Medication Development in Alcoholism: Investigating PPAR Agonists

NCT02158273 | Completed Phase 2 Results

• 2 other identifiers: AA012602-14A1R01AA012602
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcoholism

Keywords

Alcohol; Relapse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  1 week

Study Arms (2)

TRICOR (fenofibrate)

ACTIVE COMPARATOR

Drug: TRICOR (fenofibrate)

Sugar Pill

PLACEBO COMPARATOR

Drug: Sugar Pill

Interventions

Sugar Pill DRUG

145 mg/day, oral pill, 9 days

Sugar Pill

TRICOR (fenofibrate) DRUG

145 mg/day, oral pill, 9 days

Also known as: Fenofibrate, Fenoglide, Trilipix, Lipofen

TRICOR (fenofibrate)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Scripps Research Institute: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Susan Quello

La Jolla, California, 92037, United States

Location

MeSH Terms

Conditions

Alcoholism; Recurrence

Interventions

Sugars; Fenofibrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbohydrates; Fibric Acids; Isobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Phenyl Ethers; Ethers; Benzophenones; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenols; Ketones

Results Point of Contact

• Title: Dr. Barbara Mason
• Organization: The Scripps Research Institute

mason@scripps.edu

(858) 784-7324

Study Officials

• Barbara J. Mason, Ph.D.

  The Scripps Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: May 28, 2014
• First Posted: June 6, 2014
• Study Start: May 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 2, 2017
• Results First Posted: June 2, 2017

Record last verified: 2017-05

Locations

US (1)