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Funds for the study expired
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This study will examine the efficacy of the medication gemfibrozil in reducing alcohol consumption in individuals with an alcohol use disorder who are seeking treatment for alcohol-related problems. Twenty individuals will be randomized to receive four weeks of either gemfibrozil or placebo and retrospective reports of alcohol use will be collected throughout the trial. In addition, brain imaging measures will be collected at baseline and after two weeks of treatment to determine the effects of gemfibrozil on brain functioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemfibrozil | Experimental | Gemfibrozil 600 mg by mouth twice daily |
|
| Placebo | Placebo Comparator | Microcrystalline cellulose powder packaged in capsules identical to the experimental condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemfibrozil 600 MG | Drug | Gemfibrozil capsules (600 mg) taken twice per day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Standard Drinks Per Drinking Day | Average number of standard drinks consumed on drinking days | Baseline |
| Mean Standard Drinks Per Drinking Day | Average number of standard drinks consumed on drinking days | 2 weeks post baseline |
| Mean Standard Drinks Per Drinking Day | Average number of standard drinks consumed on drinking days | 4 weeks post baseline |
| Percent Days Abstinent | Percentage of days of abstinence from alcohol | Baseline |
| Percent Days Abstinent | Percentage of days of abstinence from alcohol | 2 weeks post baseline |
| Percent Days Abstinent | Percentage of days of abstinence from alcohol | 4 weeks post baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mind Research Network | Albuquerque | New Mexico | 87106 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Gemfibrozil | Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day |
| FG001 | Placebo | Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Gemfibrozil | Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day |
| BG001 | Placebo | Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Mean Standard Drinks Per Drinking Day | Average number of standard drinks consumed on drinking days | Posted | Mean | Full Range | Drinks per drinking day | Baseline |
|
4 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gemfibrozil | Gemfibrozil 600 mg by mouth twice daily Gemfibrozil 600 MG: Gemfibrozil capsules (600 mg) taken twice per day |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Eric Claus | The Mind Research Network | 5055151556 | eclaus@mrn.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 27, 2018 | Sep 21, 2021 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 29, 2018 | Sep 21, 2021 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015248 | Gemfibrozil |
| ID | Term |
|---|---|
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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| Placebo oral capsule |
| Drug |
Microcrystalline cellulose powder packaged in capsules identical to the experimental medication |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Mean Standard Drinks Per Drinking Day | Average number of standard drinks consumed on drinking days | The one participant in the placebo condition dropped out before taking any medication | Posted | Mean | Full Range | Drinks per drinking day | 2 weeks post baseline |
|
|
|
| Primary | Mean Standard Drinks Per Drinking Day | Average number of standard drinks consumed on drinking days | The one participant in the placebo condition dropped out before taking any medication | Posted | Mean | Full Range | Drinks per drinking day | 4 weeks post baseline |
|
|
|
| Primary | Percent Days Abstinent | Percentage of days of abstinence from alcohol | Posted | Mean | Full Range | Percentage of abstinent days | Baseline |
|
|
|
| Primary | Percent Days Abstinent | Percentage of days of abstinence from alcohol | The one participant in the placebo condition dropped out before taking any medication | Posted | Mean | Full Range | Percentage of abstinent days | 2 weeks post baseline |
|
|
|
| Primary | Percent Days Abstinent | Percentage of days of abstinence from alcohol | The one participant in the placebo condition dropped out before taking any medication | Posted | Mean | Full Range | Percentage of abstinent days | 4 weeks post baseline |
|
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Placebo | Microcrystalline cellulose powder packaged in capsules identical to the experimental condition Placebo oral capsule: Microcrystalline cellulose powder packaged in capsules identical to the experimental medication | 0 | 1 | 0 | 1 | 0 | 1 |
| Fatigue | Nervous system disorders | Non-systematic Assessment |
|
| Bruising | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |