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Trial Outcomes & Findings for N-acetylcysteine in Alcohol Dependence (NCT NCT00568087)

NCT ID: NCT00568087

Last Updated: 2020-03-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

46 participants

Primary outcome timeframe

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

Results posted on

2020-03-18

Participant Flow

Participant milestones

Participant milestones
Measure
N-acetylcysteine
N-acetylcysteine daily for 8 weeks
Placebo
Identical placebo daily for 8 weeks
Overall Study
STARTED
22
24
Overall Study
Received Intervention
21
23
Overall Study
COMPLETED
15
17
Overall Study
NOT COMPLETED
7
7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

N-acetylcysteine in Alcohol Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
N-acetylcysteine
n=22 Participants
N-acetylcysteine daily for 8 weeks
Placebo
n=24 Participants
Identical placebo daily for 8 weeks
Total
n=46 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
22 Participants
n=5 Participants
23 Participants
n=7 Participants
45 Participants
n=5 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Age, Continuous
50.1 years
STANDARD_DEVIATION 11.3 • n=5 Participants
56.5 years
STANDARD_DEVIATION 7.0 • n=7 Participants
53.5 years
STANDARD_DEVIATION 9.8 • n=5 Participants
Sex: Female, Male
Female
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Sex: Female, Male
Male
20 Participants
n=5 Participants
22 Participants
n=7 Participants
42 Participants
n=5 Participants
Region of Enrollment
United States
22 participants
n=5 Participants
24 participants
n=7 Participants
46 participants
n=5 Participants

PRIMARY outcome

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

Population: All 44 subjects who received intervention were included in analysis.

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.

Outcome measures

Outcome measures
Measure
N-acetylcysteine
n=21 Participants
N-acetylcysteine daily for 8 weeks
Placebo
n=23 Participants
Identical placebo daily for 8 weeks
Alcohol Consumption (Percentage of Heavy Drinking Days)
Percentage of heavy drinking days at week 1
70.2 percentage of heavy drinking days
Standard Error 7.1
58.4 percentage of heavy drinking days
Standard Error 6.7
Alcohol Consumption (Percentage of Heavy Drinking Days)
Percentage of heavy drinking days at week 9
20.2 percentage of heavy drinking days
Standard Error 8.6
14.7 percentage of heavy drinking days
Standard Error 5.5

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
N-acetylcysteine
n=21 Participants
N-acetylcysteine daily for 8 weeks
Placebo
n=23 Participants
Identical placebo daily for 8 weeks
The Penn Alcohol Craving Scale
Penn Alcohol Craving Scale at week 1
18.1 score on a scale
Standard Error 1.5
18.0 score on a scale
Standard Error 1.3
The Penn Alcohol Craving Scale
Penn Alcohol Craving Scale at week 9
7.2 score on a scale
Standard Error 1.7
11.5 score on a scale
Standard Error 1.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
N-acetylcysteine
n=21 Participants
N-acetylcysteine daily for 8 weeks
Placebo
n=23 Participants
Identical placebo daily for 8 weeks
The Obsessive Compulsive Drinking Scale
Obsessive Compulsive Drinking Scale at week 1
29.0 score on a scale
Standard Error 1.7
27.6 score on a scale
Standard Error 2.1
The Obsessive Compulsive Drinking Scale
Obsessive Compulsive Drinking Scale at week 9
13.8 score on a scale
Standard Error 2.9
17.0 score on a scale
Standard Error 2.3

SECONDARY outcome

Timeframe: 8 weeks

Aspartate aminotransaminase (AST) plasma level

Outcome measures

Outcome measures
Measure
N-acetylcysteine
n=21 Participants
N-acetylcysteine daily for 8 weeks
Placebo
n=23 Participants
Identical placebo daily for 8 weeks
Liver Function Tests
AST at week 0
40.89 U/L
Standard Deviation 32.49
35.85 U/L
Standard Deviation 31.45
Liver Function Tests
AST at week 9
26.13 U/L
Standard Deviation 10.39
31.53 U/L
Standard Deviation 29.69

Adverse Events

N-acetylcysteine

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Placebo

Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
N-acetylcysteine
n=21 participants at risk
N-acetylcysteine daily for 8 weeks
Placebo
n=23 participants at risk
Identical placebo daily for 8 weeks
Gastrointestinal disorders
Flatulence
4.8%
1/21
4.3%
1/23
Gastrointestinal disorders
Stomach discomfort
4.8%
1/21
4.3%
1/23
Gastrointestinal disorders
Vomiting
4.8%
1/21
0.00%
0/23
General disorders
Increased appetite
0.00%
0/21
4.3%
1/23
General disorders
Flushed face
0.00%
0/21
4.3%
1/23
General disorders
Dizziness
4.8%
1/21
0.00%
0/23
General disorders
Headache
4.8%
1/21
0.00%
0/23
General disorders
Increased urination
4.8%
1/21
0.00%
0/23
General disorders
Anxiety
4.8%
1/21
0.00%
0/23
General disorders
Sweating
0.00%
0/21
4.3%
1/23

Additional Information

Gihyun Yoon, MD

Minneapolis VA Health Care System

Phone: 612-467-3996

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place