N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01214083
• Date of registration: 30/09/2010
• Primary sponsor: Department of Veterans Affairs
• Public title: N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
• Scientific title: N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
• Date of first enrolment: October 2010
• Target sample size: 150
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01214083
• 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

Countries of recruitment

United States

Contacts

• Name: Katie Thompson, MS

• Name: Katie Thompson, MS

• Name: Gihyun Yoon, MD
• Affiliation: Minneapolis Veterans Affairs Medical Center

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alcoholism

Intervention(s)

Drug: High-dose naltrexone (150 mg) alone

Drug: Low-dose naltrexone (50 mg) alone

Drug: N-acetylcysteine + high-dose naltrexone (150 mg)

Primary Outcome(s)

Percentage of heavy drinking days [Time Frame: 12 weeks]

Secondary Outcome(s)

Clinical Global Impression (CGI) [Time Frame: 12 weeks]

drinks per drinking days [Time Frame: 12 weeks]

Liver function tests [Time Frame: 12 weeks]

Obsessive Compulsive Drinking Scale (OCDS) [Time Frame: 12 weeks]

Penn Alcohol Craving Scale (PACS) [Time Frame: 12 weeks]

percentage of drinking days [Time Frame: 12 weeks]

Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [Time Frame: 12 weeks]

Secondary ID(s)

CDA-2-014-09F

Source(s) of Monetary Support

Please refer to primary and secondary sponsors