Medication Development in Alcoholism: Investigating PPAR Agonists
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sugar Pill
TRICOR (fenofibrate)
Sponsored by
About this trial
This is an interventional other trial for Alcoholism focused on measuring Alcohol, Relapse
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
Sites / Locations
- Susan Quello
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
TRICOR (fenofibrate)
Sugar Pill
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02158273
First Posted
May 28, 2014
Last Updated
May 2, 2017
Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
1. Study Identification
Unique Protocol Identification Number
NCT02158273
Brief Title
Medication Development in Alcoholism: Investigating PPAR Agonists
Official Title
Medication Development in Alcoholism: Investigating PPAR Agonists
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Scripps Research Institute
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
Alcohol, Relapse
7. Study Design
Primary Purpose
Other
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TRICOR (fenofibrate)
Arm Type
Active Comparator
Arm Title
Sugar Pill
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Sugar Pill
Intervention Description
145 mg/day, oral pill, 9 days
Intervention Type
Drug
Intervention Name(s)
TRICOR (fenofibrate)
Other Intervention Name(s)
Fenofibrate, Fenoglide, Trilipix, Lipofen
Intervention Description
145 mg/day, oral pill, 9 days
Primary Outcome Measure Information:
Title
Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period
Description
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.
Time Frame
1 week following administration of fenofibrate
Secondary Outcome Measure Information:
Title
Change From Baseline in Standard Drinks Per Week at 1 Week
Description
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.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Barbara J. Mason, Ph.D.
Organizational Affiliation
The Scripps Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Susan Quello
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Medication Development in Alcoholism: Investigating PPAR Agonists
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