Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01214083
First received: September 30, 2010
Last updated: June 13, 2016
Last verified: June 2016
  Purpose
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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Percentage of heavy drinking days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Liver function tests [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Penn Alcohol Craving Scale (PACS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Obsessive Compulsive Drinking Scale (OCDS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • percentage of drinking days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • drinks per drinking days [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: September 2016
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214083

Locations
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 Minneapolis VA Health Care System, Minneapolis, MN
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01214083     History of Changes
Other Study ID Numbers: CDA-2-014-09F 
Study First Received: September 30, 2010
Last Updated: June 13, 2016
Health Authority: United States: Federal Government
Individual Participant Data  
Plan to Share IPD: Undecided

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
Acetylcysteine
N-monoacetylcystine
Naltrexone
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 23, 2016