N-acetylcysteine in Alcohol Dependence

Sponsor
Minneapolis Veterans Affairs Medical Center (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00568087
Collaborator
Minnesota Veterans Medical Research and Education Foundation (Other)
46
1
2
20
2.3

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
N-acetylcysteine in Alcohol Dependence
Study Start Date :
Dec 1, 2007
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Aug 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: N-acetylcysteine

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
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.

Placebo Comparator: Placebo

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

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

Outcome Measures

Primary Outcome Measures

  1. Alcohol Consumption (Percentage of Heavy Drinking Days) [The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.]

    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.

Secondary Outcome Measures

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

    Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). The Penn Alcohol Craving Scale is a self-rated scale designed to assess alcohol craving. The score range of the Penn Alcohol Craving Scale is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving.

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

    Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). The Obsessive Compulsive Drinking Scale is a self-rated scale designed to assess alcohol craving. The score range of the Obsessive Compulsive Drinking Scale is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving.

  3. Liver Function Tests [8 weeks]

    Aspartate aminotransaminase (AST) plasma level

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Minneapolis VA Medical Center Minneapolis Minnesota United States 55417

Sponsors and Collaborators

  • Minneapolis Veterans Affairs Medical Center
  • Minnesota Veterans Medical Research and Education Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gihyun Yoon, Psychiatrist, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00568087
Other Study ID Numbers:
  • Protocol #3852-B
First Posted:
Dec 5, 2007
Last Update Posted:
Mar 18, 2020
Last Verified:
Mar 1, 2020
Keywords provided by Gihyun Yoon, Psychiatrist, Minneapolis Veterans Affairs Medical Center
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title N-acetylcysteine Placebo
Arm/Group Description N-acetylcysteine daily for 8 weeks Identical placebo daily for 8 weeks
Period Title: Overall Study
STARTED 22 24
Received Intervention 21 23
COMPLETED 15 17
NOT COMPLETED 7 7

Baseline Characteristics

Arm/Group Title N-acetylcysteine Placebo Total
Arm/Group Description N-acetylcysteine daily for 8 weeks Identical placebo daily for 8 weeks Total of all reporting groups
Overall Participants 22 24 46
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
22
100%
23
95.8%
45
97.8%
>=65 years
0
0%
1
4.2%
1
2.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
50.1
(11.3)
56.5
(7.0)
53.5
(9.8)
Sex: Female, Male (Count of Participants)
Female
2
9.1%
2
8.3%
4
8.7%
Male
20
90.9%
22
91.7%
42
91.3%
Region of Enrollment (participants) [Number]
United States
22
100%
24
100%
46
100%

Outcome Measures

1. Primary Outcome
Title Alcohol Consumption (Percentage of Heavy Drinking Days)
Description 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.
Time Frame The percentage of heavy drinking days (HDD) was measured at each weekly visit during the 8 weeks.

Outcome Measure Data

Analysis Population Description
All 44 subjects who received intervention were included in analysis.
Arm/Group Title N-acetylcysteine Placebo
Arm/Group Description N-acetylcysteine daily for 8 weeks Identical placebo daily for 8 weeks
Measure Participants 21 23
Percentage of heavy drinking days at week 1
70.2
(7.1)
58.4
(6.7)
Percentage of heavy drinking days at week 9
20.2
(8.6)
14.7
(5.5)
2. Secondary Outcome
Title The Penn Alcohol Craving Scale
Description Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). The Penn Alcohol Craving Scale is a self-rated scale designed to assess alcohol craving. The score range of the Penn Alcohol Craving Scale is between 0 and 30, with 30 assigned to the highest (worst) alcohol craving.
Time Frame The Penn Alcohol Craving Scale was measured at each weekly visit during the 8 weeks.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine Placebo
Arm/Group Description N-acetylcysteine daily for 8 weeks Identical placebo daily for 8 weeks
Measure Participants 21 23
Penn Alcohol Craving Scale at week 1
18.1
(1.5)
18.0
(1.3)
Penn Alcohol Craving Scale at week 9
7.2
(1.7)
11.5
(1.3)
3. Secondary Outcome
Title The Obsessive Compulsive Drinking Scale
Description Alcohol craving was secondary a priori outcome measure. Alcohol craving was measured at each weekly visit during the 8 weeks--from week 1 (before starting intervention) to week 9 (after completing intervention). The Obsessive Compulsive Drinking Scale is a self-rated scale designed to assess alcohol craving. The score range of the Obsessive Compulsive Drinking Scale is between 0 and 56, with 56 assigned to the highest (worst) alcohol craving.
Time Frame The Obsessive Compulsive Drinking Scale was measured at each weekly visit during the 8 weeks.

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine Placebo
Arm/Group Description N-acetylcysteine daily for 8 weeks Identical placebo daily for 8 weeks
Measure Participants 21 23
Obsessive Compulsive Drinking Scale at week 1
29.0
(1.7)
27.6
(2.1)
Obsessive Compulsive Drinking Scale at week 9
13.8
(2.9)
17.0
(2.3)
4. Secondary Outcome
Title Liver Function Tests
Description Aspartate aminotransaminase (AST) plasma level
Time Frame 8 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title N-acetylcysteine Placebo
Arm/Group Description N-acetylcysteine daily for 8 weeks Identical placebo daily for 8 weeks
Measure Participants 21 23
AST at week 0
40.89
(32.49)
35.85
(31.45)
AST at week 9
26.13
(10.39)
31.53
(29.69)

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title N-acetylcysteine Placebo
Arm/Group Description N-acetylcysteine daily for 8 weeks Identical placebo daily for 8 weeks
All Cause Mortality
N-acetylcysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
N-acetylcysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/21 (0%) 0/23 (0%)
Other (Not Including Serious) Adverse Events
N-acetylcysteine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 4/21 (19%) 4/23 (17.4%)
Gastrointestinal disorders
Flatulence 1/21 (4.8%) 1/23 (4.3%)
Stomach discomfort 1/21 (4.8%) 1/23 (4.3%)
Vomiting 1/21 (4.8%) 0/23 (0%)
General disorders
Increased appetite 0/21 (0%) 1/23 (4.3%)
Flushed face 0/21 (0%) 1/23 (4.3%)
Dizziness 1/21 (4.8%) 0/23 (0%)
Headache 1/21 (4.8%) 0/23 (0%)
Increased urination 1/21 (4.8%) 0/23 (0%)
Anxiety 1/21 (4.8%) 0/23 (0%)
Sweating 0/21 (0%) 1/23 (4.3%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Gihyun Yoon, MD
Organization Minneapolis VA Health Care System
Phone 612-467-3996
Email Gihyun.Yoon@va.gov
Responsible Party:
Gihyun Yoon, Psychiatrist, Minneapolis Veterans Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00568087
Other Study ID Numbers:
  • Protocol #3852-B
First Posted:
Dec 5, 2007
Last Update Posted:
Mar 18, 2020
Last Verified:
Mar 1, 2020