NCT00568087

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Dec 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

December 4, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 5, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4.3 years until next milestone

Results Posted

Study results publicly available

November 1, 2013

Completed
Last Updated

March 18, 2020

Status Verified

March 1, 2020

Enrollment Period

1.7 years

First QC Date

December 4, 2007

Results QC Date

June 14, 2013

Last Update Submit

March 13, 2020

Conditions

Alcoholism

Keywords

N-acetylcysteineAlcoholismTreatment

Outcome Measures

Primary Outcomes (1)

  • Alcohol Consumption (Percentage of Heavy Drinking Days)

    The percentage of heavy drinking days was primary a priori outcome measure. Heavy drinking was defined as ≥ 5 standard drinks per day for men and ≥ 4 standard drinks for women. One standard drink is any drink containing about 0.6 fluid ounces or 14 grams of pure alcohol. The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). At each week, the percentage of HDD was calculated during the period (usually 7 days) since the last previous visit.

    The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.

Secondary Outcomes (3)

  • The Penn Alcohol Craving Scale

    The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.

  • The Obsessive Compulsive Drinking Scale

    The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.

  • Liver Function Tests

    8 weeks

Study Arms (2)

N-acetylcysteine

ACTIVE COMPARATOR

Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day.

Drug: N-acetylcysteine

Placebo

PLACEBO COMPARATOR

Patients will take oral placebo (identical matching placebo) during the study period.

Drug: Placebo

Interventions

N-acetylcysteineDRUG

Patients will take oral N-acetylcysteine 900 mg/day for 1 week, 1800 mg/day for 1 week, 2700 mg/day for 1 week, and then 3600 mg/day.

N-acetylcysteine
PlaceboDRUG

Patients will take oral placebo (identical matching placebo) during the study period.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 - 65
  • alcohol dependence by DSM-IV
  • heavy drinking at least 4 times in the past month
  • able to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Medical Center

Minneapolis, Minnesota, 55417, United States

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

CysteineAmino Acids, SulfurSulfur CompoundsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Gihyun Yoon, MD
Organization
Minneapolis VA Health Care System
Gihyun.Yoon@va.gov
612-467-3996

Study Officials

  • Gihyun Yoon, MD

    Minneapolis Veterans Affairs Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychiatrist

Study Record Dates

First Submitted

December 4, 2007

First Posted

December 5, 2007

Study Start

December 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

March 18, 2020

Results First Posted

November 1, 2013

Record last verified: 2020-03

Locations

US(1)