of fenofibrate

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Standard Drinks Per Week at 1 Week	Standard drinks are equivalent to 14 grams of pure alcohol and number of drinks are assessed with Timeline Follow-Back (TLFB) methods. Change = (Week 1 - Baseline). More negative values indicate less use of alcohol.	1 week

Collaborators and Investigators

• Sponsor: The Scripps Research Institute
• Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: May 28, 2014
• First Submitted That Met QC Criteria: June 4, 2014
• First Posted (Estimate): June 6, 2014

Study Record Updates

• Last Update Posted (Actual): June 2, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: Alcohol; Relapse
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: AA012602-14A1; R01AA012602 (U.S. NIH Grant/Contract)