Alcoholism
Conditions
Keywords
N-acetylcysteine, Alcoholism, Treatment
Brief summary
The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.
Detailed description
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.
Interventions
DRUGN-acetylcysteine
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.
DRUGPlacebo
Patients will take oral placebo (identical matching placebo) during the study period.
Sponsors
Minnesota Veterans Medical Research and Education Foundation
Minneapolis Veterans Affairs Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age 18 - 65 * alcohol dependence by DSM-IV * heavy drinking at least 4 times in the past month * able to provide informed consent
Exclusion criteria
* current drug abuse or dependence by DSM-IV criteria (except nicotine or cannabis) * current psychotic disorders, bipolar disorders, or cognitive disorders * current suicidal or homicidal ideation * positive illicit drug screen (except cannabis) * Clinical Institute Withdrawal Assessment for Alcohol, Revised \>15 * initiation of individual therapy or counseling in the past 3 months * changes in doses of psychiatric medications in the past 3 months * clinically unstable cardiac, hepatic, renal, neurologic, or pulmonary disease * current use of naltrexone, disulfiram or acamprosate * pregnant or nursing women, or inadequate birth control methods in women of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Consumption (Percentage of Heavy Drinking Days) | The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Penn Alcohol Craving Scale | The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks. | 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. |
| The Obsessive Compulsive Drinking Scale | The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks. | 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. |
| Liver Function Tests | 8 weeks | Aspartate aminotransaminase (AST) plasma level |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| N-acetylcysteine N-acetylcysteine daily for 8 weeks | 22 |
| Placebo Identical placebo daily for 8 weeks | 24 |
| Total | 46 |
Baseline characteristics
| Characteristic | Placebo | N-acetylcysteine | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 23 Participants | 22 Participants | 45 Participants |
| Age, Continuous | 56.5 years STANDARD_DEVIATION 7 | 50.1 years STANDARD_DEVIATION 11.3 | 53.5 years STANDARD_DEVIATION 9.8 |
| Region of Enrollment United States | 24 participants | 22 participants | 46 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 4 Participants |
| Sex: Female, Male Male | 22 Participants | 20 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 21 | 4 / 23 |
| serious Total, serious adverse events | 0 / 21 | 0 / 23 |
Outcome results
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.
Time frame: The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.
Population: All 44 subjects who received intervention were included in analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-acetylcysteine | Alcohol Consumption (Percentage of Heavy Drinking Days) | Percentage of heavy drinking days at week 1 | 70.2 percentage of heavy drinking days | Standard Error 7.1 |
| N-acetylcysteine | Alcohol Consumption (Percentage of Heavy Drinking Days) | Percentage of heavy drinking days at week 9 | 20.2 percentage of heavy drinking days | Standard Error 8.6 |
| Placebo | Alcohol Consumption (Percentage of Heavy Drinking Days) | Percentage of heavy drinking days at week 1 | 58.4 percentage of heavy drinking days | Standard Error 6.7 |
| Placebo | Alcohol Consumption (Percentage of Heavy Drinking Days) | Percentage of heavy drinking days at week 9 | 14.7 percentage of heavy drinking days | Standard Error 5.5 |
Secondary
Liver Function Tests
Aspartate aminotransaminase (AST) plasma level
Time frame: 8 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-acetylcysteine | Liver Function Tests | AST at week 0 | 40.89 U/L | Standard Deviation 32.49 |
| N-acetylcysteine | Liver Function Tests | AST at week 9 | 26.13 U/L | Standard Deviation 10.39 |
| Placebo | Liver Function Tests | AST at week 0 | 35.85 U/L | Standard Deviation 31.45 |
| Placebo | Liver Function Tests | AST at week 9 | 31.53 U/L | Standard Deviation 29.69 |
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.
Time frame: The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-acetylcysteine | The Obsessive Compulsive Drinking Scale | Obsessive Compulsive Drinking Scale at week 1 | 29.0 score on a scale | Standard Error 1.7 |
| N-acetylcysteine | The Obsessive Compulsive Drinking Scale | Obsessive Compulsive Drinking Scale at week 9 | 13.8 score on a scale | Standard Error 2.9 |
| Placebo | The Obsessive Compulsive Drinking Scale | Obsessive Compulsive Drinking Scale at week 1 | 27.6 score on a scale | Standard Error 2.1 |
| Placebo | The Obsessive Compulsive Drinking Scale | Obsessive Compulsive Drinking Scale at week 9 | 17.0 score on a scale | Standard Error 2.3 |
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.
Time frame: The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| N-acetylcysteine | The Penn Alcohol Craving Scale | Penn Alcohol Craving Scale at week 1 | 18.1 score on a scale | Standard Error 1.5 |
| N-acetylcysteine | The Penn Alcohol Craving Scale | Penn Alcohol Craving Scale at week 9 | 7.2 score on a scale | Standard Error 1.7 |
| Placebo | The Penn Alcohol Craving Scale | Penn Alcohol Craving Scale at week 1 | 18.0 score on a scale | Standard Error 1.3 |
| Placebo | The Penn Alcohol Craving Scale | Penn Alcohol Craving Scale at week 9 | 11.5 score on a scale | Standard Error 1.3 |