Medication Development in Alcoholism: Investigating PPAR Agonists

NCT ID: NCT02158273

Last Updated: 2017-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2016-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

TRICOR (fenofibrate)

Group Type: ACTIVE_COMPARATOR

TRICOR (fenofibrate)

Intervention Type: DRUG

145 mg/day, oral pill, 9 days

Sugar Pill

Group Type: PLACEBO_COMPARATOR

Sugar Pill

Intervention Type: DRUG

145 mg/day, oral pill, 9 days

Interventions

Sugar Pill

145 mg/day, oral pill, 9 days

Intervention Type: DRUG

TRICOR (fenofibrate)

145 mg/day, oral pill, 9 days

Intervention Type: DRUG

Other Intervention Names

Fenofibrate; Fenoglide; Trilipix; Lipofen

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

The Scripps Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Barbara J. Mason

PI

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Barbara J. Mason, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Scripps Research Institute

Locations

Susan Quello

La Jolla, California, United States

Countries

United States

Other Identifiers

R01AA012602

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AA012602-14A1

Identifier Type: -

Identifier Source: org_study_id