Expired Study
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Minneapolis, Minnesota 55417


Purpose:

The present study is designed to find out if N-acetylcysteine works in reducing alcohol drinking and craving.


Study summary:

The 2 groups (placebo and N-acetylcysteine) will be compared in a double-blind, placebo-controlled trial. The total study duration is 9 weeks which includes a 1-week screening period and an 8-week randomized study drug treatment period.


Criteria:

Inclusion Criteria: - age 18 - 65 - alcohol dependence by DSM-IV - heavy drinking at least 4 times in the past month - able to provide informed consent Exclusion Criteria: - current drug abuse or dependence by DSM-IV criteria (except nicotine or cannabis) - current psychotic disorders, bipolar disorders, or cognitive disorders - current suicidal or homicidal ideation - positive illicit drug screen (except cannabis) - Clinical Institute Withdrawal Assessment for Alcohol, Revised >15 - initiation of individual therapy or counseling in the past 3 months - changes in doses of psychiatric medications in the past 3 months - clinically unstable cardiac, hepatic, renal, neurologic, or pulmonary disease - current use of naltrexone, disulfiram or acamprosate - pregnant or nursing women, or inadequate birth control methods in women of childbearing potential


Study is Available At:


Original ID:

Protocol #3852-B


NCT ID:

NCT00568087


Secondary ID:


Study Acronym:


Brief Title:

N-acetylcysteine in Alcohol Dependence


Official Title:

N-acetylcysteine in Alcohol Dependence


Overall Status:

Completed


Study Phase:

Phase 1/Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Minneapolis Veterans Affairs Medical Center


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

46


Enrollment Type:

Actual


Overall Contact Information

Official Name:Gihyun Yoon, MD
Principal Investigator
Minneapolis Veterans Affairs Medical Center

Study Dates

Start Date:December 2007
Completion Date:August 2009
Completion Type:Actual
Primary Completion Date:August 2009
Primary Completion Type:Actual
Verification Date:April 2013
Last Changed Date:April 22, 2013
First Received Date:December 4, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Liver function tests
Time Frame:8 weeks
Safety Issues:True
Outcome Type:Primary Outcome
Measure:Alcohol consumption
Time Frame:8 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:N-acetylcysteine
Description:Oral N-acetylcysteine daily for 8 weeks
Arm Name:1
Intervention Type:Drug
Name:Placebo
Description:Placebo
Arm Name:2

Study Arms

Study Arm Type:Placebo Comparator
Arm Name:2
Study Arm Type:Active Comparator
Arm Name:1

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Minneapolis Veterans Affairs Medical Center
Agency Class:Other
Agency Type:Collaborator
Agency Name:Minnesota Veterans Research Institute

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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