Alcoholism
Conditions
Keywords
Alcohol, Relapse
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.
Interventions
DRUGSugar Pill
145 mg/day, oral pill, 9 days
DRUGTRICOR (fenofibrate)
145 mg/day, oral pill, 9 days
Sponsors
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The Scripps Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | 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
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Standard Drinks Per Week at 1 Week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fenofibrate TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days | 25 |
| Placebo Matched Placebo | 25 |
| Total | 50 |
Baseline characteristics
| Characteristic | Total | Fenofibrate | Placebo |
|---|---|---|---|
| Age, Continuous | 37.58 years STANDARD_DEVIATION 12.04 | 38.52 years STANDARD_DEVIATION 12.4 | 36.64 years STANDARD_DEVIATION 11.84 |
| Sex: Female, Male Female | 11 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 39 Participants | 21 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 25 | 2 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
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.
Time frame: 1 week following administration of fenofibrate
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fenofibrate | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | Intent | 9.83 units on a scale | Standard Deviation 6.39 |
| Fenofibrate | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | Relief | 6.92 units on a scale | Standard Deviation 6.43 |
| Fenofibrate | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | Impulse | 6.87 units on a scale | Standard Deviation 6.55 |
| Fenofibrate | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | Total | 32.56 units on a scale | Standard Deviation 23.57 |
| Fenofibrate | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | Strength | 8.94 units on a scale | Standard Deviation 5.69 |
| Placebo | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | Total | 37.24 units on a scale | Standard Deviation 21.84 |
| Placebo | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | Strength | 10.37 units on a scale | Standard Deviation 6.01 |
| Placebo | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | Intent | 11.03 units on a scale | Standard Deviation 6.24 |
| Placebo | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | Impulse | 6.98 units on a scale | Standard Deviation 5.62 |
| Placebo | Visual Analog Scale of Craving to Drink at 1 Week Following Administration of Fenofibrate or Placebo During the Double-Blind Period | Relief | 8.86 units on a scale | Standard Deviation 6 |
Secondary
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.
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fenofibrate | Change From Baseline in Standard Drinks Per Week at 1 Week | Drinks/week Baseline | 51.21 drinks/week | Standard Deviation 27.24 |
| Fenofibrate | Change From Baseline in Standard Drinks Per Week at 1 Week | Drinks/week Week 1 | 31.77 drinks/week | Standard Deviation 19.53 |
| Fenofibrate | Change From Baseline in Standard Drinks Per Week at 1 Week | Drinks/week Change | -19.44 drinks/week | Standard Deviation 19.16 |
| Placebo | Change From Baseline in Standard Drinks Per Week at 1 Week | Drinks/week Change | -18.98 drinks/week | Standard Deviation 12.07 |
| Placebo | Change From Baseline in Standard Drinks Per Week at 1 Week | Drinks/week Baseline | 47.22 drinks/week | Standard Deviation 16.55 |
| Placebo | Change From Baseline in Standard Drinks Per Week at 1 Week | Drinks/week Week 1 | 28.24 drinks/week | Standard Deviation 11.44 |