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The purpose of this study is to determine whether: (1) the combination of N-acetylcysteine + high-dose naltrexone (150 mg) works better than high-dose naltrexone (150 mg) alone in reducing alcohol drinking; and (2) high-dose naltrexone (150 mg) alone works better than low-dose naltrexone (50 mg) alone in reducing alcohol drinking.
The 3 groups (N-acetylcysteine plus naltrexone 150 mg, naltrexone 150 mg, and naltrexone 50 mg) will be compared in a 12-week randomized, double-blind clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | N-acetylcysteine + high-dose naltrexone (150 mg) |
|
| Arm 2 | Experimental | High-dose naltrexone (150 mg) alone |
|
| Arm 3 | Active Comparator | Low-dose naltrexone (50 mg) alone |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N-acetylcysteine + high-dose naltrexone (150 mg) | Drug | All subjects will be evaluated weekly for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Heavy Drinking Days | "Percentage of heavy drinking days" was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking). | week 1 and week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| Liver Function Tests (AST) | week 0 and week 13 | |
| Penn Alcohol Craving Scale (PACS) | The Penn Alcohol Craving Scale is designed to assess alcohol craving severity. The scale has a total score range of 0-30. Higher values represent a worse outcome (i.e., higher craving). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gihyun Yoon, MD | VA Connecticut Healthcare System West Haven Campus, West Haven, CT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Connecticut Healthcare System West Haven Campus, West Haven, CT | West Haven | Connecticut | 06516 | United States | ||
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A total of 111 subjects signed consent. Of 111 subjects, 95 subjects were qualified for the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | N-acetylcysteine + High-dose Naltrexone (150 mg) | N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks. |
| FG001 | High-dose Naltrexone (150 mg) Alone | High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks. |
| FG002 | Low-dose Naltrexone (50 mg) Alone | Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | N-acetylcysteine + High-dose Naltrexone (150 mg) | N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks. |
| BG001 | High-dose Naltrexone (150 mg) Alone |
| 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 | Percentage of Heavy Drinking Days | "Percentage of heavy drinking days" was measured by the Time Line Follow Back (TLFB) Method. ('Heavy drinking' was defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women.) The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more heavy drinking). | Posted | Mean | Standard Error | percentage of heavy drinking days | week 1 and week 13 |
|
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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 + High-dose Naltrexone (150 mg) | N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gihyun Yoon, MD | VA Connecticut Healthcare System | 203-932-5711 | 7421 | 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 |
| D009271 | Naltrexone |
| D012847 | Single Person |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| High-dose naltrexone (150 mg) alone | Drug | All subjects will be evaluated weekly for 12 weeks. |
|
| Low-dose naltrexone (50 mg) alone | Drug | All subjects will be evaluated weekly for 12 weeks. |
|
| week 1 and week 13 |
| Obsessive Compulsive Drinking Scale (OCDS) | The Obsessive Compulsive Drinking Scale is designed to assess obsessive and compulsive aspects of alcoholism. The scale has a total score range of 0-56. Higher values represent a worse outcome (i.e., more alcohol problems). | week 1 and week 13 |
| Clinical Global Impression (CGI) | The Clinical Global Impression is designed to assess overall severity of illness. The scale has a total score range of 1-7. Higher values represent a worse outcome (i.e., severe illness). | week 1 and week 13 |
| Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | The Quality of Life Enjoyment and Satisfaction Questionnaire is designed to assess a quality of life. The scale has a total score range of 16-80. Higher values represent a better outcome (i.e., better quality of life). | week 1 and week 13 |
| Percentage of Drinking Days | "Percentage of drinking days" was measured by the Time Line Follow Back (TLFB) Method. The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more drinking days). | week 1 and week 13 |
| Drinks Per Drinking Days | week 1 and week 13 |
| Liver Function Tests (ALT) | week 0 and week 13 |
| Minneapolis VA Health Care System, Minneapolis, MN |
| Minneapolis |
| Minnesota |
| 55417 |
| United States |
High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
| BG002 | Low-dose Naltrexone (50 mg) Alone | Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG002 | Low-dose Naltrexone (50 mg) Alone | Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks. |
|
|
| Secondary | Liver Function Tests (AST) | Posted | Mean | Standard Error | units/liter | week 0 and week 13 |
|
|
|
| Secondary | Penn Alcohol Craving Scale (PACS) | The Penn Alcohol Craving Scale is designed to assess alcohol craving severity. The scale has a total score range of 0-30. Higher values represent a worse outcome (i.e., higher craving). | Posted | Mean | Standard Error | units on a scale | week 1 and week 13 |
|
|
|
| Secondary | Obsessive Compulsive Drinking Scale (OCDS) | The Obsessive Compulsive Drinking Scale is designed to assess obsessive and compulsive aspects of alcoholism. The scale has a total score range of 0-56. Higher values represent a worse outcome (i.e., more alcohol problems). | Posted | Mean | Standard Error | units on a scale | week 1 and week 13 |
|
|
|
| Secondary | Clinical Global Impression (CGI) | The Clinical Global Impression is designed to assess overall severity of illness. The scale has a total score range of 1-7. Higher values represent a worse outcome (i.e., severe illness). | Posted | Mean | Standard Error | units on a scale | week 1 and week 13 |
|
|
|
| Secondary | Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) | The Quality of Life Enjoyment and Satisfaction Questionnaire is designed to assess a quality of life. The scale has a total score range of 16-80. Higher values represent a better outcome (i.e., better quality of life). | Posted | Mean | Standard Error | units on a scale | week 1 and week 13 |
|
|
|
| Secondary | Percentage of Drinking Days | "Percentage of drinking days" was measured by the Time Line Follow Back (TLFB) Method. The percentage has a total range of 0%-100%. Higher percentages represent a worse outcome (i.e., more drinking days). | Posted | Mean | Standard Error | percentage of drinking days | week 1 and week 13 |
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| Secondary | Drinks Per Drinking Days | Posted | Mean | Standard Error | drinks/drinking day | week 1 and week 13 |
|
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| Secondary | Liver Function Tests (ALT) | Posted | Mean | Standard Error | units/liter | week 0 and week 13 |
|
|
|
| 0 |
| 31 |
| 14 |
| 31 |
| EG001 | High-dose Naltrexone (150 mg) Alone | High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks. | 0 | 33 | 12 | 33 |
| EG002 | Low-dose Naltrexone (50 mg) Alone | Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks. | 0 | 31 | 9 | 31 |
| Drowsiness | General disorders | Systematic Assessment |
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| Headache | General disorders | Systematic Assessment |
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| Decreased appetite | General disorders | Systematic Assessment |
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| Dry mouth | General disorders | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | Systematic Assessment |
|
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| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D017533 | Marital Status |
| D005191 | Family Characteristics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D012959 | Socioeconomic Factors |
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