N-acetylcysteine in Alcohol Dependence
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
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
- 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
- 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.
- 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.
- Liver Function Tests [8 weeks]
Aspartate aminotransaminase (AST) plasma level
Eligibility Criteria
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
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.- Protocol #3852-B
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
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)
|
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)
|
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)
|
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
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 |
Gihyun.Yoon@va.gov |
- Protocol #3852-B