N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

Alcoholism Clinical Trial

Official title:

N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01214083
• Other study ID #: CDA-2-014-09F
• Status: Completed
• Phase: Phase 2
• Start date: October 15, 2010
• Est. completion date: October 30, 2016

Study information

• Verified date: March 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: October 30, 2016
• Est. primary completion date: September 30, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcoholism

Intervention

Drug:
• N-acetylcysteine + high-dose naltrexone (150 mg)
All subjects will be evaluated weekly for 12 weeks.
• High-dose naltrexone (150 mg) alone
All subjects will be evaluated weekly for 12 weeks.
• Low-dose naltrexone (50 mg) alone
All subjects will be evaluated weekly for 12 weeks.

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System, Minneapolis, MN	Minneapolis	Minnesota
United States	VA Connecticut Healthcare System West Haven Campus, West Haven, CT	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	week 1 and week 13
Secondary	Liver Function Tests (AST)		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).	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).	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).	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).	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).	week 1 and week 13
Secondary	Drinks Per Drinking Days		week 1 and week 13
Secondary	Liver Function Tests (ALT)		week 0 and week 13