Skip to main content
OpenTrials
Completed

NCT Number: NCT02158273

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcoholism Alcohol-Related Disorders Chemically-Induced Disorders Disease Attributes Mental Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Susan Quello

La Jolla, California, 92037, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sugar pill

Drug

145 mg/day, oral pill, 9 days

TRICOR (fenofibrate)

Drug

145 mg/day, oral pill, 9 days

Other names: Fenofibrate, Fenoglide, Trilipix, Lipofen

Primary outcomes

  1. Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period

    Time frame: 1 week following administration of fenofibrate

    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.

Secondary outcomes

  1. Change From Baseline in Standard Drinks Per Week at 1 Week

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Scripps Research Institute

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 6, 2014
Registry last updated
Jun 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.