Medication Development in Alcoholism: Investigating PPAR Agonists

Alcoholism Clinical Trial

Official title:

Medication Development in Alcoholism: Investigating PPAR Agonists

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02158273
• Other study ID #: AA012602-14A1
• Secondary ID: R01AA012602
• Status: Completed
• Phase: Phase 2
• First received: May 28, 2014
• Last updated: December 7, 2016
• Start date: May 2014
• Est. completion date: April 2016

Study information

• Verified date: December 2016
• Source: The Scripps Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• Sugar Pill
145 mg/day, oral pill, 9 days
• TRICOR (fenofibrate)
145 mg/day, oral pill, 9 days

Locations

Country	Name	City	State
United States	Susan Quello	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
The Scripps Research Institute	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Craving to Drink	Craving scores on the Visual Analog Scale	9 days	No
Secondary	Drinking Measured by Timeline Follow Back Interview		4 weeks	No