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N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

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ClinicalTrials.gov Identifier: NCT01214083
Recruitment Status : Completed
First Posted : October 4, 2010
Results First Posted : March 28, 2017
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Alcoholism Drug: N-acetylcysteine + high-dose naltrexone (150 mg) Drug: High-dose naltrexone (150 mg) alone Drug: Low-dose naltrexone (50 mg) alone Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 111 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
Actual Study Start Date : October 15, 2010
Actual Primary Completion Date : September 30, 2015
Actual Study Completion Date : October 30, 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1
N-acetylcysteine + high-dose naltrexone (150 mg)
Drug: N-acetylcysteine + high-dose naltrexone (150 mg)
All subjects will be evaluated weekly for 12 weeks.
Experimental: Arm 2
High-dose naltrexone (150 mg) alone
Drug: High-dose naltrexone (150 mg) alone
All subjects will be evaluated weekly for 12 weeks.
Active Comparator: Arm 3
Low-dose naltrexone (50 mg) alone
Drug: Low-dose naltrexone (50 mg) alone
All subjects will be evaluated weekly for 12 weeks.



Primary Outcome Measures :
  1. Percentage of Heavy Drinking Days [ Time Frame: week 1 and week 13 ]
    "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 :
  1. Liver Function Tests (AST) [ Time Frame: week 0 and week 13 ]
  2. Penn Alcohol Craving Scale (PACS) [ Time Frame: week 1 and week 13 ]
    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).

  3. Obsessive Compulsive Drinking Scale (OCDS) [ Time Frame: week 1 and week 13 ]
    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).

  4. Clinical Global Impression (CGI) [ Time Frame: week 1 and week 13 ]
    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).

  5. Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: week 1 and week 13 ]
    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).

  6. Percentage of Drinking Days [ Time Frame: week 1 and week 13 ]
    "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).

  7. Drinks Per Drinking Days [ Time Frame: week 1 and week 13 ]
  8. Liver Function Tests (ALT) [ Time Frame: week 0 and week 13 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214083


Locations
United States, Connecticut
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States, 06516
United States, Minnesota
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States, 55417
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Gihyun Yoon, MD VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01214083     History of Changes
Other Study ID Numbers: CDA-2-014-09F
First Posted: October 4, 2010    Key Record Dates
Results First Posted: March 28, 2017
Last Update Posted: March 20, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by VA Office of Research and Development:
N-acetylcysteine
naltrexone

Additional relevant MeSH terms:
Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Acetylcysteine
N-monoacetylcystine
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes