Back to resultsN-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Primary Purpose
Alcoholism
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
N-acetylcysteine + high-dose naltrexone (150 mg)
High-dose naltrexone (150 mg) alone
Low-dose naltrexone (50 mg) alone
Sponsored by
About this trial
This is an interventional treatment trial for Alcoholism focused on measuring N-acetylcysteine, naltrexone
Eligibility Criteria
Inclusion Criteria:
- age 18-65 years
- alcohol dependence by DSM-IV criteria
- heavy drinking at least 6 times within the past month ('heavy drinking' defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women)
- able to provide informed consent
- a score of 6 or more on the Penn Alcohol Craving Scale (PACS)
- subject agrees not to take over-the-counter analgesics during the study
Exclusion Criteria:
- current drug abuse or dependence by DSM-IV criteria (except nicotine and marijuana)
- current psychotic disorders or bipolar disorders
- current suicidal or homicidal ideation
- positive illicit drug screen test (except marijuana)
- ongoing narcotic use or risks for narcotic use during the study
- increased risk for severe alcohol withdrawal by a score of 10 or more on the Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)
- clinically significant cardiac, hepatic, renal, neurologic, or pulmonary disease
- baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times normal
- current use of disulfiram, acamprosate or topiramate
- pregnant or nursing, or inadequate birth control methods in women of childbearing potential
- alcohol breathalyzer level 0.08 or more at the screening visit
- severe alcohol withdrawal (delirium tremens or withdrawal seizures) within the past year
- currently requiring inpatient treatment for treating alcohol dependence
Sites / Locations
- VA Connecticut Healthcare System West Haven Campus, West Haven, CT
- Minneapolis VA Health Care System, Minneapolis, MN
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Arm 1
Arm 2
Arm 3
Arm Description
N-acetylcysteine + high-dose naltrexone (150 mg)
High-dose naltrexone (150 mg) alone
Low-dose naltrexone (50 mg) alone
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Liver Function Tests (AST)
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).
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).
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).
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).
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).
Drinks Per Drinking Days
Liver Function Tests (ALT)
Full Information
NCT ID
NCT01214083
First Posted
September 30, 2010
Last Updated
March 31, 2020
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT01214083
Brief Title
N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Official Title
N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 15, 2010 (Actual)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
October 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcoholism
Keywords
N-acetylcysteine, naltrexone
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
111 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Description
N-acetylcysteine + high-dose naltrexone (150 mg)
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
High-dose naltrexone (150 mg) alone
Arm Title
Arm 3
Arm Type
Active Comparator
Arm Description
Low-dose naltrexone (50 mg) alone
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine + high-dose naltrexone (150 mg)
Intervention Description
All subjects will be evaluated weekly for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
High-dose naltrexone (150 mg) alone
Intervention Description
All subjects will be evaluated weekly for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Low-dose naltrexone (50 mg) alone
Intervention Description
All subjects will be evaluated weekly for 12 weeks.
Primary Outcome Measure Information:
Title
Percentage of Heavy Drinking Days
Description
"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).
Time Frame
week 1 and week 13
Secondary Outcome Measure Information:
Title
Liver Function Tests (AST)
Time Frame
week 0 and week 13
Title
Penn Alcohol Craving Scale (PACS)
Description
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).
Time Frame
week 1 and week 13
Title
Obsessive Compulsive Drinking Scale (OCDS)
Description
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).
Time Frame
week 1 and week 13
Title
Clinical Global Impression (CGI)
Description
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).
Time Frame
week 1 and week 13
Title
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Description
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).
Time Frame
week 1 and week 13
Title
Percentage of Drinking Days
Description
"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).
Time Frame
week 1 and week 13
Title
Drinks Per Drinking Days
Time Frame
week 1 and week 13
Title
Liver Function Tests (ALT)
Time Frame
week 0 and week 13
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age 18-65 years
alcohol dependence by DSM-IV criteria
heavy drinking at least 6 times within the past month ('heavy drinking' defined as 5 or more standard drinks per day for men and 4 or more standard drinks for women)
able to provide informed consent
a score of 6 or more on the Penn Alcohol Craving Scale (PACS)
subject agrees not to take over-the-counter analgesics during the study
Exclusion Criteria:
current drug abuse or dependence by DSM-IV criteria (except nicotine and marijuana)
current psychotic disorders or bipolar disorders
current suicidal or homicidal ideation
positive illicit drug screen test (except marijuana)
ongoing narcotic use or risks for narcotic use during the study
increased risk for severe alcohol withdrawal by a score of 10 or more on the Clinical Institute Withdrawal Assessment for Alcohol, Revised (CIWA-Ar)
clinically significant cardiac, hepatic, renal, neurologic, or pulmonary disease
baseline aspartate aminotransferase (AST) or alanine aminotransferase (ALT) greater than 3 times normal
current use of disulfiram, acamprosate or topiramate
pregnant or nursing, or inadequate birth control methods in women of childbearing potential
alcohol breathalyzer level 0.08 or more at the screening visit
severe alcohol withdrawal (delirium tremens or withdrawal seizures) within the past year
currently requiring inpatient treatment for treating alcohol dependence
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gihyun Yoon, MD
Organizational Affiliation
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Minneapolis VA Health Care System, Minneapolis, MN
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
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