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| ID | Type | Description | Link |
|---|---|---|---|
| R21AA026129 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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This study will evaluate the behavioral effects of alcohol during placebo and n-acetylcysteine maintenance using sophisticated human laboratory methods.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects will receive oral placebo capsules two times daily. |
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| Low Dose n-Acetylcysteine | Experimental | Subjects will receive 0.6 g oral n-acetylcysteine two times daily. |
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| High Dose n-Acetylcysteine | Experimental | Subjects will receive 1.2 g oral n-acetylcysteine two times daily. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alcohol | Drug | During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Alcohol Drinks Chosen | The reinforcing effects of alcohol were determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo and n-acetylcysteine. | After at least four days of placebo or n-acetylcysteine maintenance |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| William W Stoops, PhD | University of Kentucky | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40507 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Then 1.2 g n-Acetylcysteine Then 2.4 g n-Acetylcysteine | Subjects were maintained on placebo for 5 days, then they were maintained on 1.2 g n-acetylcysteine daily for 5 days, then they were maintained on 2.4 g n-acetylcysteine for 5 days. |
| FG001 | 2.4 g n-Acetylcysteine Then 1.2 g n-Acetylcysteine Then Placebo | Subjects were maintained on 2.4 g n-acetylcysteine for 5 days, then they were maintained on 1.2 g n-acetylcysteine daily for 5 days, then they were maintained on placebo for 5 days. |
| FG002 | Placebo Then 2.4 g n-Acetylcysteine Then 1.2 g n-Acetylcysteine | Subjects were maintained on placebo for 5 days, then they were maintained on 2.4 g n-acetylcysteine, then they were maintained on 1.2 g n-acetylcysteine. |
| FG003 | 1.2 g n-Acetylcysteine Then Placebo Then 2.4 g n-Acetylcysteine | Subjects were maintained on 1.2 g n-acetylcysteine for 5 days, then they were maintained on placebo for 5 days, then they were maintained on 2.4 g n-acetylcysteine for 5 days. |
| FG004 | 1.2 g n-Acetylcysteine Then 2.4 g n-Acetylcysteine Then Placebo | Subjects were maintained on 1.2 g n-acetylcysteine for 5 days then they were maintained on 2.4 g n-acetylcysteine for 5 days, then they were maintained on placebo. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Completing subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Crossover Study Drug Conditions | Subjects received oral placebo, 0.6 g n-acetylcysteine or 1.2 g n-acetylcysteine capsules two times daily. Dose condition was assigned in random order and all completing subjects received all dose conditions. Alcohol: During each condition, subjects received doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl. Placebos: Subjects received placebo capsules. n-Acetylcysteine: Subjects received n-acetylcysteine capsules. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Number of Alcohol Drinks Chosen | The reinforcing effects of alcohol were determined using a self-administration procedure in which subjects choose to take previously sampled doses. Reinforcing effects are measured during maintenance on placebo and n-acetylcysteine. | Completing Subjects | Posted | Mean | Standard Deviation | Number of Alcohol Drinks Chosen | After at least four days of placebo or n-acetylcysteine maintenance |
|
Full duration of each subject's participation, approximately 5 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 | Placebo Maintenance | Subjects received oral placebo capsules two times daily. Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl. Placebos: Subjects received placebo capsules |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment | During placebo maintenance |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William W. Stoops, PhD | University of Kentucky | 859-257-5388 | william.stoops@uky.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 3, 2020 | Jan 5, 2021 | ICF_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 15, 2020 | Jan 5, 2021 | Prot_SAP_002.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 |
|---|---|
| D000431 | Ethanol |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
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| Placebos | Drug | Subjects will receive placebo capsules |
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| N-acetyl cysteine | Drug | Subjects will receive n-acetyl cysteine capsules |
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| Withdrawal by Subject |
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| Subject used cocaine during participation, which is an exclusion criterion. |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Subjects received 0.6 g oral n-acetylcysteine two times daily. Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl. N-acetyl cysteine: Subjects will receive n-acetyl cysteine capsules |
| OG002 | High Dose n-Acetylcysteine | Subjects received 1.2 g oral n-acetylcysteine two times daily. Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl. N-acetyl cysteine: Subjects will receive n-acetyl cysteine capsules |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 1 |
| 14 |
| EG001 | 1.2 g n-Acetylcysteine Maintenance | Subjects received 0.6 g n-acetylcysteine capsules two times daily. Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl. Placebos: Subjects received placebo capsules n-Acetylcysteine: Subjects received 0.6 g n-acetylcysteine capsules | 0 | 14 | 0 | 14 | 1 | 14 |
| EG002 | 2.4 g n-Acetylcysteine Maintenance | Subjects received 1.2 g n-acetylcysteine capsules two times daily. Alcohol: During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl. Placebos: Subjects received placebo capsules n-Acetylcysteine: Subjects received 1.2 g n-acetylcysteine capsules | 0 | 14 | 0 | 14 | 0 | 14 |
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment | During placebo maintenance |
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| Blurry vision | Eye disorders | Non-systematic Assessment | during 1.2 g n-acetylcysteine/day maintenance |
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| Dizziness | Nervous system disorders | Non-systematic Assessment | during 1.2 g n-acetylcysteine/day maintenance |
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| Thirst | General disorders | Non-systematic Assessment | during 1.2 g n-acetylcysteine/day maintenance |
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| D013457 |
| Sulfur Compounds |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |