N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence

NCT01214083 | Completed Phase 2 Results FDA Drug

• 1 other identifier: CDA-2-014-09F
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

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.

Conditions

Alcoholism

Keywords

N-acetylcysteine; naltrexone

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Liver Function Tests (AST)

  week 0 and week 13

• Penn Alcohol Craving Scale (PACS)

  week 1 and week 13

• Obsessive Compulsive Drinking Scale (OCDS)

  week 1 and week 13

• Clinical Global Impression (CGI)

  week 1 and week 13

• Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

  week 1 and week 13

Study Arms (3)

Arm 1

EXPERIMENTAL

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

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

Arm 2

EXPERIMENTAL

High-dose naltrexone (150 mg) alone

Drug: High-dose naltrexone (150 mg) alone

Arm 3

ACTIVE COMPARATOR

Low-dose naltrexone (50 mg) alone

Drug: Low-dose naltrexone (50 mg) alone

Interventions

N-acetylcysteine + high-dose naltrexone (150 mg) DRUG

All subjects will be evaluated weekly for 12 weeks.

Arm 1

High-dose naltrexone (150 mg) alone DRUG

All subjects will be evaluated weekly for 12 weeks.

Arm 2

Low-dose naltrexone (50 mg) alone DRUG

All subjects will be evaluated weekly for 12 weeks.

Arm 3

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

West Haven, Connecticut, 06516, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Acetylcysteine; Naltrexone; Single Person

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Marital Status; Family Characteristics; Demography; Population Characteristics; Socioeconomic Factors

Results Point of Contact

• Title: Gihyun Yoon, MD
• Organization: VA Connecticut Healthcare System

gihyun.yoon@va.gov

203-932-5711

Study Officials

• Gihyun Yoon, MD

  VA Connecticut Healthcare System West Haven Campus, West Haven, CT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 4, 2010
• Study Start: October 15, 2010
• Primary Completion: September 30, 2015
• Study Completion: October 30, 2016
• Last Updated: April 8, 2020
• Results First Posted: March 28, 2017

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)