Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AA012602 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TRICOR (fenofibrate) | Active Comparator |
| |
| Sugar Pill | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugar Pill | Drug | 145 mg/day, oral pill, 9 days |
| |
| TRICOR (fenofibrate) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Barbara J. Mason, Ph.D. | The Scripps Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Susan Quello | La Jolla | California | 92037 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Fenofibrate | TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days |
| FG001 | Placebo | Matched Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Fenofibrate | TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days |
| BG001 | Placebo | Matched Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week following administration of fenofibrate |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fenofibrate | TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (19.1) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Barbara Mason | The Scripps Research Institute | (858) 784-7324 | mason@scripps.edu |
Not provided
| ID | Term |
|---|---|
| D000437 | Alcoholism |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D000073893 | Sugars |
| D011345 | Fenofibrate |
| ID | Term |
|---|---|
| D002241 | Carbohydrates |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
145 mg/day, oral pill, 9 days |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo |
Matched Placebo |
|
|
| 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. | Posted | Mean | Standard Deviation | drinks/week | 1 week |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | Placebo | Matched Placebo | 0 | 25 | 2 | 25 |
Not provided
Not provided
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000144 |
| Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001577 | Benzophenones |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
| D007659 | Ketones |
| Drinks/week Change |
|