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| Name | Class |
|---|---|
| Minnesota Veterans Medical Research and Education Foundation | OTHER |
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The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.
The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| N-acetylcysteine | Active Comparator | Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. |
|
| Placebo | Placebo Comparator | Patients will take oral placebo (identical matching placebo) during the study period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine | Drug | Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Alcohol Consumption (Percentage of Heavy Drinking Days) | The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit. | The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The Penn Alcohol Craving Scale | Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). The Penn Alcohol Craving Scale is a self-rated scale designed to assess alcohol craving. The score range of the Penn Alcohol Craving Scale is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gihyun Yoon, MD | Minneapolis Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Medical Center | Minneapolis | Minnesota | 55417 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | N-acetylcysteine | N-acetylcysteine daily for 8 weeks |
| FG001 | Placebo | Identical placebo daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | N-acetylcysteine | N-acetylcysteine daily for 8 weeks |
| BG001 | Placebo | Identical placebo daily for 8 weeks |
| 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 | Alcohol Consumption (Percentage of Heavy Drinking Days) | The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit. | All 44 subjects who received intervention were included in analysis. | Posted | Mean | Standard Error | percentage of heavy drinking days | The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 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 | N-acetylcysteine | N-acetylcysteine daily for 8 weeks |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Flatulence | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gihyun Yoon, MD | Minneapolis VA Health Care System | 612-467-3996 | Gihyun.Yoon@va.gov |
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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 |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo | Drug | Patients will take oral placebo (identical matching placebo) during the study period. |
|
| The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks. |
| The Obsessive Compulsive Drinking Scale | Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). The Obsessive Compulsive Drinking Scale is a self-rated scale designed to assess alcohol craving. The score range of the Obsessive Compulsive Drinking Scale is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving. | The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks. |
| Liver Function Tests | Aspartate aminotransaminase (AST) plasma level | 8 weeks |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
N-acetylcysteine daily for 8 weeks
| OG001 | Placebo | Identical placebo daily for 8 weeks |
|
|
| Secondary | The Penn Alcohol Craving Scale | Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). The Penn Alcohol Craving Scale is a self-rated scale designed to assess alcohol craving. The score range of the Penn Alcohol Craving Scale is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving. | Posted | Mean | Standard Error | score on a scale | The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks. |
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|
|
| Secondary | The Obsessive Compulsive Drinking Scale | Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). The Obsessive Compulsive Drinking Scale is a self-rated scale designed to assess alcohol craving. The score range of the Obsessive Compulsive Drinking Scale is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving. | Posted | Mean | Standard Error | score on a scale | The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks. |
|
|
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| Secondary | Liver Function Tests | Aspartate aminotransaminase (AST) plasma level | Posted | Mean | Standard Deviation | U/L | 8 weeks |
|
|
|
| 0 |
| 21 |
| 4 |
| 21 |
| EG001 | Placebo | Identical placebo daily for 8 weeks | 0 | 23 | 4 | 23 |
| Stomach discomfort | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Increased appetite | General disorders |
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| Flushed face | General disorders |
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| Dizziness | General disorders |
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| Headache | General disorders |
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| Increased urination | General disorders |
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| Anxiety | General disorders |
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| Sweating | General disorders |
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |