N-acetylcysteine Plus Naltrexone for the Treatment of Alcohol Dependence
NCT ID: NCT01214083
Last Updated: 2020-04-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2010-10-15
2016-10-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Naltrexone on Alcohol Craving and on Brain Activity During Alcohol Infusion
NCT00667771
Naltrexone for Heavy Drinking in Young Adults
NCT00568958
Targeted Naltrexone for Problem Drinkers
NCT00369408
Combination of Naltrexone and Baclofen for Alcohol Dependence:A Pilot Study.
NCT00614328
Collaborative Care for Alcohol Use Disorders in the Patient-centered Medical Home
NCT02885311
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm 1
N-acetylcysteine + high-dose naltrexone (150 mg)
N-acetylcysteine + high-dose naltrexone (150 mg)
All subjects will be evaluated weekly for 12 weeks.
Arm 2
High-dose naltrexone (150 mg) alone
High-dose naltrexone (150 mg) alone
All subjects will be evaluated weekly for 12 weeks.
Arm 3
Low-dose naltrexone (50 mg) alone
Low-dose naltrexone (50 mg) alone
All subjects will be evaluated weekly for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
VA Office of Research and Development
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gihyun Yoon, MD
Role: PRINCIPAL_INVESTIGATOR
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Connecticut Healthcare System West Haven Campus, West Haven, CT
West Haven, Connecticut, United States
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CDA-2-014-09F
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.